Coronary Artery Disease (CAD)
Conditions
Keywords
Coronary Artery Disease (CAD), regadenoson, pharmacologic stress
Brief summary
The purpose of this study is to demonstrate that the strength of agreement between single photon emission computed tomography (SPECT) imaging with regadenoson following inadequate exercise stress testing and SPECT imaging with regadenoson alone is not inferior to the strength of agreement between two sequential regadenoson SPECT images without exercise.
Interventions
DRUGRegadenoson
Administered as an intravenous (IV) bolus
PROCEDURESingle photon emission computed tomography (SPECT) myocardial perfusion imaging (MPI)
Sponsors
Astellas Pharma Global Development, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Subjects referred for an exercise or pharmacologic stress test SPECT MPI procedure for the evaluation of coronary artery disease (CAD) are eligible for study participation. Subjects referred for pharmacologic stress should have a reasonable potential of attempting exercise stress. Subject must have one of the following: * a. Past ischemia on any prior imaging stress test without invasive intervention on the artery subtending this territory * b. Subject with known CAD who have symptoms similar to previous ischemic symptoms, or recent onset of symptoms or recently worsened symptoms suggestive of ischemia * c. Diamond Forrester estimated pretest probability of CAD of ≥ 50% * d. History of most recent coronary artery bypass surgery or most recent percutaneous coronary intervention (PCI) \> 10 years (patients who are \> 30 days but less than 10 years post coronary artery bypass graft (CABG) or PCI can be included if they meet criteria a, b, or e) * e. Previously demonstrated 100% occlusion by invasive coronary or computed tomography (CT) angiography without successful intervening revascularization as these foods may alter regadenoson effects
Exclusion criteria
* Subject has a clinically significant illness, medical condition, or laboratory abnormality * Female subject who is pregnant or lactating * Subject is on dialysis for end stage renal disease or has a history of glomerular filtration rate (GFR) \< 15 mL/min (calculated using MDRD \[Modification of Diet in Renal Disease\] formula) * Subject has a history of coronary revascularization by either PCI or CABG within 1 month prior to the rest myocardial perfusion imaging (MPI) * Subject has a pacemaker or an implantable cardioverter defibrillator (ICD) * Subject has a history of acute myocardial infarction (MI) or high risk unstable angina within 30 days prior to the rest MPI or has had cardiac transplantation * Subject has uncontrolled hypertension at any point on Visit 2 prior to exercise testing (i.e., systolic blood pressure (SBP) ≥ 180 or diastolic blood pressure (DBP) ≥ 95 mmHg on two consecutive measurements while at rest). * Subject has severe aortic stenosis or hypertrophic cardiomyopathy with obstruction or has decompensated congestive heart failure * Subject has a history of severe respiratory disease including: asthma, chronic obstructive pulmonary disease (COPD) or other bronchospastic reactive airway disease or who is on 24-hour continuous oxygen
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Proportion of Participants With Majority Reader Self-agreement in Ischemia Assessment Between First and Second Stress Scans | Day 1 (rest scan and first stress scan) and Day 2 -15 (second stress scan) | SPECT scans were reviewed in a blinded fashion by 3 independent expert readers using the 17-segment model for standardized myocardial segmentation. At rest and stress, each segment was scored on a 0 (normal) to 4 (absent contrast/radiotracer uptake) scale by each of the 3 blinded readers according to the amount of contrast or radiotracer the myocardium in the segment absorbed. If the stress score was ≥ 2 and the rest score was less than the stress score, the segment was counted as having a reversible defect. The number of segments with reversible defects was categorized as absence (0 - 1 reversible segments) or presence (≥ 2 defects reversible segments) of ischemia. Each reader was defined as having self-agreement based upon identical categorization of a given participant as absent or present for ischemia for both the initial and second stress visits. Majority agreement is if at least 2 out of the 3 blinded readers demonstrated self-agreement for a given participant. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Proportion of Participants With Agreement in the Assessment of Absence or Presence of Ischemia Between First and Second Stress Scans | Day 1 (stress MPI 1) and Day 2 -15 (stress MPI 2) | The number of segments with reversible defects was assessed by each of the 3 blinded independent expert readers. Based on the median count of the number of reversible defects across the 3 readers, categorized as absence (0 to 1 reversible segments) or presence (≥ 2 reversible defects) of ischemia, the proportion of participants with agreement in the presence and absence of ischemia between the first and second stress scans was calculated. |
| Proportion of Participants With Agreement in the Assessment of Reversible Defects in 3 Categories of Ischemia Between First and Second Stress Scans | Day 1 (stress MPI 1) and Day 2 - 15 (stress MPI 2) | The number of segments with reversible defects was assessed by each of the 3 blinded independent expert readers. Based on the median count of the number of reversible defects across the 3 readers, categorized as 0 to 1, 2 to 4, or ≥ 5 reversible segments, the proportion of participants with agreement in the three ischemia categories between the first and second stress scans was to be calculated. In the reported data, these proportions only include the 0-1 and 2-4 categories; the ≥ 5 category was not included because there were no participants in this category for the Regadenoson Alone group for the initial stress MPI. |
| Proportion of Participants With Agreement in the Summed Stress Score (SSS) Between First and Second Stress Scans | Day 1 (stress MPI 1) and Day 2 - 15 (stress MPI 2) | The 17-segment model for standardized myocardial segmentation was used to analyze MPI scans. Each segment was scored on a 0 to 4 scale according to the amount of contrast or radiotracer the myocardium in the segment absorbed: * 0: normal perfusion * 1: slightly reduced contrast/radiotracer uptake * 2: moderately reduced contrast/radiotracer uptake * 3: severely reduced contrast/radiotracer uptake * 4: absent contrast/radiotracer uptake. The Summed Stress Score (SSS) was calculated as the sum of the stress scores across the 17 segments. The mean value (rounded to the nearest integer) across the 3 readers was computed and the SSS was categorized into 4 group categorical variables based on the score: 0 to 3, 4 to 7, 8 to 11, and ≥ 12. The proportion of participants with agreement in respect to these categories between the two stress scans was calculated. |
| Proportion of Participants With Agreement in the Summed Difference Score (SDS) Between First and Second Stress Scans | Day 1 (rest MPI and stress MPI 1) and Day 2 - 15 (stress MPI 2) | The 17-segment model for standardized myocardial segmentation was used to analyze MPI scans. At rest and stress, each segment was scored on a 0 to 4 scale according to the amount of contrast or radiotracer the myocardium in the segment absorbed: * 0: normal perfusion * 1: slightly reduced contrast/ uptake * 2: moderately reduced contrast/uptake * 3: severely reduced contrast/uptake * 4: absent contrast/uptake. SSS was calculated as the sum of the stress scores across the 17 segments and the Summed Rest Score (SRS) was calculated as the sum of the rest scores across the 17 segments. The Summed Difference Score (SDS) is the difference in the SSS and SRS (SSS - SRS). The mean value (rounded to the nearest integer) across the 3 readers was computed and the SDS was categorized into 3 categorical variables based on the score: 0 to 6, 7 to 13 and ≥ 14. The proportion of participants with agreement in respect to these categories between the two stress scans was calculated. |
| Participants With Less, the Same, or More Reversible Perfusion Defects Shown by the First Stress Scan When Compared to the Second Stress Scan | Day 1 (stress MPI 1) and Day 2-15 (stress MPI 2) | Each reader evaluated the initial stress SPECT MPI scan compared to the participant's second stress SPECT MPI scan (blinded at time of the evaluation) for whether there was Less (-1), the Same (0) or More (1) reversible perfusion defects. The median assessment of the 3 blinded readers was used to summarize the number of participants in each category. |
| Percentage of Participants With Treatment-emergent Clinically Significant Cardiac Events | Within 1 hour for ECG events and up to 24 hours for adverse events after administration of regadenoson | A clinically significant cardiac event is defined as: * Any of the following events found on the Holter electrocardiogram (ECG)/12-Lead ECG within 1 hour after regadenoson administration: * ventricular arrhythmias (sustained ventricular tachycardia, ventricular fibrillation, torsade de pointes, ventricular flutter), * ST-T depression (\> 2 mm), * ST-T elevation (≥1 mm), * Atrioventricular (AV) block (2:1 AV block, AV Mobitz I, AV Mobitz II, complete heart block) * sinus arrest \> 3 seconds in duration Or * a treatment-emergent adverse event (TEAE) per the Medical Dictionary for Regulatory Activities (MedDRA) Standardised MedDRA Queries (SMQ) (Narrow Scope) for myocardial infarction Or * a TEAE preferred term of angina unstable within 24 hours of regadenoson administration. |
| Target to Background Radiotracer Uptake Ratios From the First and Second Stress Scans | Day 1 (stress MPI 1) and Day 2 - 15 (stress MPI 2) | Image quality was assessed through radiotracer uptake in the heart (target organ) compared to liver, gut and combined liver plus gut (background interference). |
| Percentage of Scans With Subdiaphragmatic Interference | Day 1 (stress MPI 1) and Day 2 -15 (stress MPI 2) | Each reader assessed the sub-diaphragmatic radiotracer interference with cardiac image quality using a 4-point scale of 0 = none, 1 = slight, 2 = moderate or 3 = severe for each stress SPECT MPI. The median rating across the 3 readers was used to summarize the percentage of scans with interference. |
| Percentage of Cardiac Segments Obscured by Subdiaphragmatic Activity | Day 1 (stress MPI 1) and Day - 15 (stress MPI 2) | The number of cardiac segments obscured by the sub-diaphragmatic activity by group by stress SPECT MPI scan and by reader is reported. |
| Number of Participants With Adverse Events Within 24 Hours After Administration of Regadenoson | Up to 24 hours after study drug administration for each stress MPI (Day 1 and Day 2-15) | An adverse event is considered serious if, in the view of either the investigator or sponsor, it results in any of the following outcomes: * Results in death, * Is life threatening, * Results in persistent or significant disability/incapacity or substantial disruption of the ability to conduct normal life functions, * Results in congenital anomaly, or birth defect, * Requires inpatient hospitalization or leads to prolongation of hospitalization * Other medically important events. Relationship to study drug was assessed by the investigator. |
| Overall Assessment of Image Quality | Day 1 (rest MPI and stress MPI 1) and Day 2 - 15 (stress MPI 2) | The image quality for each scan was rated by each independent reader as 1 = Poor, 2 = Fair, 3 = Good, 4 = Excellent. Based on the median rating of overall image quality across the three readers, the number of participants with each rating is reported for each scan. |
Countries
Argentina, Peru, Puerto Rico, United States
Participant flow
Recruitment details
This study was conducted at 49 sites in a total of 3 countries including the United States (44 sites), Argentina (4 sites) and Peru (1 site).
Pre-assignment details
At Baseline, patients meeting all inclusion/exclusion criteria completed single photon emission computed tomography (SPECT) myocardial perfusion imaging (MPI) while at rest. Participants then underwent a Bruce or modified Bruce exercise protocol; those unable to reach 85% maximum predicted heart rate and/or 5 metabolic equivalents were randomized.
Participants by arm
| Arm | Count |
|---|---|
| Regadenoson After Peak Exercise On Day 1 participants received regadenoson, 0.4 mg in a 5 mL intravenous bolus, 3 minutes after exercise while in walk recovery and then a stress SPECT MPI. One to 14 days later participants received regadenoson at rest and then a stress SPECT MPI. | 575 |
| Regadenoson Alone On Day 1 participants received regadenoson, 0.4 mg in a 5 mL intravenous bolus, (1 hour after exercise recovery) and then stress SPECT MPI. One to 14 days later participants received regadenoson at rest and then a stress SPECT MPI. | 567 |
| Total | 1,142 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Adverse Event | 16 | 7 |
| Overall Study | Lost to Follow-up | 1 | 1 |
| Overall Study | Miscellaneous Reason | 0 | 1 |
| Overall Study | Protocol Violation | 5 | 3 |
| Overall Study | Randomized but Never Received Study Drug | 3 | 2 |
| Overall Study | Withdrawal by Subject | 9 | 9 |
Baseline characteristics
| Characteristic | Regadenoson After Peak Exercise | Regadenoson Alone | Total |
|---|---|---|---|
| Age, Continuous | 61.9 years STANDARD_DEVIATION 11.45 | 61.9 years STANDARD_DEVIATION 11.19 | 61.9 years STANDARD_DEVIATION 11.32 |
| Bruce Exercise Group Modified Bruce Exercise | 90 participants | 93 participants | 183 participants |
| Bruce Exercise Group Standard Bruce Exercise | 448 participants | 442 participants | 890 participants |
| Maximum Metabolic Equivalents Achieved | 5.45 metabolic equivalents STANDARD_DEVIATION 2.284 | 5.37 metabolic equivalents STANDARD_DEVIATION 2.331 | 5.41 metabolic equivalents STANDARD_DEVIATION 2.307 |
| Sex: Female, Male Female | 234 Participants | 239 Participants | 473 Participants |
| Sex: Female, Male Male | 341 Participants | 328 Participants | 669 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — | — / — |
| other Total, other adverse events | 277 / 575 | 274 / 544 | 307 / 567 | 290 / 548 |
| serious Total, serious adverse events | 5 / 575 | 2 / 544 | 1 / 567 | 1 / 548 |
Outcome results
Primary
Proportion of Participants With Majority Reader Self-agreement in Ischemia Assessment Between First and Second Stress Scans
SPECT scans were reviewed in a blinded fashion by 3 independent expert readers using the 17-segment model for standardized myocardial segmentation. At rest and stress, each segment was scored on a 0 (normal) to 4 (absent contrast/radiotracer uptake) scale by each of the 3 blinded readers according to the amount of contrast or radiotracer the myocardium in the segment absorbed. If the stress score was ≥ 2 and the rest score was less than the stress score, the segment was counted as having a reversible defect. The number of segments with reversible defects was categorized as absence (0 - 1 reversible segments) or presence (≥ 2 defects reversible segments) of ischemia. Each reader was defined as having self-agreement based upon identical categorization of a given participant as absent or present for ischemia for both the initial and second stress visits. Majority agreement is if at least 2 out of the 3 blinded readers demonstrated self-agreement for a given participant.
Time frame: Day 1 (rest scan and first stress scan) and Day 2 -15 (second stress scan)
Population: Full Analysis Set
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Regadenoson After Peak Exercise | Proportion of Participants With Majority Reader Self-agreement in Ischemia Assessment Between First and Second Stress Scans | 0.92 proportion of participants |
| Regadenoson Alone | Proportion of Participants With Majority Reader Self-agreement in Ischemia Assessment Between First and Second Stress Scans | 0.95 proportion of participants |
95% CI: [-0.06, 0]
Secondary
Number of Participants With Adverse Events Within 24 Hours After Administration of Regadenoson
An adverse event is considered serious if, in the view of either the investigator or sponsor, it results in any of the following outcomes: * Results in death, * Is life threatening, * Results in persistent or significant disability/incapacity or substantial disruption of the ability to conduct normal life functions, * Results in congenital anomaly, or birth defect, * Requires inpatient hospitalization or leads to prolongation of hospitalization * Other medically important events. Relationship to study drug was assessed by the investigator.
Time frame: Up to 24 hours after study drug administration for each stress MPI (Day 1 and Day 2-15)
Population: Safety Analysis Set.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Regadenoson After Peak Exercise | Number of Participants With Adverse Events Within 24 Hours After Administration of Regadenoson | Drug-related serious adverse events | 2 participants |
| Regadenoson After Peak Exercise | Number of Participants With Adverse Events Within 24 Hours After Administration of Regadenoson | Drug-related AEs leading to discontinuation | 9 participants |
| Regadenoson After Peak Exercise | Number of Participants With Adverse Events Within 24 Hours After Administration of Regadenoson | Deaths | 0 participants |
| Regadenoson After Peak Exercise | Number of Participants With Adverse Events Within 24 Hours After Administration of Regadenoson | Drug-related adverse event | 291 participants |
| Regadenoson After Peak Exercise | Number of Participants With Adverse Events Within 24 Hours After Administration of Regadenoson | Adverse events leading to discontinuation | 13 participants |
| Regadenoson After Peak Exercise | Number of Participants With Adverse Events Within 24 Hours After Administration of Regadenoson | Serious adverse events | 5 participants |
| Regadenoson After Peak Exercise | Number of Participants With Adverse Events Within 24 Hours After Administration of Regadenoson | Any adverse event | 302 participants |
| Regadenoson Alone | Number of Participants With Adverse Events Within 24 Hours After Administration of Regadenoson | Serious adverse events | 2 participants |
| Regadenoson Alone | Number of Participants With Adverse Events Within 24 Hours After Administration of Regadenoson | Drug-related serious adverse events | 0 participants |
| Regadenoson Alone | Number of Participants With Adverse Events Within 24 Hours After Administration of Regadenoson | Drug-related AEs leading to discontinuation | 0 participants |
| Regadenoson Alone | Number of Participants With Adverse Events Within 24 Hours After Administration of Regadenoson | Drug-related adverse event | 298 participants |
| Regadenoson Alone | Number of Participants With Adverse Events Within 24 Hours After Administration of Regadenoson | Any adverse event | 317 participants |
| Regadenoson Alone | Number of Participants With Adverse Events Within 24 Hours After Administration of Regadenoson | Deaths | 0 participants |
| Regadenoson Alone | Number of Participants With Adverse Events Within 24 Hours After Administration of Regadenoson | Adverse events leading to discontinuation | 0 participants |
| Regadenoson Alone: MPI 1 | Number of Participants With Adverse Events Within 24 Hours After Administration of Regadenoson | Deaths | 0 participants |
| Regadenoson Alone: MPI 1 | Number of Participants With Adverse Events Within 24 Hours After Administration of Regadenoson | Any adverse event | 329 participants |
| Regadenoson Alone: MPI 1 | Number of Participants With Adverse Events Within 24 Hours After Administration of Regadenoson | Drug-related adverse event | 319 participants |
| Regadenoson Alone: MPI 1 | Number of Participants With Adverse Events Within 24 Hours After Administration of Regadenoson | Serious adverse events | 1 participants |
| Regadenoson Alone: MPI 1 | Number of Participants With Adverse Events Within 24 Hours After Administration of Regadenoson | Drug-related serious adverse events | 0 participants |
| Regadenoson Alone: MPI 1 | Number of Participants With Adverse Events Within 24 Hours After Administration of Regadenoson | Adverse events leading to discontinuation | 5 participants |
| Regadenoson Alone: MPI 1 | Number of Participants With Adverse Events Within 24 Hours After Administration of Regadenoson | Drug-related AEs leading to discontinuation | 5 participants |
| Regadenoson Alone: MPI 2 | Number of Participants With Adverse Events Within 24 Hours After Administration of Regadenoson | Deaths | 0 participants |
| Regadenoson Alone: MPI 2 | Number of Participants With Adverse Events Within 24 Hours After Administration of Regadenoson | Drug-related AEs leading to discontinuation | 0 participants |
| Regadenoson Alone: MPI 2 | Number of Participants With Adverse Events Within 24 Hours After Administration of Regadenoson | Adverse events leading to discontinuation | 1 participants |
| Regadenoson Alone: MPI 2 | Number of Participants With Adverse Events Within 24 Hours After Administration of Regadenoson | Drug-related adverse event | 308 participants |
| Regadenoson Alone: MPI 2 | Number of Participants With Adverse Events Within 24 Hours After Administration of Regadenoson | Any adverse event | 323 participants |
| Regadenoson Alone: MPI 2 | Number of Participants With Adverse Events Within 24 Hours After Administration of Regadenoson | Drug-related serious adverse events | 0 participants |
| Regadenoson Alone: MPI 2 | Number of Participants With Adverse Events Within 24 Hours After Administration of Regadenoson | Serious adverse events | 1 participants |
Secondary
Overall Assessment of Image Quality
The image quality for each scan was rated by each independent reader as 1 = Poor, 2 = Fair, 3 = Good, 4 = Excellent. Based on the median rating of overall image quality across the three readers, the number of participants with each rating is reported for each scan.
Time frame: Day 1 (rest MPI and stress MPI 1) and Day 2 - 15 (stress MPI 2)
Population: Full Analysis Set
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Regadenoson After Peak Exercise | Overall Assessment of Image Quality | Rest MPI: Good | 307 participants |
| Regadenoson After Peak Exercise | Overall Assessment of Image Quality | Stress MPI 1: Good | 287 participants |
| Regadenoson After Peak Exercise | Overall Assessment of Image Quality | Rest MPI: Fair | 91 participants |
| Regadenoson After Peak Exercise | Overall Assessment of Image Quality | Stress MPI 1: Fair | 27 participants |
| Regadenoson After Peak Exercise | Overall Assessment of Image Quality | Rest MPI: Excellent | 140 participants |
| Regadenoson After Peak Exercise | Overall Assessment of Image Quality | Stress MPI 1: Poor | 0 participants |
| Regadenoson After Peak Exercise | Overall Assessment of Image Quality | Rest MPI: Poor | 0 participants |
| Regadenoson After Peak Exercise | Overall Assessment of Image Quality | Stress MPI 2: Excellent | 192 participants |
| Regadenoson After Peak Exercise | Overall Assessment of Image Quality | Stress MPI 2: Fair | 43 participants |
| Regadenoson After Peak Exercise | Overall Assessment of Image Quality | Stress MPI 1: Excellent | 224 participants |
| Regadenoson After Peak Exercise | Overall Assessment of Image Quality | Stress MPI 2: Poor | 0 participants |
| Regadenoson After Peak Exercise | Overall Assessment of Image Quality | Stress MPI 2: Good | 303 participants |
| Regadenoson Alone | Overall Assessment of Image Quality | Stress MPI 2: Poor | 0 participants |
| Regadenoson Alone | Overall Assessment of Image Quality | Stress MPI 2: Good | 293 participants |
| Regadenoson Alone | Overall Assessment of Image Quality | Rest MPI: Excellent | 157 participants |
| Regadenoson Alone | Overall Assessment of Image Quality | Rest MPI: Good | 308 participants |
| Regadenoson Alone | Overall Assessment of Image Quality | Rest MPI: Fair | 70 participants |
| Regadenoson Alone | Overall Assessment of Image Quality | Rest MPI: Poor | 0 participants |
| Regadenoson Alone | Overall Assessment of Image Quality | Stress MPI 1: Excellent | 211 participants |
| Regadenoson Alone | Overall Assessment of Image Quality | Stress MPI 1: Good | 291 participants |
| Regadenoson Alone | Overall Assessment of Image Quality | Stress MPI 1: Fair | 33 participants |
| Regadenoson Alone | Overall Assessment of Image Quality | Stress MPI 1: Poor | 0 participants |
| Regadenoson Alone | Overall Assessment of Image Quality | Stress MPI 2: Excellent | 205 participants |
| Regadenoson Alone | Overall Assessment of Image Quality | Stress MPI 2: Fair | 37 participants |
Secondary
Participants With Less, the Same, or More Reversible Perfusion Defects Shown by the First Stress Scan When Compared to the Second Stress Scan
Each reader evaluated the initial stress SPECT MPI scan compared to the participant's second stress SPECT MPI scan (blinded at time of the evaluation) for whether there was Less (-1), the Same (0) or More (1) reversible perfusion defects. The median assessment of the 3 blinded readers was used to summarize the number of participants in each category.
Time frame: Day 1 (stress MPI 1) and Day 2-15 (stress MPI 2)
Population: Full Analysis Set
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Regadenoson After Peak Exercise | Participants With Less, the Same, or More Reversible Perfusion Defects Shown by the First Stress Scan When Compared to the Second Stress Scan | Same Number of Reversible Perfusion Defects | 441 participants |
| Regadenoson After Peak Exercise | Participants With Less, the Same, or More Reversible Perfusion Defects Shown by the First Stress Scan When Compared to the Second Stress Scan | Less Reversible Perfusion Defects | 57 participants |
| Regadenoson After Peak Exercise | Participants With Less, the Same, or More Reversible Perfusion Defects Shown by the First Stress Scan When Compared to the Second Stress Scan | More Reversible Perfusion Defects | 40 participants |
| Regadenoson Alone | Participants With Less, the Same, or More Reversible Perfusion Defects Shown by the First Stress Scan When Compared to the Second Stress Scan | Same Number of Reversible Perfusion Defects | 459 participants |
| Regadenoson Alone | Participants With Less, the Same, or More Reversible Perfusion Defects Shown by the First Stress Scan When Compared to the Second Stress Scan | Less Reversible Perfusion Defects | 49 participants |
| Regadenoson Alone | Participants With Less, the Same, or More Reversible Perfusion Defects Shown by the First Stress Scan When Compared to the Second Stress Scan | More Reversible Perfusion Defects | 27 participants |
Secondary
Percentage of Cardiac Segments Obscured by Subdiaphragmatic Activity
The number of cardiac segments obscured by the sub-diaphragmatic activity by group by stress SPECT MPI scan and by reader is reported.
Time frame: Day 1 (stress MPI 1) and Day - 15 (stress MPI 2)
Population: Full Analysis Set
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Regadenoson After Peak Exercise | Percentage of Cardiac Segments Obscured by Subdiaphragmatic Activity | Reader 2: Segment 12 | 0.0 percentage of segments |
| Regadenoson After Peak Exercise | Percentage of Cardiac Segments Obscured by Subdiaphragmatic Activity | Reader 1: Segment 5 | 9.7 percentage of segments |
| Regadenoson After Peak Exercise | Percentage of Cardiac Segments Obscured by Subdiaphragmatic Activity | Reader 1: Segment 17 | 0.0 percentage of segments |
| Regadenoson After Peak Exercise | Percentage of Cardiac Segments Obscured by Subdiaphragmatic Activity | Reader 1: Segment 6 | 0.0 percentage of segments |
| Regadenoson After Peak Exercise | Percentage of Cardiac Segments Obscured by Subdiaphragmatic Activity | Reader 3: Segment 2 | 0.0 percentage of segments |
| Regadenoson After Peak Exercise | Percentage of Cardiac Segments Obscured by Subdiaphragmatic Activity | Reader 1: Segment 7 | 0.0 percentage of segments |
| Regadenoson After Peak Exercise | Percentage of Cardiac Segments Obscured by Subdiaphragmatic Activity | Reader 1: Segment 16 | 0.0 percentage of segments |
| Regadenoson After Peak Exercise | Percentage of Cardiac Segments Obscured by Subdiaphragmatic Activity | Reader 1: Segment 8 | 0.0 percentage of segments |
| Regadenoson After Peak Exercise | Percentage of Cardiac Segments Obscured by Subdiaphragmatic Activity | Reader 1: Segment 9 | 0.0 percentage of segments |
| Regadenoson After Peak Exercise | Percentage of Cardiac Segments Obscured by Subdiaphragmatic Activity | Reader 2: Segment 14 | 0.0 percentage of segments |
| Regadenoson After Peak Exercise | Percentage of Cardiac Segments Obscured by Subdiaphragmatic Activity | Reader 1: Segment 15 | 1.7 percentage of segments |
| Regadenoson After Peak Exercise | Percentage of Cardiac Segments Obscured by Subdiaphragmatic Activity | Reader 1: Segment 10 | 31.6 percentage of segments |
| Regadenoson After Peak Exercise | Percentage of Cardiac Segments Obscured by Subdiaphragmatic Activity | Reader 2: Segment 9 | 0.0 percentage of segments |
| Regadenoson After Peak Exercise | Percentage of Cardiac Segments Obscured by Subdiaphragmatic Activity | Reader 1: Segment 11 | 9.5 percentage of segments |
| Regadenoson After Peak Exercise | Percentage of Cardiac Segments Obscured by Subdiaphragmatic Activity | Reader 3: Segment 4 | 14.1 percentage of segments |
| Regadenoson After Peak Exercise | Percentage of Cardiac Segments Obscured by Subdiaphragmatic Activity | Reader 1: Segment 14 | 0.0 percentage of segments |
| Regadenoson After Peak Exercise | Percentage of Cardiac Segments Obscured by Subdiaphragmatic Activity | Reader 1: Segment 12 | 0.0 percentage of segments |
| Regadenoson After Peak Exercise | Percentage of Cardiac Segments Obscured by Subdiaphragmatic Activity | Reader 1: Segment 13 | 0.0 percentage of segments |
| Regadenoson After Peak Exercise | Percentage of Cardiac Segments Obscured by Subdiaphragmatic Activity | Reader 3: Segment 5 | 0.6 percentage of segments |
| Regadenoson After Peak Exercise | Percentage of Cardiac Segments Obscured by Subdiaphragmatic Activity | Reader 2: Segment 8 | 0.0 percentage of segments |
| Regadenoson After Peak Exercise | Percentage of Cardiac Segments Obscured by Subdiaphragmatic Activity | Reader 3: Segment 6 | 0.0 percentage of segments |
| Regadenoson After Peak Exercise | Percentage of Cardiac Segments Obscured by Subdiaphragmatic Activity | Reader 3: Segment 7 | 0.0 percentage of segments |
| Regadenoson After Peak Exercise | Percentage of Cardiac Segments Obscured by Subdiaphragmatic Activity | Reader 2: Segment 15 | 9.1 percentage of segments |
| Regadenoson After Peak Exercise | Percentage of Cardiac Segments Obscured by Subdiaphragmatic Activity | Reader 2: Segment 7 | 0.0 percentage of segments |
| Regadenoson After Peak Exercise | Percentage of Cardiac Segments Obscured by Subdiaphragmatic Activity | Reader 3: Segment 8 | 0.0 percentage of segments |
| Regadenoson After Peak Exercise | Percentage of Cardiac Segments Obscured by Subdiaphragmatic Activity | Reader 2: Segment 13 | 0.0 percentage of segments |
| Regadenoson After Peak Exercise | Percentage of Cardiac Segments Obscured by Subdiaphragmatic Activity | Reader 3: Segment 9 | 0.0 percentage of segments |
| Regadenoson After Peak Exercise | Percentage of Cardiac Segments Obscured by Subdiaphragmatic Activity | Reader 2: Segment 6 | 0.0 percentage of segments |
| Regadenoson After Peak Exercise | Percentage of Cardiac Segments Obscured by Subdiaphragmatic Activity | Reader 3: Segment 10 | 16.0 percentage of segments |
| Regadenoson After Peak Exercise | Percentage of Cardiac Segments Obscured by Subdiaphragmatic Activity | Reader 3: Segment 3 | 0.0 percentage of segments |
| Regadenoson After Peak Exercise | Percentage of Cardiac Segments Obscured by Subdiaphragmatic Activity | Reader 3: Segment 11 | 0.7 percentage of segments |
| Regadenoson After Peak Exercise | Percentage of Cardiac Segments Obscured by Subdiaphragmatic Activity | Reader 2: Segment 11 | 0.0 percentage of segments |
| Regadenoson After Peak Exercise | Percentage of Cardiac Segments Obscured by Subdiaphragmatic Activity | Reader 2: Segment 5 | 1.1 percentage of segments |
| Regadenoson After Peak Exercise | Percentage of Cardiac Segments Obscured by Subdiaphragmatic Activity | Reader 3: Segment 12 | 0.0 percentage of segments |
| Regadenoson After Peak Exercise | Percentage of Cardiac Segments Obscured by Subdiaphragmatic Activity | Reader 2: Segment 16 | 0.0 percentage of segments |
| Regadenoson After Peak Exercise | Percentage of Cardiac Segments Obscured by Subdiaphragmatic Activity | Reader 3: Segment 13 | 0.2 percentage of segments |
| Regadenoson After Peak Exercise | Percentage of Cardiac Segments Obscured by Subdiaphragmatic Activity | Reader 2: Segment 4 | 34.4 percentage of segments |
| Regadenoson After Peak Exercise | Percentage of Cardiac Segments Obscured by Subdiaphragmatic Activity | Reader 3: Segment 14 | 0.0 percentage of segments |
| Regadenoson After Peak Exercise | Percentage of Cardiac Segments Obscured by Subdiaphragmatic Activity | Reader 3: Segment 15 | 13.9 percentage of segments |
| Regadenoson After Peak Exercise | Percentage of Cardiac Segments Obscured by Subdiaphragmatic Activity | Reader 2: Segment 17 | 0.4 percentage of segments |
| Regadenoson After Peak Exercise | Percentage of Cardiac Segments Obscured by Subdiaphragmatic Activity | Reader 2: Segment 3 | 0.0 percentage of segments |
| Regadenoson After Peak Exercise | Percentage of Cardiac Segments Obscured by Subdiaphragmatic Activity | Reader 3: Segment 16 | 0.4 percentage of segments |
| Regadenoson After Peak Exercise | Percentage of Cardiac Segments Obscured by Subdiaphragmatic Activity | Reader 3: Segment 17 | 0.9 percentage of segments |
| Regadenoson After Peak Exercise | Percentage of Cardiac Segments Obscured by Subdiaphragmatic Activity | Reader 1: Segment 1 | 0.0 percentage of segments |
| Regadenoson After Peak Exercise | Percentage of Cardiac Segments Obscured by Subdiaphragmatic Activity | Reader 2: Segment 10 | 12.6 percentage of segments |
| Regadenoson After Peak Exercise | Percentage of Cardiac Segments Obscured by Subdiaphragmatic Activity | Reader 2: Segment 2 | 0.0 percentage of segments |
| Regadenoson After Peak Exercise | Percentage of Cardiac Segments Obscured by Subdiaphragmatic Activity | Reader 1: Segment 2 | 0.0 percentage of segments |
| Regadenoson After Peak Exercise | Percentage of Cardiac Segments Obscured by Subdiaphragmatic Activity | Reader 3: Segment 1 | 0.0 percentage of segments |
| Regadenoson After Peak Exercise | Percentage of Cardiac Segments Obscured by Subdiaphragmatic Activity | Reader 1: Segment 3 | 0.0 percentage of segments |
| Regadenoson After Peak Exercise | Percentage of Cardiac Segments Obscured by Subdiaphragmatic Activity | Reader 2: Segment 1 | 0.0 percentage of segments |
| Regadenoson After Peak Exercise | Percentage of Cardiac Segments Obscured by Subdiaphragmatic Activity | Reader 1: Segment 4 | 33.6 percentage of segments |
| Regadenoson Alone | Percentage of Cardiac Segments Obscured by Subdiaphragmatic Activity | Reader 2: Segment 6 | 0.0 percentage of segments |
| Regadenoson Alone | Percentage of Cardiac Segments Obscured by Subdiaphragmatic Activity | Reader 3: Segment 15 | 13.8 percentage of segments |
| Regadenoson Alone | Percentage of Cardiac Segments Obscured by Subdiaphragmatic Activity | Reader 1: Segment 5 | 8.4 percentage of segments |
| Regadenoson Alone | Percentage of Cardiac Segments Obscured by Subdiaphragmatic Activity | Reader 2: Segment 9 | 0.0 percentage of segments |
| Regadenoson Alone | Percentage of Cardiac Segments Obscured by Subdiaphragmatic Activity | Reader 3: Segment 9 | 0.0 percentage of segments |
| Regadenoson Alone | Percentage of Cardiac Segments Obscured by Subdiaphragmatic Activity | Reader 2: Segment 15 | 8.7 percentage of segments |
| Regadenoson Alone | Percentage of Cardiac Segments Obscured by Subdiaphragmatic Activity | Reader 1: Segment 6 | 0.0 percentage of segments |
| Regadenoson Alone | Percentage of Cardiac Segments Obscured by Subdiaphragmatic Activity | Reader 1: Segment 3 | 0.0 percentage of segments |
| Regadenoson Alone | Percentage of Cardiac Segments Obscured by Subdiaphragmatic Activity | Reader 1: Segment 16 | 0.0 percentage of segments |
| Regadenoson Alone | Percentage of Cardiac Segments Obscured by Subdiaphragmatic Activity | Reader 3: Segment 1 | 0.2 percentage of segments |
| Regadenoson Alone | Percentage of Cardiac Segments Obscured by Subdiaphragmatic Activity | Reader 1: Segment 7 | 0.0 percentage of segments |
| Regadenoson Alone | Percentage of Cardiac Segments Obscured by Subdiaphragmatic Activity | Reader 3: Segment 2 | 0.0 percentage of segments |
| Regadenoson Alone | Percentage of Cardiac Segments Obscured by Subdiaphragmatic Activity | Reader 3: Segment 10 | 17.8 percentage of segments |
| Regadenoson Alone | Percentage of Cardiac Segments Obscured by Subdiaphragmatic Activity | Reader 1: Segment 2 | 0.0 percentage of segments |
| Regadenoson Alone | Percentage of Cardiac Segments Obscured by Subdiaphragmatic Activity | Reader 1: Segment 8 | 0.0 percentage of segments |
| Regadenoson Alone | Percentage of Cardiac Segments Obscured by Subdiaphragmatic Activity | Reader 2: Segment 13 | 0.0 percentage of segments |
| Regadenoson Alone | Percentage of Cardiac Segments Obscured by Subdiaphragmatic Activity | Reader 1: Segment 15 | 0.9 percentage of segments |
| Regadenoson Alone | Percentage of Cardiac Segments Obscured by Subdiaphragmatic Activity | Reader 2: Segment 5 | 0.4 percentage of segments |
| Regadenoson Alone | Percentage of Cardiac Segments Obscured by Subdiaphragmatic Activity | Reader 1: Segment 9 | 0.0 percentage of segments |
| Regadenoson Alone | Percentage of Cardiac Segments Obscured by Subdiaphragmatic Activity | Reader 3: Segment 16 | 0.7 percentage of segments |
| Regadenoson Alone | Percentage of Cardiac Segments Obscured by Subdiaphragmatic Activity | Reader 3: Segment 11 | 0.2 percentage of segments |
| Regadenoson Alone | Percentage of Cardiac Segments Obscured by Subdiaphragmatic Activity | Reader 2: Segment 17 | 0.0 percentage of segments |
| Regadenoson Alone | Percentage of Cardiac Segments Obscured by Subdiaphragmatic Activity | Reader 1: Segment 10 | 35.5 percentage of segments |
| Regadenoson Alone | Percentage of Cardiac Segments Obscured by Subdiaphragmatic Activity | Reader 2: Segment 2 | 0.0 percentage of segments |
| Regadenoson Alone | Percentage of Cardiac Segments Obscured by Subdiaphragmatic Activity | Reader 1: Segment 14 | 0.0 percentage of segments |
| Regadenoson Alone | Percentage of Cardiac Segments Obscured by Subdiaphragmatic Activity | Reader 1: Segment 4 | 37.2 percentage of segments |
| Regadenoson Alone | Percentage of Cardiac Segments Obscured by Subdiaphragmatic Activity | Reader 1: Segment 11 | 8.2 percentage of segments |
| Regadenoson Alone | Percentage of Cardiac Segments Obscured by Subdiaphragmatic Activity | Reader 3: Segment 12 | 0.0 percentage of segments |
| Regadenoson Alone | Percentage of Cardiac Segments Obscured by Subdiaphragmatic Activity | Reader 3: Segment 17 | 0.9 percentage of segments |
| Regadenoson Alone | Percentage of Cardiac Segments Obscured by Subdiaphragmatic Activity | Reader 2: Segment 4 | 35.1 percentage of segments |
| Regadenoson Alone | Percentage of Cardiac Segments Obscured by Subdiaphragmatic Activity | Reader 1: Segment 12 | 0.0 percentage of segments |
| Regadenoson Alone | Percentage of Cardiac Segments Obscured by Subdiaphragmatic Activity | Reader 3: Segment 4 | 16.7 percentage of segments |
| Regadenoson Alone | Percentage of Cardiac Segments Obscured by Subdiaphragmatic Activity | Reader 1: Segment 13 | 0.0 percentage of segments |
| Regadenoson Alone | Percentage of Cardiac Segments Obscured by Subdiaphragmatic Activity | Reader 3: Segment 3 | 0.0 percentage of segments |
| Regadenoson Alone | Percentage of Cardiac Segments Obscured by Subdiaphragmatic Activity | Reader 2: Segment 14 | 0.0 percentage of segments |
| Regadenoson Alone | Percentage of Cardiac Segments Obscured by Subdiaphragmatic Activity | Reader 2: Segment 8 | 0.2 percentage of segments |
| Regadenoson Alone | Percentage of Cardiac Segments Obscured by Subdiaphragmatic Activity | Reader 3: Segment 13 | 0.0 percentage of segments |
| Regadenoson Alone | Percentage of Cardiac Segments Obscured by Subdiaphragmatic Activity | Reader 3: Segment 5 | 0.4 percentage of segments |
| Regadenoson Alone | Percentage of Cardiac Segments Obscured by Subdiaphragmatic Activity | Reader 2: Segment 12 | 0.0 percentage of segments |
| Regadenoson Alone | Percentage of Cardiac Segments Obscured by Subdiaphragmatic Activity | Reader 2: Segment 16 | 0.2 percentage of segments |
| Regadenoson Alone | Percentage of Cardiac Segments Obscured by Subdiaphragmatic Activity | Reader 2: Segment 1 | 0.0 percentage of segments |
| Regadenoson Alone | Percentage of Cardiac Segments Obscured by Subdiaphragmatic Activity | Reader 3: Segment 6 | 0.0 percentage of segments |
| Regadenoson Alone | Percentage of Cardiac Segments Obscured by Subdiaphragmatic Activity | Reader 2: Segment 11 | 0.2 percentage of segments |
| Regadenoson Alone | Percentage of Cardiac Segments Obscured by Subdiaphragmatic Activity | Reader 2: Segment 7 | 0.0 percentage of segments |
| Regadenoson Alone | Percentage of Cardiac Segments Obscured by Subdiaphragmatic Activity | Reader 1: Segment 1 | 0.0 percentage of segments |
| Regadenoson Alone | Percentage of Cardiac Segments Obscured by Subdiaphragmatic Activity | Reader 3: Segment 7 | 0.0 percentage of segments |
| Regadenoson Alone | Percentage of Cardiac Segments Obscured by Subdiaphragmatic Activity | Reader 3: Segment 14 | 0.0 percentage of segments |
| Regadenoson Alone | Percentage of Cardiac Segments Obscured by Subdiaphragmatic Activity | Reader 2: Segment 10 | 11.9 percentage of segments |
| Regadenoson Alone | Percentage of Cardiac Segments Obscured by Subdiaphragmatic Activity | Reader 2: Segment 3 | 0.0 percentage of segments |
| Regadenoson Alone | Percentage of Cardiac Segments Obscured by Subdiaphragmatic Activity | Reader 3: Segment 8 | 0.0 percentage of segments |
| Regadenoson Alone | Percentage of Cardiac Segments Obscured by Subdiaphragmatic Activity | Reader 1: Segment 17 | 0.0 percentage of segments |
| Regadenoson Alone: MPI 1 | Percentage of Cardiac Segments Obscured by Subdiaphragmatic Activity | Reader 3: Segment 8 | 0.0 percentage of segments |
| Regadenoson Alone: MPI 1 | Percentage of Cardiac Segments Obscured by Subdiaphragmatic Activity | Reader 2: Segment 13 | 0.0 percentage of segments |
| Regadenoson Alone: MPI 1 | Percentage of Cardiac Segments Obscured by Subdiaphragmatic Activity | Reader 2: Segment 16 | 0.0 percentage of segments |
| Regadenoson Alone: MPI 1 | Percentage of Cardiac Segments Obscured by Subdiaphragmatic Activity | Reader 2: Segment 14 | 0.0 percentage of segments |
| Regadenoson Alone: MPI 1 | Percentage of Cardiac Segments Obscured by Subdiaphragmatic Activity | Reader 2: Segment 15 | 10.5 percentage of segments |
| Regadenoson Alone: MPI 1 | Percentage of Cardiac Segments Obscured by Subdiaphragmatic Activity | Reader 2: Segment 17 | 0.0 percentage of segments |
| Regadenoson Alone: MPI 1 | Percentage of Cardiac Segments Obscured by Subdiaphragmatic Activity | Reader 3: Segment 1 | 0.0 percentage of segments |
| Regadenoson Alone: MPI 1 | Percentage of Cardiac Segments Obscured by Subdiaphragmatic Activity | Reader 3: Segment 2 | 0.0 percentage of segments |
| Regadenoson Alone: MPI 1 | Percentage of Cardiac Segments Obscured by Subdiaphragmatic Activity | Reader 3: Segment 3 | 0.0 percentage of segments |
| Regadenoson Alone: MPI 1 | Percentage of Cardiac Segments Obscured by Subdiaphragmatic Activity | Reader 3: Segment 4 | 17.9 percentage of segments |
| Regadenoson Alone: MPI 1 | Percentage of Cardiac Segments Obscured by Subdiaphragmatic Activity | Reader 3: Segment 5 | 0.7 percentage of segments |
| Regadenoson Alone: MPI 1 | Percentage of Cardiac Segments Obscured by Subdiaphragmatic Activity | Reader 3: Segment 6 | 0.0 percentage of segments |
| Regadenoson Alone: MPI 1 | Percentage of Cardiac Segments Obscured by Subdiaphragmatic Activity | Reader 3: Segment 7 | 0.0 percentage of segments |
| Regadenoson Alone: MPI 1 | Percentage of Cardiac Segments Obscured by Subdiaphragmatic Activity | Reader 3: Segment 9 | 0.0 percentage of segments |
| Regadenoson Alone: MPI 1 | Percentage of Cardiac Segments Obscured by Subdiaphragmatic Activity | Reader 3: Segment 10 | 18.5 percentage of segments |
| Regadenoson Alone: MPI 1 | Percentage of Cardiac Segments Obscured by Subdiaphragmatic Activity | Reader 3: Segment 11 | 0.6 percentage of segments |
| Regadenoson Alone: MPI 1 | Percentage of Cardiac Segments Obscured by Subdiaphragmatic Activity | Reader 3: Segment 12 | 0.0 percentage of segments |
| Regadenoson Alone: MPI 1 | Percentage of Cardiac Segments Obscured by Subdiaphragmatic Activity | Reader 3: Segment 13 | 0.0 percentage of segments |
| Regadenoson Alone: MPI 1 | Percentage of Cardiac Segments Obscured by Subdiaphragmatic Activity | Reader 3: Segment 14 | 0.0 percentage of segments |
| Regadenoson Alone: MPI 1 | Percentage of Cardiac Segments Obscured by Subdiaphragmatic Activity | Reader 3: Segment 15 | 13.1 percentage of segments |
| Regadenoson Alone: MPI 1 | Percentage of Cardiac Segments Obscured by Subdiaphragmatic Activity | Reader 3: Segment 16 | 0.4 percentage of segments |
| Regadenoson Alone: MPI 1 | Percentage of Cardiac Segments Obscured by Subdiaphragmatic Activity | Reader 3: Segment 17 | 0.7 percentage of segments |
| Regadenoson Alone: MPI 1 | Percentage of Cardiac Segments Obscured by Subdiaphragmatic Activity | Reader 1: Segment 1 | 0.0 percentage of segments |
| Regadenoson Alone: MPI 1 | Percentage of Cardiac Segments Obscured by Subdiaphragmatic Activity | Reader 1: Segment 2 | 0.0 percentage of segments |
| Regadenoson Alone: MPI 1 | Percentage of Cardiac Segments Obscured by Subdiaphragmatic Activity | Reader 1: Segment 3 | 0.0 percentage of segments |
| Regadenoson Alone: MPI 1 | Percentage of Cardiac Segments Obscured by Subdiaphragmatic Activity | Reader 1: Segment 4 | 34.2 percentage of segments |
| Regadenoson Alone: MPI 1 | Percentage of Cardiac Segments Obscured by Subdiaphragmatic Activity | Reader 1: Segment 5 | 7.9 percentage of segments |
| Regadenoson Alone: MPI 1 | Percentage of Cardiac Segments Obscured by Subdiaphragmatic Activity | Reader 1: Segment 6 | 0.0 percentage of segments |
| Regadenoson Alone: MPI 1 | Percentage of Cardiac Segments Obscured by Subdiaphragmatic Activity | Reader 1: Segment 7 | 0.0 percentage of segments |
| Regadenoson Alone: MPI 1 | Percentage of Cardiac Segments Obscured by Subdiaphragmatic Activity | Reader 1: Segment 8 | 0.0 percentage of segments |
| Regadenoson Alone: MPI 1 | Percentage of Cardiac Segments Obscured by Subdiaphragmatic Activity | Reader 1: Segment 9 | 0.0 percentage of segments |
| Regadenoson Alone: MPI 1 | Percentage of Cardiac Segments Obscured by Subdiaphragmatic Activity | Reader 1: Segment 10 | 32.3 percentage of segments |
| Regadenoson Alone: MPI 1 | Percentage of Cardiac Segments Obscured by Subdiaphragmatic Activity | Reader 1: Segment 11 | 7.5 percentage of segments |
| Regadenoson Alone: MPI 1 | Percentage of Cardiac Segments Obscured by Subdiaphragmatic Activity | Reader 1: Segment 12 | 0.0 percentage of segments |
| Regadenoson Alone: MPI 1 | Percentage of Cardiac Segments Obscured by Subdiaphragmatic Activity | Reader 1: Segment 13 | 0.0 percentage of segments |
| Regadenoson Alone: MPI 1 | Percentage of Cardiac Segments Obscured by Subdiaphragmatic Activity | Reader 1: Segment 14 | 0.0 percentage of segments |
| Regadenoson Alone: MPI 1 | Percentage of Cardiac Segments Obscured by Subdiaphragmatic Activity | Reader 1: Segment 15 | 2.4 percentage of segments |
| Regadenoson Alone: MPI 1 | Percentage of Cardiac Segments Obscured by Subdiaphragmatic Activity | Reader 1: Segment 16 | 0.2 percentage of segments |
| Regadenoson Alone: MPI 1 | Percentage of Cardiac Segments Obscured by Subdiaphragmatic Activity | Reader 1: Segment 17 | 0.0 percentage of segments |
| Regadenoson Alone: MPI 1 | Percentage of Cardiac Segments Obscured by Subdiaphragmatic Activity | Reader 2: Segment 1 | 0.0 percentage of segments |
| Regadenoson Alone: MPI 1 | Percentage of Cardiac Segments Obscured by Subdiaphragmatic Activity | Reader 2: Segment 2 | 0.2 percentage of segments |
| Regadenoson Alone: MPI 1 | Percentage of Cardiac Segments Obscured by Subdiaphragmatic Activity | Reader 2: Segment 3 | 0.2 percentage of segments |
| Regadenoson Alone: MPI 1 | Percentage of Cardiac Segments Obscured by Subdiaphragmatic Activity | Reader 2: Segment 4 | 32.5 percentage of segments |
| Regadenoson Alone: MPI 1 | Percentage of Cardiac Segments Obscured by Subdiaphragmatic Activity | Reader 2: Segment 5 | 0.7 percentage of segments |
| Regadenoson Alone: MPI 1 | Percentage of Cardiac Segments Obscured by Subdiaphragmatic Activity | Reader 2: Segment 6 | 0.0 percentage of segments |
| Regadenoson Alone: MPI 1 | Percentage of Cardiac Segments Obscured by Subdiaphragmatic Activity | Reader 2: Segment 7 | 0.0 percentage of segments |
| Regadenoson Alone: MPI 1 | Percentage of Cardiac Segments Obscured by Subdiaphragmatic Activity | Reader 2: Segment 8 | 0.0 percentage of segments |
| Regadenoson Alone: MPI 1 | Percentage of Cardiac Segments Obscured by Subdiaphragmatic Activity | Reader 2: Segment 9 | 0.4 percentage of segments |
| Regadenoson Alone: MPI 1 | Percentage of Cardiac Segments Obscured by Subdiaphragmatic Activity | Reader 2: Segment 10 | 13.8 percentage of segments |
| Regadenoson Alone: MPI 1 | Percentage of Cardiac Segments Obscured by Subdiaphragmatic Activity | Reader 2: Segment 11 | 0.6 percentage of segments |
| Regadenoson Alone: MPI 1 | Percentage of Cardiac Segments Obscured by Subdiaphragmatic Activity | Reader 2: Segment 12 | 0.0 percentage of segments |
| Regadenoson Alone: MPI 2 | Percentage of Cardiac Segments Obscured by Subdiaphragmatic Activity | Reader 2: Segment 17 | 0.0 percentage of segments |
| Regadenoson Alone: MPI 2 | Percentage of Cardiac Segments Obscured by Subdiaphragmatic Activity | Reader 1: Segment 17 | 0.0 percentage of segments |
| Regadenoson Alone: MPI 2 | Percentage of Cardiac Segments Obscured by Subdiaphragmatic Activity | Reader 1: Segment 3 | 0.0 percentage of segments |
| Regadenoson Alone: MPI 2 | Percentage of Cardiac Segments Obscured by Subdiaphragmatic Activity | Reader 1: Segment 2 | 0.0 percentage of segments |
| Regadenoson Alone: MPI 2 | Percentage of Cardiac Segments Obscured by Subdiaphragmatic Activity | Reader 2: Segment 16 | 0.0 percentage of segments |
| Regadenoson Alone: MPI 2 | Percentage of Cardiac Segments Obscured by Subdiaphragmatic Activity | Reader 2: Segment 1 | 0.0 percentage of segments |
| Regadenoson Alone: MPI 2 | Percentage of Cardiac Segments Obscured by Subdiaphragmatic Activity | Reader 1: Segment 1 | 0.0 percentage of segments |
| Regadenoson Alone: MPI 2 | Percentage of Cardiac Segments Obscured by Subdiaphragmatic Activity | Reader 3: Segment 16 | 0.2 percentage of segments |
| Regadenoson Alone: MPI 2 | Percentage of Cardiac Segments Obscured by Subdiaphragmatic Activity | Reader 2: Segment 13 | 0.0 percentage of segments |
| Regadenoson Alone: MPI 2 | Percentage of Cardiac Segments Obscured by Subdiaphragmatic Activity | Reader 2: Segment 2 | 0.0 percentage of segments |
| Regadenoson Alone: MPI 2 | Percentage of Cardiac Segments Obscured by Subdiaphragmatic Activity | Reader 3: Segment 15 | 14.6 percentage of segments |
| Regadenoson Alone: MPI 2 | Percentage of Cardiac Segments Obscured by Subdiaphragmatic Activity | Reader 3: Segment 14 | 0.0 percentage of segments |
| Regadenoson Alone: MPI 2 | Percentage of Cardiac Segments Obscured by Subdiaphragmatic Activity | Reader 2: Segment 10 | 13.1 percentage of segments |
| Regadenoson Alone: MPI 2 | Percentage of Cardiac Segments Obscured by Subdiaphragmatic Activity | Reader 2: Segment 3 | 0.6 percentage of segments |
| Regadenoson Alone: MPI 2 | Percentage of Cardiac Segments Obscured by Subdiaphragmatic Activity | Reader 3: Segment 13 | 0.0 percentage of segments |
| Regadenoson Alone: MPI 2 | Percentage of Cardiac Segments Obscured by Subdiaphragmatic Activity | Reader 3: Segment 12 | 0.0 percentage of segments |
| Regadenoson Alone: MPI 2 | Percentage of Cardiac Segments Obscured by Subdiaphragmatic Activity | Reader 2: Segment 15 | 9.5 percentage of segments |
| Regadenoson Alone: MPI 2 | Percentage of Cardiac Segments Obscured by Subdiaphragmatic Activity | Reader 2: Segment 4 | 32.5 percentage of segments |
| Regadenoson Alone: MPI 2 | Percentage of Cardiac Segments Obscured by Subdiaphragmatic Activity | Reader 3: Segment 11 | 0.2 percentage of segments |
| Regadenoson Alone: MPI 2 | Percentage of Cardiac Segments Obscured by Subdiaphragmatic Activity | Reader 3: Segment 10 | 18.9 percentage of segments |
| Regadenoson Alone: MPI 2 | Percentage of Cardiac Segments Obscured by Subdiaphragmatic Activity | Reader 2: Segment 14 | 0.0 percentage of segments |
| Regadenoson Alone: MPI 2 | Percentage of Cardiac Segments Obscured by Subdiaphragmatic Activity | Reader 2: Segment 5 | 0.7 percentage of segments |
| Regadenoson Alone: MPI 2 | Percentage of Cardiac Segments Obscured by Subdiaphragmatic Activity | Reader 3: Segment 9 | 0.0 percentage of segments |
| Regadenoson Alone: MPI 2 | Percentage of Cardiac Segments Obscured by Subdiaphragmatic Activity | Reader 3: Segment 8 | 0.0 percentage of segments |
| Regadenoson Alone: MPI 2 | Percentage of Cardiac Segments Obscured by Subdiaphragmatic Activity | Reader 2: Segment 12 | 0.0 percentage of segments |
| Regadenoson Alone: MPI 2 | Percentage of Cardiac Segments Obscured by Subdiaphragmatic Activity | Reader 2: Segment 6 | 0.0 percentage of segments |
| Regadenoson Alone: MPI 2 | Percentage of Cardiac Segments Obscured by Subdiaphragmatic Activity | Reader 3: Segment 7 | 0.0 percentage of segments |
| Regadenoson Alone: MPI 2 | Percentage of Cardiac Segments Obscured by Subdiaphragmatic Activity | Reader 3: Segment 6 | 0.0 percentage of segments |
| Regadenoson Alone: MPI 2 | Percentage of Cardiac Segments Obscured by Subdiaphragmatic Activity | Reader 2: Segment 11 | 0.2 percentage of segments |
| Regadenoson Alone: MPI 2 | Percentage of Cardiac Segments Obscured by Subdiaphragmatic Activity | Reader 2: Segment 7 | 0.0 percentage of segments |
| Regadenoson Alone: MPI 2 | Percentage of Cardiac Segments Obscured by Subdiaphragmatic Activity | Reader 3: Segment 5 | 0.2 percentage of segments |
| Regadenoson Alone: MPI 2 | Percentage of Cardiac Segments Obscured by Subdiaphragmatic Activity | Reader 3: Segment 4 | 17.2 percentage of segments |
| Regadenoson Alone: MPI 2 | Percentage of Cardiac Segments Obscured by Subdiaphragmatic Activity | Reader 3: Segment 17 | 0.6 percentage of segments |
| Regadenoson Alone: MPI 2 | Percentage of Cardiac Segments Obscured by Subdiaphragmatic Activity | Reader 2: Segment 8 | 0.0 percentage of segments |
| Regadenoson Alone: MPI 2 | Percentage of Cardiac Segments Obscured by Subdiaphragmatic Activity | Reader 1: Segment 12 | 0.0 percentage of segments |
| Regadenoson Alone: MPI 2 | Percentage of Cardiac Segments Obscured by Subdiaphragmatic Activity | Reader 3: Segment 3 | 0.0 percentage of segments |
| Regadenoson Alone: MPI 2 | Percentage of Cardiac Segments Obscured by Subdiaphragmatic Activity | Reader 1: Segment 13 | 0.0 percentage of segments |
| Regadenoson Alone: MPI 2 | Percentage of Cardiac Segments Obscured by Subdiaphragmatic Activity | Reader 1: Segment 11 | 7.5 percentage of segments |
| Regadenoson Alone: MPI 2 | Percentage of Cardiac Segments Obscured by Subdiaphragmatic Activity | Reader 1: Segment 10 | 36.3 percentage of segments |
| Regadenoson Alone: MPI 2 | Percentage of Cardiac Segments Obscured by Subdiaphragmatic Activity | Reader 3: Segment 1 | 0.0 percentage of segments |
| Regadenoson Alone: MPI 2 | Percentage of Cardiac Segments Obscured by Subdiaphragmatic Activity | Reader 1: Segment 14 | 0.0 percentage of segments |
| Regadenoson Alone: MPI 2 | Percentage of Cardiac Segments Obscured by Subdiaphragmatic Activity | Reader 1: Segment 9 | 0.0 percentage of segments |
| Regadenoson Alone: MPI 2 | Percentage of Cardiac Segments Obscured by Subdiaphragmatic Activity | Reader 1: Segment 8 | 0.0 percentage of segments |
| Regadenoson Alone: MPI 2 | Percentage of Cardiac Segments Obscured by Subdiaphragmatic Activity | Reader 3: Segment 2 | 0.0 percentage of segments |
| Regadenoson Alone: MPI 2 | Percentage of Cardiac Segments Obscured by Subdiaphragmatic Activity | Reader 1: Segment 15 | 2.1 percentage of segments |
| Regadenoson Alone: MPI 2 | Percentage of Cardiac Segments Obscured by Subdiaphragmatic Activity | Reader 1: Segment 7 | 0.0 percentage of segments |
| Regadenoson Alone: MPI 2 | Percentage of Cardiac Segments Obscured by Subdiaphragmatic Activity | Reader 1: Segment 6 | 0.0 percentage of segments |
| Regadenoson Alone: MPI 2 | Percentage of Cardiac Segments Obscured by Subdiaphragmatic Activity | Reader 2: Segment 9 | 0.4 percentage of segments |
| Regadenoson Alone: MPI 2 | Percentage of Cardiac Segments Obscured by Subdiaphragmatic Activity | Reader 1: Segment 16 | 0.2 percentage of segments |
| Regadenoson Alone: MPI 2 | Percentage of Cardiac Segments Obscured by Subdiaphragmatic Activity | Reader 1: Segment 5 | 7.7 percentage of segments |
| Regadenoson Alone: MPI 2 | Percentage of Cardiac Segments Obscured by Subdiaphragmatic Activity | Reader 1: Segment 4 | 37.4 percentage of segments |
Secondary
Percentage of Participants With Treatment-emergent Clinically Significant Cardiac Events
A clinically significant cardiac event is defined as: * Any of the following events found on the Holter electrocardiogram (ECG)/12-Lead ECG within 1 hour after regadenoson administration: * ventricular arrhythmias (sustained ventricular tachycardia, ventricular fibrillation, torsade de pointes, ventricular flutter), * ST-T depression (\> 2 mm), * ST-T elevation (≥1 mm), * Atrioventricular (AV) block (2:1 AV block, AV Mobitz I, AV Mobitz II, complete heart block) * sinus arrest \> 3 seconds in duration Or * a treatment-emergent adverse event (TEAE) per the Medical Dictionary for Regulatory Activities (MedDRA) Standardised MedDRA Queries (SMQ) (Narrow Scope) for myocardial infarction Or * a TEAE preferred term of angina unstable within 24 hours of regadenoson administration.
Time frame: Within 1 hour for ECG events and up to 24 hours for adverse events after administration of regadenoson
Population: Safety analysis set (all randomized participants who received at least 1 dose of regadenoson study drug)
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Regadenoson After Peak Exercise | Percentage of Participants With Treatment-emergent Clinically Significant Cardiac Events | Torsade de Pointes | 0.0 percentage of participants |
| Regadenoson After Peak Exercise | Percentage of Participants With Treatment-emergent Clinically Significant Cardiac Events | Any Event | 3.0 percentage of participants |
| Regadenoson After Peak Exercise | Percentage of Participants With Treatment-emergent Clinically Significant Cardiac Events | Ventricular Fibrillation or Ventricular Flutter | 0.0 percentage of participants |
| Regadenoson After Peak Exercise | Percentage of Participants With Treatment-emergent Clinically Significant Cardiac Events | Pause > 3.0 seconds | 0.0 percentage of participants |
| Regadenoson After Peak Exercise | Percentage of Participants With Treatment-emergent Clinically Significant Cardiac Events | Mobitz I Second Degree AV Block | 0.0 percentage of participants |
| Regadenoson After Peak Exercise | Percentage of Participants With Treatment-emergent Clinically Significant Cardiac Events | Adverse Event of Angina Unstable | 0.0 percentage of participants |
| Regadenoson After Peak Exercise | Percentage of Participants With Treatment-emergent Clinically Significant Cardiac Events | ST-T Depression (≥ 2 mm) | 2.3 percentage of participants |
| Regadenoson After Peak Exercise | Percentage of Participants With Treatment-emergent Clinically Significant Cardiac Events | Any TEAE per SMQ for Myocardial Infarction | 0.3 percentage of participants |
| Regadenoson After Peak Exercise | Percentage of Participants With Treatment-emergent Clinically Significant Cardiac Events | Any Holter/12-Lead ECG Abnormality | 2.8 percentage of participants |
| Regadenoson After Peak Exercise | Percentage of Participants With Treatment-emergent Clinically Significant Cardiac Events | Mobitz II Second Degree AV Block | 0.0 percentage of participants |
| Regadenoson After Peak Exercise | Percentage of Participants With Treatment-emergent Clinically Significant Cardiac Events | Acute Coronary Syndrome | 0.2 percentage of participants |
| Regadenoson After Peak Exercise | Percentage of Participants With Treatment-emergent Clinically Significant Cardiac Events | Sustained Ventricular Tachycardia | 0.0 percentage of participants |
| Regadenoson After Peak Exercise | Percentage of Participants With Treatment-emergent Clinically Significant Cardiac Events | ST-T Elevation (≥ 1 mm) | 0.5 percentage of participants |
| Regadenoson After Peak Exercise | Percentage of Participants With Treatment-emergent Clinically Significant Cardiac Events | Complete Heart Block | 0.0 percentage of participants |
| Regadenoson After Peak Exercise | Percentage of Participants With Treatment-emergent Clinically Significant Cardiac Events | Myocardial Infarction | 0.2 percentage of participants |
| Regadenoson After Peak Exercise | Percentage of Participants With Treatment-emergent Clinically Significant Cardiac Events | 2:1 AV Block | 0.0 percentage of participants |
| Regadenoson Alone | Percentage of Participants With Treatment-emergent Clinically Significant Cardiac Events | Myocardial Infarction | 0.0 percentage of participants |
| Regadenoson Alone | Percentage of Participants With Treatment-emergent Clinically Significant Cardiac Events | Any Holter/12-Lead ECG Abnormality | 0.9 percentage of participants |
| Regadenoson Alone | Percentage of Participants With Treatment-emergent Clinically Significant Cardiac Events | Ventricular Fibrillation or Ventricular Flutter | 0.0 percentage of participants |
| Regadenoson Alone | Percentage of Participants With Treatment-emergent Clinically Significant Cardiac Events | Sustained Ventricular Tachycardia | 0.0 percentage of participants |
| Regadenoson Alone | Percentage of Participants With Treatment-emergent Clinically Significant Cardiac Events | Mobitz I Second Degree AV Block | 0.0 percentage of participants |
| Regadenoson Alone | Percentage of Participants With Treatment-emergent Clinically Significant Cardiac Events | Adverse Event of Angina Unstable | 0.0 percentage of participants |
| Regadenoson Alone | Percentage of Participants With Treatment-emergent Clinically Significant Cardiac Events | Mobitz II Second Degree AV Block | 0.0 percentage of participants |
| Regadenoson Alone | Percentage of Participants With Treatment-emergent Clinically Significant Cardiac Events | Complete Heart Block | 0.0 percentage of participants |
| Regadenoson Alone | Percentage of Participants With Treatment-emergent Clinically Significant Cardiac Events | ST-T Elevation (≥ 1 mm) | 0.4 percentage of participants |
| Regadenoson Alone | Percentage of Participants With Treatment-emergent Clinically Significant Cardiac Events | ST-T Depression (≥ 2 mm) | 0.6 percentage of participants |
| Regadenoson Alone | Percentage of Participants With Treatment-emergent Clinically Significant Cardiac Events | Pause > 3.0 seconds | 0.0 percentage of participants |
| Regadenoson Alone | Percentage of Participants With Treatment-emergent Clinically Significant Cardiac Events | Any TEAE per SMQ for Myocardial Infarction | 0.0 percentage of participants |
| Regadenoson Alone | Percentage of Participants With Treatment-emergent Clinically Significant Cardiac Events | 2:1 AV Block | 0.0 percentage of participants |
| Regadenoson Alone | Percentage of Participants With Treatment-emergent Clinically Significant Cardiac Events | Acute Coronary Syndrome | 0.0 percentage of participants |
| Regadenoson Alone | Percentage of Participants With Treatment-emergent Clinically Significant Cardiac Events | Any Event | 0.9 percentage of participants |
| Regadenoson Alone | Percentage of Participants With Treatment-emergent Clinically Significant Cardiac Events | Torsade de Pointes | 0.0 percentage of participants |
| Regadenoson Alone: MPI 1 | Percentage of Participants With Treatment-emergent Clinically Significant Cardiac Events | Sustained Ventricular Tachycardia | 0.0 percentage of participants |
| Regadenoson Alone: MPI 1 | Percentage of Participants With Treatment-emergent Clinically Significant Cardiac Events | Torsade de Pointes | 0.0 percentage of participants |
| Regadenoson Alone: MPI 1 | Percentage of Participants With Treatment-emergent Clinically Significant Cardiac Events | 2:1 AV Block | 0.0 percentage of participants |
| Regadenoson Alone: MPI 1 | Percentage of Participants With Treatment-emergent Clinically Significant Cardiac Events | Mobitz I Second Degree AV Block | 0.0 percentage of participants |
| Regadenoson Alone: MPI 1 | Percentage of Participants With Treatment-emergent Clinically Significant Cardiac Events | Complete Heart Block | 0.0 percentage of participants |
| Regadenoson Alone: MPI 1 | Percentage of Participants With Treatment-emergent Clinically Significant Cardiac Events | Pause > 3.0 seconds | 0.0 percentage of participants |
| Regadenoson Alone: MPI 1 | Percentage of Participants With Treatment-emergent Clinically Significant Cardiac Events | Any TEAE per SMQ for Myocardial Infarction | 0.0 percentage of participants |
| Regadenoson Alone: MPI 1 | Percentage of Participants With Treatment-emergent Clinically Significant Cardiac Events | Acute Coronary Syndrome | 0.0 percentage of participants |
| Regadenoson Alone: MPI 1 | Percentage of Participants With Treatment-emergent Clinically Significant Cardiac Events | Any Event | 0.5 percentage of participants |
| Regadenoson Alone: MPI 1 | Percentage of Participants With Treatment-emergent Clinically Significant Cardiac Events | Any Holter/12-Lead ECG Abnormality | 0.5 percentage of participants |
| Regadenoson Alone: MPI 1 | Percentage of Participants With Treatment-emergent Clinically Significant Cardiac Events | Ventricular Fibrillation or Ventricular Flutter | 0.0 percentage of participants |
| Regadenoson Alone: MPI 1 | Percentage of Participants With Treatment-emergent Clinically Significant Cardiac Events | ST-T Depression (≥ 2 mm) | 0.4 percentage of participants |
| Regadenoson Alone: MPI 1 | Percentage of Participants With Treatment-emergent Clinically Significant Cardiac Events | ST-T Elevation (≥ 1 mm) | 0.2 percentage of participants |
| Regadenoson Alone: MPI 1 | Percentage of Participants With Treatment-emergent Clinically Significant Cardiac Events | Mobitz II Second Degree AV Block | 0.0 percentage of participants |
| Regadenoson Alone: MPI 1 | Percentage of Participants With Treatment-emergent Clinically Significant Cardiac Events | Myocardial Infarction | 0.0 percentage of participants |
| Regadenoson Alone: MPI 1 | Percentage of Participants With Treatment-emergent Clinically Significant Cardiac Events | Adverse Event of Angina Unstable | 0.0 percentage of participants |
| Regadenoson Alone: MPI 2 | Percentage of Participants With Treatment-emergent Clinically Significant Cardiac Events | Torsade de Pointes | 0.0 percentage of participants |
| Regadenoson Alone: MPI 2 | Percentage of Participants With Treatment-emergent Clinically Significant Cardiac Events | Pause > 3.0 seconds | 0.0 percentage of participants |
| Regadenoson Alone: MPI 2 | Percentage of Participants With Treatment-emergent Clinically Significant Cardiac Events | Complete Heart Block | 0.0 percentage of participants |
| Regadenoson Alone: MPI 2 | Percentage of Participants With Treatment-emergent Clinically Significant Cardiac Events | Myocardial Infarction | 0.0 percentage of participants |
| Regadenoson Alone: MPI 2 | Percentage of Participants With Treatment-emergent Clinically Significant Cardiac Events | Mobitz II Second Degree AV Block | 0.0 percentage of participants |
| Regadenoson Alone: MPI 2 | Percentage of Participants With Treatment-emergent Clinically Significant Cardiac Events | ST-T Elevation (≥ 1 mm) | 0.0 percentage of participants |
| Regadenoson Alone: MPI 2 | Percentage of Participants With Treatment-emergent Clinically Significant Cardiac Events | 2:1 AV Block | 0.0 percentage of participants |
| Regadenoson Alone: MPI 2 | Percentage of Participants With Treatment-emergent Clinically Significant Cardiac Events | Mobitz I Second Degree AV Block | 0.0 percentage of participants |
| Regadenoson Alone: MPI 2 | Percentage of Participants With Treatment-emergent Clinically Significant Cardiac Events | ST-T Depression (≥ 2 mm) | 0.4 percentage of participants |
| Regadenoson Alone: MPI 2 | Percentage of Participants With Treatment-emergent Clinically Significant Cardiac Events | Any TEAE per SMQ for Myocardial Infarction | 0.0 percentage of participants |
| Regadenoson Alone: MPI 2 | Percentage of Participants With Treatment-emergent Clinically Significant Cardiac Events | Sustained Ventricular Tachycardia | 0.0 percentage of participants |
| Regadenoson Alone: MPI 2 | Percentage of Participants With Treatment-emergent Clinically Significant Cardiac Events | Any Holter/12-Lead ECG Abnormality | 0.4 percentage of participants |
| Regadenoson Alone: MPI 2 | Percentage of Participants With Treatment-emergent Clinically Significant Cardiac Events | Adverse Event of Angina Unstable | 0.0 percentage of participants |
| Regadenoson Alone: MPI 2 | Percentage of Participants With Treatment-emergent Clinically Significant Cardiac Events | Ventricular Fibrillation or Ventricular Flutter | 0.0 percentage of participants |
| Regadenoson Alone: MPI 2 | Percentage of Participants With Treatment-emergent Clinically Significant Cardiac Events | Any Event | 0.4 percentage of participants |
| Regadenoson Alone: MPI 2 | Percentage of Participants With Treatment-emergent Clinically Significant Cardiac Events | Acute Coronary Syndrome | 0.0 percentage of participants |
Secondary
Percentage of Scans With Subdiaphragmatic Interference
Each reader assessed the sub-diaphragmatic radiotracer interference with cardiac image quality using a 4-point scale of 0 = none, 1 = slight, 2 = moderate or 3 = severe for each stress SPECT MPI. The median rating across the 3 readers was used to summarize the percentage of scans with interference.
Time frame: Day 1 (stress MPI 1) and Day 2 -15 (stress MPI 2)
Population: Full Analysis Set
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Regadenoson After Peak Exercise | Percentage of Scans With Subdiaphragmatic Interference | None | 0.4 percentage of stress MPI scans |
| Regadenoson After Peak Exercise | Percentage of Scans With Subdiaphragmatic Interference | Slight | 71.8 percentage of stress MPI scans |
| Regadenoson After Peak Exercise | Percentage of Scans With Subdiaphragmatic Interference | Moderate | 27.5 percentage of stress MPI scans |
| Regadenoson After Peak Exercise | Percentage of Scans With Subdiaphragmatic Interference | Severe | 0.4 percentage of stress MPI scans |
| Regadenoson Alone | Percentage of Scans With Subdiaphragmatic Interference | Slight | 63.7 percentage of stress MPI scans |
| Regadenoson Alone | Percentage of Scans With Subdiaphragmatic Interference | Moderate | 36.3 percentage of stress MPI scans |
| Regadenoson Alone | Percentage of Scans With Subdiaphragmatic Interference | Severe | 0.0 percentage of stress MPI scans |
| Regadenoson Alone | Percentage of Scans With Subdiaphragmatic Interference | None | 0.0 percentage of stress MPI scans |
| Regadenoson Alone: MPI 1 | Percentage of Scans With Subdiaphragmatic Interference | Moderate | 31.5 percentage of stress MPI scans |
| Regadenoson Alone: MPI 1 | Percentage of Scans With Subdiaphragmatic Interference | Slight | 68.1 percentage of stress MPI scans |
| Regadenoson Alone: MPI 1 | Percentage of Scans With Subdiaphragmatic Interference | Severe | 0.4 percentage of stress MPI scans |
| Regadenoson Alone: MPI 1 | Percentage of Scans With Subdiaphragmatic Interference | None | 0.0 percentage of stress MPI scans |
| Regadenoson Alone: MPI 2 | Percentage of Scans With Subdiaphragmatic Interference | Severe | 0.0 percentage of stress MPI scans |
| Regadenoson Alone: MPI 2 | Percentage of Scans With Subdiaphragmatic Interference | Slight | 67.4 percentage of stress MPI scans |
| Regadenoson Alone: MPI 2 | Percentage of Scans With Subdiaphragmatic Interference | None | 0.0 percentage of stress MPI scans |
| Regadenoson Alone: MPI 2 | Percentage of Scans With Subdiaphragmatic Interference | Moderate | 32.6 percentage of stress MPI scans |
Secondary
Proportion of Participants With Agreement in the Assessment of Absence or Presence of Ischemia Between First and Second Stress Scans
The number of segments with reversible defects was assessed by each of the 3 blinded independent expert readers. Based on the median count of the number of reversible defects across the 3 readers, categorized as absence (0 to 1 reversible segments) or presence (≥ 2 reversible defects) of ischemia, the proportion of participants with agreement in the presence and absence of ischemia between the first and second stress scans was calculated.
Time frame: Day 1 (stress MPI 1) and Day 2 -15 (stress MPI 2)
Population: Full Analysis Set
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Regadenoson After Peak Exercise | Proportion of Participants With Agreement in the Assessment of Absence or Presence of Ischemia Between First and Second Stress Scans | 0.75 proportion of participants |
| Regadenoson Alone | Proportion of Participants With Agreement in the Assessment of Absence or Presence of Ischemia Between First and Second Stress Scans | 0.77 proportion of participants |
95% CI: [-0.14, 0.11]
Secondary
Proportion of Participants With Agreement in the Assessment of Reversible Defects in 3 Categories of Ischemia Between First and Second Stress Scans
The number of segments with reversible defects was assessed by each of the 3 blinded independent expert readers. Based on the median count of the number of reversible defects across the 3 readers, categorized as 0 to 1, 2 to 4, or ≥ 5 reversible segments, the proportion of participants with agreement in the three ischemia categories between the first and second stress scans was to be calculated. In the reported data, these proportions only include the 0-1 and 2-4 categories; the ≥ 5 category was not included because there were no participants in this category for the Regadenoson Alone group for the initial stress MPI.
Time frame: Day 1 (stress MPI 1) and Day 2 - 15 (stress MPI 2)
Population: Full Analysis Set
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Regadenoson After Peak Exercise | Proportion of Participants With Agreement in the Assessment of Reversible Defects in 3 Categories of Ischemia Between First and Second Stress Scans | 0.73 proportion of participants |
| Regadenoson Alone | Proportion of Participants With Agreement in the Assessment of Reversible Defects in 3 Categories of Ischemia Between First and Second Stress Scans | 0.75 proportion of participants |
95% CI: [-0.07, 0.04]
Secondary
Proportion of Participants With Agreement in the Summed Difference Score (SDS) Between First and Second Stress Scans
The 17-segment model for standardized myocardial segmentation was used to analyze MPI scans. At rest and stress, each segment was scored on a 0 to 4 scale according to the amount of contrast or radiotracer the myocardium in the segment absorbed: * 0: normal perfusion * 1: slightly reduced contrast/ uptake * 2: moderately reduced contrast/uptake * 3: severely reduced contrast/uptake * 4: absent contrast/uptake. SSS was calculated as the sum of the stress scores across the 17 segments and the Summed Rest Score (SRS) was calculated as the sum of the rest scores across the 17 segments. The Summed Difference Score (SDS) is the difference in the SSS and SRS (SSS - SRS). The mean value (rounded to the nearest integer) across the 3 readers was computed and the SDS was categorized into 3 categorical variables based on the score: 0 to 6, 7 to 13 and ≥ 14. The proportion of participants with agreement in respect to these categories between the two stress scans was calculated.
Time frame: Day 1 (rest MPI and stress MPI 1) and Day 2 - 15 (stress MPI 2)
Population: Full Analysis Set
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Regadenoson After Peak Exercise | Proportion of Participants With Agreement in the Summed Difference Score (SDS) Between First and Second Stress Scans | MPI 1 SDS 7-13 | 0 participants |
| Regadenoson After Peak Exercise | Proportion of Participants With Agreement in the Summed Difference Score (SDS) Between First and Second Stress Scans | MPI 1 SDS 0-6 | 531 participants |
| Regadenoson After Peak Exercise | Proportion of Participants With Agreement in the Summed Difference Score (SDS) Between First and Second Stress Scans | MPI 1 SDS ≥ 14 | 0 participants |
| Regadenoson Alone | Proportion of Participants With Agreement in the Summed Difference Score (SDS) Between First and Second Stress Scans | MPI 1 SDS 7-13 | 3 participants |
| Regadenoson Alone | Proportion of Participants With Agreement in the Summed Difference Score (SDS) Between First and Second Stress Scans | MPI 1 SDS 0-6 | 4 participants |
| Regadenoson Alone | Proportion of Participants With Agreement in the Summed Difference Score (SDS) Between First and Second Stress Scans | MPI 1 SDS ≥ 14 | 0 participants |
| Regadenoson Alone: MPI 1 | Proportion of Participants With Agreement in the Summed Difference Score (SDS) Between First and Second Stress Scans | MPI 1 SDS 7-13 | 0 participants |
| Regadenoson Alone: MPI 1 | Proportion of Participants With Agreement in the Summed Difference Score (SDS) Between First and Second Stress Scans | MPI 1 SDS 0-6 | 0 participants |
| Regadenoson Alone: MPI 1 | Proportion of Participants With Agreement in the Summed Difference Score (SDS) Between First and Second Stress Scans | MPI 1 SDS ≥ 14 | 0 participants |
| Regadenoson Alone: MPI 2 | Proportion of Participants With Agreement in the Summed Difference Score (SDS) Between First and Second Stress Scans | MPI 1 SDS 7-13 | 2 participants |
| Regadenoson Alone: MPI 2 | Proportion of Participants With Agreement in the Summed Difference Score (SDS) Between First and Second Stress Scans | MPI 1 SDS 0-6 | 527 participants |
| Regadenoson Alone: MPI 2 | Proportion of Participants With Agreement in the Summed Difference Score (SDS) Between First and Second Stress Scans | MPI 1 SDS ≥ 14 | 0 participants |
| REG Alone: MPI 2 SDS 7-13 | Proportion of Participants With Agreement in the Summed Difference Score (SDS) Between First and Second Stress Scans | MPI 1 SDS 7-13 | 3 participants |
| REG Alone: MPI 2 SDS 7-13 | Proportion of Participants With Agreement in the Summed Difference Score (SDS) Between First and Second Stress Scans | MPI 1 SDS 0-6 | 3 participants |
| REG Alone: MPI 2 SDS 7-13 | Proportion of Participants With Agreement in the Summed Difference Score (SDS) Between First and Second Stress Scans | MPI 1 SDS ≥ 14 | 0 participants |
| REG Alone: MPI 2 SDS ≥ 14 | Proportion of Participants With Agreement in the Summed Difference Score (SDS) Between First and Second Stress Scans | MPI 1 SDS 0-6 | 0 participants |
| REG Alone: MPI 2 SDS ≥ 14 | Proportion of Participants With Agreement in the Summed Difference Score (SDS) Between First and Second Stress Scans | MPI 1 SDS ≥ 14 | 0 participants |
| REG Alone: MPI 2 SDS ≥ 14 | Proportion of Participants With Agreement in the Summed Difference Score (SDS) Between First and Second Stress Scans | MPI 1 SDS 7-13 | 0 participants |
Secondary
Proportion of Participants With Agreement in the Summed Stress Score (SSS) Between First and Second Stress Scans
The 17-segment model for standardized myocardial segmentation was used to analyze MPI scans. Each segment was scored on a 0 to 4 scale according to the amount of contrast or radiotracer the myocardium in the segment absorbed: * 0: normal perfusion * 1: slightly reduced contrast/radiotracer uptake * 2: moderately reduced contrast/radiotracer uptake * 3: severely reduced contrast/radiotracer uptake * 4: absent contrast/radiotracer uptake. The Summed Stress Score (SSS) was calculated as the sum of the stress scores across the 17 segments. The mean value (rounded to the nearest integer) across the 3 readers was computed and the SSS was categorized into 4 group categorical variables based on the score: 0 to 3, 4 to 7, 8 to 11, and ≥ 12. The proportion of participants with agreement in respect to these categories between the two stress scans was calculated.
Time frame: Day 1 (stress MPI 1) and Day 2 - 15 (stress MPI 2)
Population: Full Analysis Set
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Regadenoson After Peak Exercise | Proportion of Participants With Agreement in the Summed Stress Score (SSS) Between First and Second Stress Scans | 0.86 proportion of participants |
| Regadenoson Alone | Proportion of Participants With Agreement in the Summed Stress Score (SSS) Between First and Second Stress Scans | 0.84 proportion of participants |
95% CI: [-0.03, 0.06]
Secondary
Target to Background Radiotracer Uptake Ratios From the First and Second Stress Scans
Image quality was assessed through radiotracer uptake in the heart (target organ) compared to liver, gut and combined liver plus gut (background interference).
Time frame: Day 1 (stress MPI 1) and Day 2 - 15 (stress MPI 2)
Population: Full analysis set participants who have planar images available for each scan
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Regadenoson After Peak Exercise | Target to Background Radiotracer Uptake Ratios From the First and Second Stress Scans | Heart-to-(Liver/Gut) | 1.02 ratio | Standard Deviation 0.296 |
| Regadenoson After Peak Exercise | Target to Background Radiotracer Uptake Ratios From the First and Second Stress Scans | Heart-to-Liver | 1.05 ratio | Standard Deviation 0.399 |
| Regadenoson After Peak Exercise | Target to Background Radiotracer Uptake Ratios From the First and Second Stress Scans | Heart-to-Gut | 1.12 ratio | Standard Deviation 0.436 |
| Regadenoson Alone | Target to Background Radiotracer Uptake Ratios From the First and Second Stress Scans | Heart-to-Gut | 0.99 ratio | Standard Deviation 0.399 |
| Regadenoson Alone | Target to Background Radiotracer Uptake Ratios From the First and Second Stress Scans | Heart-to-Liver | 0.94 ratio | Standard Deviation 0.373 |
| Regadenoson Alone | Target to Background Radiotracer Uptake Ratios From the First and Second Stress Scans | Heart-to-(Liver/Gut) | 0.90 ratio | Standard Deviation 0.26 |
| Regadenoson Alone: MPI 1 | Target to Background Radiotracer Uptake Ratios From the First and Second Stress Scans | Heart-to-(Liver/Gut) | 0.94 ratio | Standard Deviation 0.274 |
| Regadenoson Alone: MPI 1 | Target to Background Radiotracer Uptake Ratios From the First and Second Stress Scans | Heart-to-Liver | 0.96 ratio | Standard Deviation 0.365 |
| Regadenoson Alone: MPI 1 | Target to Background Radiotracer Uptake Ratios From the First and Second Stress Scans | Heart-to-Gut | 1.05 ratio | Standard Deviation 0.428 |
| Regadenoson Alone: MPI 2 | Target to Background Radiotracer Uptake Ratios From the First and Second Stress Scans | Heart-to-Gut | 0.99 ratio | Standard Deviation 0.387 |
| Regadenoson Alone: MPI 2 | Target to Background Radiotracer Uptake Ratios From the First and Second Stress Scans | Heart-to-Liver | 0.95 ratio | Standard Deviation 0.362 |
| Regadenoson Alone: MPI 2 | Target to Background Radiotracer Uptake Ratios From the First and Second Stress Scans | Heart-to-(Liver/Gut) | 0.91 ratio | Standard Deviation 0.259 |