Coronary Artery Disease (CAD)
Conditions
Keywords
pharmacologic stress, Coronary Artery Disease (CAD), regadenoson, ischemia
Brief summary
The purpose of this study is to compare Multidetector Computed Tomography (MDCT) and Single Photon Emission Computed Tomography (SPECT) stress myocardial perfusion imaging (MPI) with regadenoson in order to detect the presence or absence of reversible defects.
Detailed description
All participants will be randomized to one of two imaging sequences: rest/stress SPECT on Day 1 followed by stress/rest MDCT on Day 2 or stress/rest MDCT on Day 1 followed by rest/stress SPECT on Day 2. All stress scans will involve the injection of regadenoson as the pharmacologic stress agent.
Interventions
DRUGregadenoson
Administered by intravenous bolus.
RADIATIONtechnetium Tc99m sestamibi /technetium Tc99m tetrafosmin
Administered by intravenous infusion
RADIATIONContrast
Administered by intravenous infusion.
PROCEDURESingle Photon Emission Computed Tomography
Procedure/Surgery
PROCEDUREMultidetector Computed Tomography
Procedure/Surgery
Sponsors
Astellas Pharma Inc
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
45 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Male subjects must be ≥ 45 years of age * Female subjects must be ≥ 50 years of age * Subject has met at least one of the following three criteria: * has a suspected (clinical impression) or known diagnosis of coronary artery disease (CAD) with typical angina that has been referred from nuclear cardiology lab schedule or cardiac computed tomography (CT) schedule * has stable symptoms with possible elective catheterization procedure scheduled and where further imaging may be beneficial; * has known CAD from a previous invasive coronary angiography (ICA) performed more than 12 weeks prior to screening who now present with new cardiac symptoms * Subject has been referred for a clinically indicated myocardial perfusion imaging procedure or Cardiac CT procedure for suspected moderate or high risk CAD * Subject must abstain from eating and drinking 30 minutes prior and 30 minutes post study drug administration * Subject must abstain from smoking 3 hours prior and 8 hours post study drug administration * Subject must abstain from any intake of methylxanthine-containing foods and beverages within 12 hours prior to Day 1 visit through the Day 3 Follow-Up Visit, as these foods may alter regadenoson effects. Subject is able to safely abstain from theophylline use for 12 hours prior to study drug administration
Exclusion criteria
* Subject is concurrently participating in another drug study or has received an investigational drug within 30 days prior to Screening * Subject has a history of a clinically significant illness (other than CAD), medical condition, or laboratory abnormality, which would preclude participation in the study * Subject has renal dysfunction demonstrated by a glomerular filtration rate (GFR) \< 45 mL/min (calculated using Cockroft-Gault formula Note: Subjects with a GFR 45-60 mL/min will undergo a hydration procedure * Female subject who is pregnant, lactating or of childbearing potential that refuses to use a medically acceptable form of contraception until the Telephone Follow up Visit is complete * Female subject has a positive pregnancy test prior to randomization * Subject has a history of second or third degree heart block or sinus node dysfunction unless the subject has a functioning pacemaker * Subject has symptomatic hypotension (temporary and reversible conditions that no longer exist are allowed) * Subject is allergic or intolerant to aminophylline, nitroglycerin or metoprolol * Subject is allergic or intolerant to regadenoson or any of its excipients * Subject is unable or unwilling to comply with the procedure schedule * Subject has previously enrolled in this study or was enrolled in another regadenoson study sponsored by Astellas * Subject has atrial fibrillation or significant arrhythmias which may result in decreased image quality for the imaging studies (CT and SPECT) * Subject has high heart rate (\> 65 beats per minute) and contra-indications to administer beta-blockers (severe chronic obstructive pulmonary disease (COPD) or asthma, second and third degree atrioventricular block)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Reversible Defects | Day 1 and Day 2 | The number of reversible defects categorized into absence or presence of ischemia (0-1 versus ≥2), as assessed by the central imaging laboratory for both SPECT and MDCT. The 17-segment model for standardized myocardial segmentation was used for myocardial perfusion readings for SPECT and MDCT. 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/radiotracer uptake -2: moderately reduced contrast/radiotracer uptake -3: severely reduced contrast/radiotracer uptake -4: absent contrast/radiotracer uptake. The median score from the 3 blinded readers for each segment was used. 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. A participant was classified as ischemic in the presence of 2 or more segments with reversible defects, excluding segment 17. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Overall Image Quality of Scans by Modality and Reviewer | Day 1 and Day 2 | Overall image quality was assessed by three independent blinded readers for each modality (single photon emission computed tomography (SPECT) and multidetector computed tomography (MDCT)). Image quality was rated on a 4-point scale as either excellent, good, fair or poor at rest using SPECT and MDCT and under stress using regadenoson SPECT and regadenoson stress computed tomography perfusion (CTP). |
| Number of Participants With Reversible Defects in the Left Anterior Descending Coronary Artery (LAD) | Day 1 and Day 2 | The number of reversible defects in the LAD categorized into absence or presence of ischemia (0-1 versus ≥2), as assessed by the central imaging laboratory for both SPECT and MDCT. The 17-segment model for standardized myocardial segmentation was used for myocardial perfusion readings for SPECT and MDCT. 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/radiotracer uptake -2: moderately reduced contrast/radiotracer uptake -3: severely reduced contrast/radiotracer uptake -4: absent contrast/radiotracer uptake. The median score from 3 blinded readers for each segment was used. 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. A participant was classified as ischemic in the presence of ≥ 2 segments with reversible defects, excluding segment 17. |
| Number of Participants With Reversible Defects in the Right Coronary Artery (RCA) | Day 1 and Day 2 | The number of reversible defects in the RCA categorized into absence or presence of ischemia (0-1 versus ≥2), as assessed by the central imaging laboratory for both SPECT and MDCT. The 17-segment model for standardized myocardial segmentation was used for myocardial perfusion readings for SPECT and MDCT. 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/radiotracer uptake -2: moderately reduced contrast/radiotracer uptake -3: severely reduced contrast/radiotracer uptake -4: absent contrast/radiotracer uptake. The median score from 3 blinded readers for each segment was used. 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. A participant was classified as ischemic in the presence of ≥ 2 segments with reversible defects, excluding segment 17. |
| Number of Participants With Reversible Defects in the Left Circumflex Coronary Artery (LCX) | Day 1 and Day 2 | The number of reversible defects in the LCX categorized into absence or presence of ischemia (0-1 versus ≥2), as assessed by the central imaging laboratory for both SPECT and MDCT. The 17-segment model for standardized myocardial segmentation was used for myocardial perfusion readings for SPECT and MDCT. 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/radiotracer uptake -2: moderately reduced contrast/radiotracer uptake -3: severely reduced contrast/radiotracer uptake -4: absent contrast/radiotracer uptake. The median score from 3 blinded readers for each segment was used. 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. A participant was classified as ischemic in the presence of ≥ 2 segments with reversible defects, excluding segment 17. |
| Number of Participants With Fixed Defects | Day 1 and Day 2 | Using the 17-segment scoring system, a segment scored above 1 (i.e., 2 to 4) and equal at rest and stress was counted as having a fixed defect. 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/radiotracer uptake -2: moderately reduced contrast/radiotracer uptake -3: severely reduced contrast/radiotracer uptake -4: absent contrast/radiotracer uptake. |
| Percentage of Participants With Two or More Ischemic Segments on SPECT, But Less on CT | Day 1 and Day 2 | Using SPECT as the reference standard, the false negative percentage was calculated as the percentage of participants with two or more ischemic segments on SPECT, but less on CT. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Sequence 1: SPECT - MDCT Day 1: a rest Single Photon Emission Computed Tomography (SPECT) and a regadenoson stress SPECT procedure. Day 2: a regadenoson stress Computed Tomography Perfusion (CTP) and a rest Coronary Computed Tomography Angiography (CCTA)/CTP procedure. Regadenoson 0.4 mg was administered prior to each stress procedure as a single bolus injection. | 57 |
| Sequence 2: MDCT - SPECT Day 1: a regadenoson stress CTP and a rest CCTA/CTP procedure. Day 2: a rest SPECT and a regadenoson stress SPECT procedure. Regadenoson 0.4 mg was administered prior to each stress procedure as a single bolus injection. | 61 |
| Total | 118 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Adverse Event | 2 | 0 |
| Overall Study | Did not receive study drug | 6 | 0 |
| Overall Study | Withdrawal by Subject | 0 | 1 |
Baseline characteristics
| Characteristic | Sequence 1: SPECT - MDCT | Sequence 2: MDCT - SPECT | Total |
|---|---|---|---|
| Age, Continuous | 60.8 years STANDARD_DEVIATION 9.19 | 62.3 years STANDARD_DEVIATION 9.41 | 61.6 years STANDARD_DEVIATION 9.29 |
| Race/Ethnicity, Customized Asian | 3 participants | 2 participants | 5 participants |
| Race/Ethnicity, Customized Black or African American | 2 participants | 5 participants | 7 participants |
| Race/Ethnicity, Customized Hispanic or Latino | 20 participants | 20 participants | 40 participants |
| Race/Ethnicity, Customized Not Hispanic or Latino | 37 participants | 41 participants | 78 participants |
| Race/Ethnicity, Customized White | 52 participants | 54 participants | 106 participants |
| Sex: Female, Male Female | 18 Participants | 15 Participants | 33 Participants |
| Sex: Female, Male Male | 39 Participants | 46 Participants | 85 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 53 / 117 | 59 / 116 |
| serious Total, serious adverse events | 1 / 117 | 0 / 116 |
Outcome results
Primary
Number of Participants With Reversible Defects
The number of reversible defects categorized into absence or presence of ischemia (0-1 versus ≥2), as assessed by the central imaging laboratory for both SPECT and MDCT. The 17-segment model for standardized myocardial segmentation was used for myocardial perfusion readings for SPECT and MDCT. 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/radiotracer uptake -2: moderately reduced contrast/radiotracer uptake -3: severely reduced contrast/radiotracer uptake -4: absent contrast/radiotracer uptake. The median score from the 3 blinded readers for each segment was used. 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. A participant was classified as ischemic in the presence of 2 or more segments with reversible defects, excluding segment 17.
Time frame: Day 1 and Day 2
Population: The number of participants analyzed represents the full analysis set, defined as all randomized patients with interpretable SPECT and CTP scans as determined by at least two of the three blinded readers.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| CTP: 0 - 1 Reversible Defects | Number of Participants With Reversible Defects | SPECT: All Reversible defects | 85 participants |
| CTP: 0 - 1 Reversible Defects | Number of Participants With Reversible Defects | SPECT: 0-1 Reversible defects | 84 participants |
| CTP: 0 - 1 Reversible Defects | Number of Participants With Reversible Defects | SPECT: ≥ 2 Reversible defects | 1 participants |
| CTP: ≥ 2 Reversible Defects | Number of Participants With Reversible Defects | SPECT: All Reversible defects | 25 participants |
| CTP: ≥ 2 Reversible Defects | Number of Participants With Reversible Defects | SPECT: 0-1 Reversible defects | 16 participants |
| CTP: ≥ 2 Reversible Defects | Number of Participants With Reversible Defects | SPECT: ≥ 2 Reversible defects | 9 participants |
| CTP: All Reversible Defects | Number of Participants With Reversible Defects | SPECT: All Reversible defects | 110 participants |
| CTP: All Reversible Defects | Number of Participants With Reversible Defects | SPECT: 0-1 Reversible defects | 100 participants |
| CTP: All Reversible Defects | Number of Participants With Reversible Defects | SPECT: ≥ 2 Reversible defects | 10 participants |
Comparison: Analysis of agreement rate based on participants with 0 -1 and ≥ 2 reversible defects according to SPECT. Agreement is defined as the proportion of participants who had the same status from SPECT and MDCT, averaged across those with 2 or more reversible defects and those without, where SPECT is the reference standard.95% CI: [0.77, 0.97]
Secondary
Number of Participants With Fixed Defects
Using the 17-segment scoring system, a segment scored above 1 (i.e., 2 to 4) and equal at rest and stress was counted as having a fixed defect. 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/radiotracer uptake -2: moderately reduced contrast/radiotracer uptake -3: severely reduced contrast/radiotracer uptake -4: absent contrast/radiotracer uptake.
Time frame: Day 1 and Day 2
Population: The number of participants analyzed represents the full analysis set.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| CTP: 0 - 1 Reversible Defects | Number of Participants With Fixed Defects | SPECT: 0 Fixed Defects | 92 participants |
| CTP: 0 - 1 Reversible Defects | Number of Participants With Fixed Defects | SPECT: All Fixed Defects | 95 participants |
| CTP: 0 - 1 Reversible Defects | Number of Participants With Fixed Defects | SPECT: ≥ 1 Fixed Defects | 3 participants |
| CTP: ≥ 2 Reversible Defects | Number of Participants With Fixed Defects | SPECT: 0 Fixed Defects | 5 participants |
| CTP: ≥ 2 Reversible Defects | Number of Participants With Fixed Defects | SPECT: All Fixed Defects | 15 participants |
| CTP: ≥ 2 Reversible Defects | Number of Participants With Fixed Defects | SPECT: ≥ 1 Fixed Defects | 10 participants |
| CTP: All Reversible Defects | Number of Participants With Fixed Defects | SPECT: All Fixed Defects | 110 participants |
| CTP: All Reversible Defects | Number of Participants With Fixed Defects | SPECT: ≥ 1 Fixed Defects | 13 participants |
| CTP: All Reversible Defects | Number of Participants With Fixed Defects | SPECT: 0 Fixed Defects | 97 participants |
Comparison: Analysis of specificity based on participants with no fixed defects according to SPECT. Specificity is defined as a proportion of true negatives that are correctly identified, using SPECT as the reference standard.95% CI: [0.9, 0.99]
Comparison: Analysis of sensitivity based on participants with ≥ 1 fixed defect according to SPECT. Sensitivity is the proportion of true positives that are correctly identified using SPECT as the reference standard.95% CI: [0.54, 1]
Secondary
Number of Participants With Reversible Defects in the Left Anterior Descending Coronary Artery (LAD)
The number of reversible defects in the LAD categorized into absence or presence of ischemia (0-1 versus ≥2), as assessed by the central imaging laboratory for both SPECT and MDCT. The 17-segment model for standardized myocardial segmentation was used for myocardial perfusion readings for SPECT and MDCT. 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/radiotracer uptake -2: moderately reduced contrast/radiotracer uptake -3: severely reduced contrast/radiotracer uptake -4: absent contrast/radiotracer uptake. The median score from 3 blinded readers for each segment was used. 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. A participant was classified as ischemic in the presence of ≥ 2 segments with reversible defects, excluding segment 17.
Time frame: Day 1 and Day 2
Population: The number of participants analyzed represents the full analysis set where scans were available.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| CTP: 0 - 1 Reversible Defects | Number of Participants With Reversible Defects in the Left Anterior Descending Coronary Artery (LAD) | SPECT: ≥ 2 Reversible defects | 0 participants |
| CTP: 0 - 1 Reversible Defects | Number of Participants With Reversible Defects in the Left Anterior Descending Coronary Artery (LAD) | SPECT: 0 - 1 Reversible defects | 90 participants |
| CTP: 0 - 1 Reversible Defects | Number of Participants With Reversible Defects in the Left Anterior Descending Coronary Artery (LAD) | SPECT: All Reversible defects | 90 participants |
| CTP: ≥ 2 Reversible Defects | Number of Participants With Reversible Defects in the Left Anterior Descending Coronary Artery (LAD) | SPECT: ≥ 2 Reversible defects | 4 participants |
| CTP: ≥ 2 Reversible Defects | Number of Participants With Reversible Defects in the Left Anterior Descending Coronary Artery (LAD) | SPECT: 0 - 1 Reversible defects | 11 participants |
| CTP: ≥ 2 Reversible Defects | Number of Participants With Reversible Defects in the Left Anterior Descending Coronary Artery (LAD) | SPECT: All Reversible defects | 15 participants |
| CTP: All Reversible Defects | Number of Participants With Reversible Defects in the Left Anterior Descending Coronary Artery (LAD) | SPECT: 0 - 1 Reversible defects | 101 participants |
| CTP: All Reversible Defects | Number of Participants With Reversible Defects in the Left Anterior Descending Coronary Artery (LAD) | SPECT: All Reversible defects | 105 participants |
| CTP: All Reversible Defects | Number of Participants With Reversible Defects in the Left Anterior Descending Coronary Artery (LAD) | SPECT: ≥ 2 Reversible defects | 4 participants |
Secondary
Number of Participants With Reversible Defects in the Left Circumflex Coronary Artery (LCX)
The number of reversible defects in the LCX categorized into absence or presence of ischemia (0-1 versus ≥2), as assessed by the central imaging laboratory for both SPECT and MDCT. The 17-segment model for standardized myocardial segmentation was used for myocardial perfusion readings for SPECT and MDCT. 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/radiotracer uptake -2: moderately reduced contrast/radiotracer uptake -3: severely reduced contrast/radiotracer uptake -4: absent contrast/radiotracer uptake. The median score from 3 blinded readers for each segment was used. 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. A participant was classified as ischemic in the presence of ≥ 2 segments with reversible defects, excluding segment 17.
Time frame: Day 1 and Day 2
Population: The number of participants analyzed represents the full analysis set where scans were available.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| CTP: 0 - 1 Reversible Defects | Number of Participants With Reversible Defects in the Left Circumflex Coronary Artery (LCX) | SPECT: ≥ 2 Reversible defects | 2 participants |
| CTP: 0 - 1 Reversible Defects | Number of Participants With Reversible Defects in the Left Circumflex Coronary Artery (LCX) | SPECT: 0 - 1 Reversible defects | 90 participants |
| CTP: 0 - 1 Reversible Defects | Number of Participants With Reversible Defects in the Left Circumflex Coronary Artery (LCX) | SPECT: All Reversible defects | 92 participants |
| CTP: ≥ 2 Reversible Defects | Number of Participants With Reversible Defects in the Left Circumflex Coronary Artery (LCX) | SPECT: ≥ 2 Reversible defects | 4 participants |
| CTP: ≥ 2 Reversible Defects | Number of Participants With Reversible Defects in the Left Circumflex Coronary Artery (LCX) | SPECT: 0 - 1 Reversible defects | 9 participants |
| CTP: ≥ 2 Reversible Defects | Number of Participants With Reversible Defects in the Left Circumflex Coronary Artery (LCX) | SPECT: All Reversible defects | 13 participants |
| CTP: All Reversible Defects | Number of Participants With Reversible Defects in the Left Circumflex Coronary Artery (LCX) | SPECT: 0 - 1 Reversible defects | 99 participants |
| CTP: All Reversible Defects | Number of Participants With Reversible Defects in the Left Circumflex Coronary Artery (LCX) | SPECT: All Reversible defects | 105 participants |
| CTP: All Reversible Defects | Number of Participants With Reversible Defects in the Left Circumflex Coronary Artery (LCX) | SPECT: ≥ 2 Reversible defects | 6 participants |
Secondary
Number of Participants With Reversible Defects in the Right Coronary Artery (RCA)
The number of reversible defects in the RCA categorized into absence or presence of ischemia (0-1 versus ≥2), as assessed by the central imaging laboratory for both SPECT and MDCT. The 17-segment model for standardized myocardial segmentation was used for myocardial perfusion readings for SPECT and MDCT. 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/radiotracer uptake -2: moderately reduced contrast/radiotracer uptake -3: severely reduced contrast/radiotracer uptake -4: absent contrast/radiotracer uptake. The median score from 3 blinded readers for each segment was used. 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. A participant was classified as ischemic in the presence of ≥ 2 segments with reversible defects, excluding segment 17.
Time frame: Day 1 and Day 2
Population: The number of participants analyzed represents the full analysis set where scans were available.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| CTP: 0 - 1 Reversible Defects | Number of Participants With Reversible Defects in the Right Coronary Artery (RCA) | SPECT: 0 - 1 Reversible defects | 92 participants |
| CTP: 0 - 1 Reversible Defects | Number of Participants With Reversible Defects in the Right Coronary Artery (RCA) | SPECT: ≥ 2 Reversible defects | 1 participants |
| CTP: 0 - 1 Reversible Defects | Number of Participants With Reversible Defects in the Right Coronary Artery (RCA) | SPECT: All Reversible defects | 93 participants |
| CTP: ≥ 2 Reversible Defects | Number of Participants With Reversible Defects in the Right Coronary Artery (RCA) | SPECT: All Reversible defects | 5 participants |
| CTP: ≥ 2 Reversible Defects | Number of Participants With Reversible Defects in the Right Coronary Artery (RCA) | SPECT: 0 - 1 Reversible defects | 5 participants |
| CTP: ≥ 2 Reversible Defects | Number of Participants With Reversible Defects in the Right Coronary Artery (RCA) | SPECT: ≥ 2 Reversible defects | 0 participants |
| CTP: All Reversible Defects | Number of Participants With Reversible Defects in the Right Coronary Artery (RCA) | SPECT: ≥ 2 Reversible defects | 1 participants |
| CTP: All Reversible Defects | Number of Participants With Reversible Defects in the Right Coronary Artery (RCA) | SPECT: 0 - 1 Reversible defects | 97 participants |
| CTP: All Reversible Defects | Number of Participants With Reversible Defects in the Right Coronary Artery (RCA) | SPECT: All Reversible defects | 98 participants |
Secondary
Overall Image Quality of Scans by Modality and Reviewer
Overall image quality was assessed by three independent blinded readers for each modality (single photon emission computed tomography (SPECT) and multidetector computed tomography (MDCT)). Image quality was rated on a 4-point scale as either excellent, good, fair or poor at rest using SPECT and MDCT and under stress using regadenoson SPECT and regadenoson stress computed tomography perfusion (CTP).
Time frame: Day 1 and Day 2
Population: The number of participants analyzed represents the full analysis set.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| CTP: 0 - 1 Reversible Defects | Overall Image Quality of Scans by Modality and Reviewer | Rest: Poor | 1 participants |
| CTP: 0 - 1 Reversible Defects | Overall Image Quality of Scans by Modality and Reviewer | Rest: Fair | 4 participants |
| CTP: 0 - 1 Reversible Defects | Overall Image Quality of Scans by Modality and Reviewer | Rest: Good | 16 participants |
| CTP: 0 - 1 Reversible Defects | Overall Image Quality of Scans by Modality and Reviewer | Rest: Excellent | 89 participants |
| CTP: 0 - 1 Reversible Defects | Overall Image Quality of Scans by Modality and Reviewer | Stress: Poor | 1 participants |
| CTP: 0 - 1 Reversible Defects | Overall Image Quality of Scans by Modality and Reviewer | Stress: Fair | 4 participants |
| CTP: 0 - 1 Reversible Defects | Overall Image Quality of Scans by Modality and Reviewer | Stress: Good | 16 participants |
| CTP: 0 - 1 Reversible Defects | Overall Image Quality of Scans by Modality and Reviewer | Stress: Excellent | 89 participants |
| CTP: ≥ 2 Reversible Defects | Overall Image Quality of Scans by Modality and Reviewer | Stress: Good | 51 participants |
| CTP: ≥ 2 Reversible Defects | Overall Image Quality of Scans by Modality and Reviewer | Stress: Fair | 24 participants |
| CTP: ≥ 2 Reversible Defects | Overall Image Quality of Scans by Modality and Reviewer | Rest: Excellent | 25 participants |
| CTP: ≥ 2 Reversible Defects | Overall Image Quality of Scans by Modality and Reviewer | Rest: Good | 53 participants |
| CTP: ≥ 2 Reversible Defects | Overall Image Quality of Scans by Modality and Reviewer | Rest: Fair | 31 participants |
| CTP: ≥ 2 Reversible Defects | Overall Image Quality of Scans by Modality and Reviewer | Stress: Poor | 0 participants |
| CTP: ≥ 2 Reversible Defects | Overall Image Quality of Scans by Modality and Reviewer | Rest: Poor | 1 participants |
| CTP: ≥ 2 Reversible Defects | Overall Image Quality of Scans by Modality and Reviewer | Stress: Excellent | 35 participants |
| CTP: All Reversible Defects | Overall Image Quality of Scans by Modality and Reviewer | Rest: Fair | 4 participants |
| CTP: All Reversible Defects | Overall Image Quality of Scans by Modality and Reviewer | Rest: Excellent | 83 participants |
| CTP: All Reversible Defects | Overall Image Quality of Scans by Modality and Reviewer | Rest: Poor | 0 participants |
| CTP: All Reversible Defects | Overall Image Quality of Scans by Modality and Reviewer | Stress: Fair | 5 participants |
| CTP: All Reversible Defects | Overall Image Quality of Scans by Modality and Reviewer | Stress: Good | 27 participants |
| CTP: All Reversible Defects | Overall Image Quality of Scans by Modality and Reviewer | Stress: Excellent | 78 participants |
| CTP: All Reversible Defects | Overall Image Quality of Scans by Modality and Reviewer | Rest: Good | 23 participants |
| CTP: All Reversible Defects | Overall Image Quality of Scans by Modality and Reviewer | Stress: Poor | 0 participants |
| MDCT: Reviewer 1 | Overall Image Quality of Scans by Modality and Reviewer | Stress: Poor | 1 participants |
| MDCT: Reviewer 1 | Overall Image Quality of Scans by Modality and Reviewer | Stress: Excellent | 5 participants |
| MDCT: Reviewer 1 | Overall Image Quality of Scans by Modality and Reviewer | Rest: Good | 56 participants |
| MDCT: Reviewer 1 | Overall Image Quality of Scans by Modality and Reviewer | Stress: Good | 48 participants |
| MDCT: Reviewer 1 | Overall Image Quality of Scans by Modality and Reviewer | Stress: Fair | 56 participants |
| MDCT: Reviewer 1 | Overall Image Quality of Scans by Modality and Reviewer | Rest: Excellent | 30 participants |
| MDCT: Reviewer 1 | Overall Image Quality of Scans by Modality and Reviewer | Rest: Poor | 1 participants |
| MDCT: Reviewer 1 | Overall Image Quality of Scans by Modality and Reviewer | Rest: Fair | 23 participants |
| MDCT: Reviewer 2 | Overall Image Quality of Scans by Modality and Reviewer | Stress: Good | 24 participants |
| MDCT: Reviewer 2 | Overall Image Quality of Scans by Modality and Reviewer | Rest: Good | 37 participants |
| MDCT: Reviewer 2 | Overall Image Quality of Scans by Modality and Reviewer | Stress: Poor | 9 participants |
| MDCT: Reviewer 2 | Overall Image Quality of Scans by Modality and Reviewer | Rest: Excellent | 40 participants |
| MDCT: Reviewer 2 | Overall Image Quality of Scans by Modality and Reviewer | Rest: Fair | 33 participants |
| MDCT: Reviewer 2 | Overall Image Quality of Scans by Modality and Reviewer | Rest: Poor | 0 participants |
| MDCT: Reviewer 2 | Overall Image Quality of Scans by Modality and Reviewer | Stress: Excellent | 15 participants |
| MDCT: Reviewer 2 | Overall Image Quality of Scans by Modality and Reviewer | Stress: Fair | 62 participants |
| MDCT: Reviewer 3 | Overall Image Quality of Scans by Modality and Reviewer | Stress: Excellent | 37 participants |
| MDCT: Reviewer 3 | Overall Image Quality of Scans by Modality and Reviewer | Stress: Poor | 3 participants |
| MDCT: Reviewer 3 | Overall Image Quality of Scans by Modality and Reviewer | Stress: Fair | 34 participants |
| MDCT: Reviewer 3 | Overall Image Quality of Scans by Modality and Reviewer | Rest: Poor | 0 participants |
| MDCT: Reviewer 3 | Overall Image Quality of Scans by Modality and Reviewer | Rest: Fair | 11 participants |
| MDCT: Reviewer 3 | Overall Image Quality of Scans by Modality and Reviewer | Rest: Good | 43 participants |
| MDCT: Reviewer 3 | Overall Image Quality of Scans by Modality and Reviewer | Rest: Excellent | 56 participants |
| MDCT: Reviewer 3 | Overall Image Quality of Scans by Modality and Reviewer | Stress: Good | 36 participants |
Secondary
Percentage of Participants With Two or More Ischemic Segments on SPECT, But Less on CT
Using SPECT as the reference standard, the false negative percentage was calculated as the percentage of participants with two or more ischemic segments on SPECT, but less on CT.
Time frame: Day 1 and Day 2
Population: Full analysis set participants with two or more reversible defects.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| CTP: 0 - 1 Reversible Defects | Percentage of Participants With Two or More Ischemic Segments on SPECT, But Less on CT | 10 percentage of participants |