Coronary Artery Disease
Conditions
Keywords
Coronary Artery Disease., Positron Emission Tomography Myocardial Perfusion Imaging., Single Positron Emission Computed Tomography., Flurpiridaz F18 Injection.
Brief summary
The primary objective of the study is to assess the diagnostic efficacy (specificity and sensitivity) of flurpiridaz F18 injection PET myocardial perfusion imaging (MPI) compared to single photon emission computed tomography (SPECT) MPI in the detection of significant coronary artery disease (CAD) as defined by invasive coronary angiography (ICA) or a documented history of Myocardial Infarction (MI).
Detailed description
The study will assess the diagnostic efficacy (sensitivity and specificity) of Flurpiridaz F18 Injection MPI against SPECT MPI in patients screened for CAD as determined by ICA. Six hundred and eighty evaluable patients will be enrolled and will undergo SPECT MPI and Flurpiridaz F18 PET MPI. Patients will be considered for enrollment if they are scheduled to undergo or have undergone prior ICA without intervention (being either positive or negative for CAD).
Interventions
DRUGFlurpiridaz F18
Injection of Flurpiridaz F18 for the purposes of PET myocardial profusion imaging (MPI) analysis
DRUG99mTechnicium (sestamibi or tetrofosmin)
Injection of 99mTc sestamibi or tetrofosmin for the purposes of SPECT MPI analysis
Sponsors
Lantheus Medical Imaging
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Invasive Coronary Angiography. Men or Women age 18 or older - see protocol for additional details.
Exclusion criteria
Women who are pregnant, lactating, or of child bearing potential who are not practicing birth control. Unstable cardiac status. History of coronary artery bypass graft. History of percutaneous coronary intervention within the past six months. See protocol for additional details.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Diagnostic Efficacy of Flurpiridaz F 18 PET Myocardial Perfusion Imaging (MPI) Sensitivity Versus SPECT Myocardial Perfusion Imaging Sensitivity | 60 days | Diagnostic efficacy of one day rest and stress flurpiridaz F 18 PET MPI sensitivity versus SPECT MPI sensitivity in the detection of coronary artery disease (CAD) by majority rule using invasive coronary angiography as the truth standard, |
| Diagnostic Efficacy of Flurpiridaz PET MPI Specificity Versus SPECT MPI Specificity | 60 days | Diagnostic efficacy of flurpiridaz PET MPI specificity versus SPECT MPI specificity by majority rule in the detection of CAD using invasive coronary angiography as the truth standard |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Diagnostic Performance Evaluation of Localization of CAD for Sensitivity (PETVsSPECT). | 60 days | Overall sensitivity of flurpiridaz F18 PET MPI in coronary territories (Qualitative Diagnosis vs. SPECT MPI by majority rule vs. truth standard (angiographic stenosis greater than or equal to 50% stenosis and confirmed MI); left descending coronary artery (LAD), left circumflex artery (LCX), right coronary artery (RCA), and non - LAD. Value reported is the number of true positives, i.e. True Positive: Patients with abnormal MPI and disease positive by the truth standard |
| Diagnostic Performance Evaluation of Localization of CAD for Specificity (PETVsSPECT). | 60 days | Overall specificity of flurpiridaz F18 PET MPI in Coronary Territories (Qualitative Diagnosis) vs. SPECT MPI by majority rule vs. truth standard (angiographic stenosis greater than or equal to 50% stenosis and confirmed MI); left descending coronary artery (LAD), left circumflex artery (LCX), right coronary artery (RCA), and non - LAD. Value represents the number of true negative, i.e. True Negative: Patients with normal MPI and disease negative by the truth standard |
| Diagnositic Performance Evaluation of Multivessel Disease (PETvsSPECT). | 60 days | Overall summary of sensitivity for identifying multi-vessel disease between flurpiridaz F18 PET MPI and SPECT MPI by majority rule vs. truth standard (angio \>/=50% stenosis and confirmed MI). Value reported is the number of true positives, i.e. True Positive: Patients with abnormal MPI and disease positive by the truth standard |
| Diagnostic Efficacy of Flurpiridaz F18 PET MPI Sensitivity Versus SPECT MPI Sensitivity in Subgroups: Pharmacologic Stress, Females and BMI>/=30. | 60 days | Diagnostic efficacy of flurpiridaz F18 PET MPI sensitivity versus SPECT MPI sensitivity by majority rule in the detection of CAD using invasive coronary angiography as the truth standard, , in subgroups: pharmacologic stress, females and BMI \>/=30. Value reported is the number of true positives, i.e. True Positive: Patients with abnormal MPI and disease positive by the truth standard I |
| Overall Summary of Specificity of PET MPI vs SPECT MPI; Image Quality of Excellent or Good | 60 days | Overall summary of specificity of flurpiridaz F18 PET MPI (qualitative, image quality excellent or good) vs. SPECT MPI by majority rule vs truth standard (angio \>/=50% stenosis and confirmed MI). Value represents the number of true negative, i.e. True Negative: Patients with normal MPI and disease negative by the truth standard |
| Image Quality of Rest and Stress (PET vs SPECT). | 60 days | Overall summary of rest and stress image quality for flurpiridaz F18 PET MPI and SPECT MPI by majority rule. Value represents the number of subject images evaluated as excellent/good and fair/poor |
| Diagnostic Certainty in PET MPI and SPECT MPI | 60 days | Overall summary of diagnostic certainty in flurpiridaz F18 PET MPI and SPECT MPI by majority rule |
| Overall Summary of Sensitivity of PET MPI vs SPECT MPI; Image Quality Excellent or Good | 60 days | Overall summary of sensitivity of flurpiridaz F18 PET MPI (qualitative image quality of excellent or good) vs. SPECT MPI by majority rule vs. truth standard(angio \>/=50% stenosis and confirmed MI). Value reported is the number of true positives, i.e. True Positive: Patients with abnormal MPI and disease positive by the truth standard |
| Diagnostic Efficacy of Flurpiridaz F18 PET MPI Specificity Versus SPECT Specificity in Subgroups: Pharmacologic Stress, Females and BMI>/=30. | 60 days | Diagnostic efficacy of flurpiridaz F18 PET MPI specificity versus SPECT specificity by majority rule in the detection of CAD using invasive coronary angiography as the truth standard, in subgroups: pharmacologic stress, females and BMI \>/=30. Value represents the number of true negative, i.e. True Negative: Patients with normal MPI and disease negative by the truth standard |
Countries
Canada, Finland, Puerto Rico, United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Flurpiridaz F 18 Open-label study of a single dose of Flurpiridaz F18 injection for PET MPI compared to SPECT MPI in patients with suspected or known coronary artery disease referred for coronary catheterization | 795 |
| Total | 795 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Adverse Event | 4 |
| Overall Study | Angio or SPECT not completed | 18 |
| Overall Study | issue with vitals prior to dosing | 1 |
| Overall Study | Lost to Follow-up | 1 |
| Overall Study | Other | 3 |
| Overall Study | Physician Decision | 2 |
| Overall Study | Withdrawal by Subject | 2 |
Baseline characteristics
| Characteristic | Flurpiridaz F 18 |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 337 Participants |
| Age, Categorical Between 18 and 65 years | 458 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 43 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 708 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 44 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 2 Participants |
| Race (NIH/OMB) Asian | 8 Participants |
| Race (NIH/OMB) Black or African American | 105 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 4 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 24 Participants |
| Race (NIH/OMB) White | 652 Participants |
| Sex: Female, Male Female | 249 Participants |
| Sex: Female, Male Male | 546 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 555 / 795 |
| serious Total, serious adverse events | 20 / 795 |
Outcome results
Primary
Diagnostic Efficacy of Flurpiridaz F 18 PET Myocardial Perfusion Imaging (MPI) Sensitivity Versus SPECT Myocardial Perfusion Imaging Sensitivity
Diagnostic efficacy of one day rest and stress flurpiridaz F 18 PET MPI sensitivity versus SPECT MPI sensitivity in the detection of coronary artery disease (CAD) by majority rule using invasive coronary angiography as the truth standard,
Time frame: 60 days
Population: All safety evaluable patients who had rest and stress flurpiridaz F 18 PET MPI and SPECT MPI procedures resulting in evaluable data, and had evaluable invasive coronary angiography
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Flurpiridaz F18 PET MPI | Diagnostic Efficacy of Flurpiridaz F 18 PET Myocardial Perfusion Imaging (MPI) Sensitivity Versus SPECT Myocardial Perfusion Imaging Sensitivity | PET MPI sensitivity | .719 Proportion of true positive cases |
| Flurpiridaz F18 PET MPI | Diagnostic Efficacy of Flurpiridaz F 18 PET Myocardial Perfusion Imaging (MPI) Sensitivity Versus SPECT Myocardial Perfusion Imaging Sensitivity | SPECT MPI Sensitivity | .537 Proportion of true positive cases |
p-value: <0.001McNemar
Primary
Diagnostic Efficacy of Flurpiridaz PET MPI Specificity Versus SPECT MPI Specificity
Diagnostic efficacy of flurpiridaz PET MPI specificity versus SPECT MPI specificity by majority rule in the detection of CAD using invasive coronary angiography as the truth standard
Time frame: 60 days
Population: all safety evaluable patients who had rest and stress flurpiridaz F 18 PET MPI and SPECT MPI procedures resulting in evaluable data and had evaluable invasive coronary angiography
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Flurpiridaz F18 PET MPI | Diagnostic Efficacy of Flurpiridaz PET MPI Specificity Versus SPECT MPI Specificity | PET MPI Specificity | .762 Proportion of true negatives |
| Flurpiridaz F18 PET MPI | Diagnostic Efficacy of Flurpiridaz PET MPI Specificity Versus SPECT MPI Specificity | SPECT MPI Specificity | .868 Proportion of true negatives |
p-value: 0.945Z Test
Secondary
Diagnositic Performance Evaluation of Multivessel Disease (PETvsSPECT).
Overall summary of specificity for identifying multi-vessel disease between flurpiridaz F18 PET MPI and SPECT MPI by majority rule vs. majority rule (angio \>/=50% stenosis and confirmed MI). Value represents the number of true negative, i.e. True Negative: Patients with normal MPI and disease negative by the truth standard
Time frame: 60 days
Population: All safety evaluable patients who had rest and stress flurpiridaz F 18 PET MPI and SPECT MPI procedures resulting in evaluable data, and had evaluable invasive coronary angiography
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Flurpiridaz F18 PET MPI | Diagnositic Performance Evaluation of Multivessel Disease (PETvsSPECT). | PET MPI specificity; multivessel disease | .882 proportion of true negatives |
| Flurpiridaz F18 PET MPI | Diagnositic Performance Evaluation of Multivessel Disease (PETvsSPECT). | SPECT MPI specificity; multivessel disease | .964 proportion of true negatives |
p-value: 0.827z test
Secondary
Diagnositic Performance Evaluation of Multivessel Disease (PETvsSPECT).
Overall summary of sensitivity for identifying multi-vessel disease between flurpiridaz F18 PET MPI and SPECT MPI by majority rule vs. truth standard (angio \>/=50% stenosis and confirmed MI). Value reported is the number of true positives, i.e. True Positive: Patients with abnormal MPI and disease positive by the truth standard
Time frame: 60 days
Population: All safety evaluable patients who had rest and stress flurpiridaz F 18 PET MPI and SPECT MPI procedures resulting in evaluable data, and had evaluable invasive coronary angiography
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Flurpiridaz F18 PET MPI | Diagnositic Performance Evaluation of Multivessel Disease (PETvsSPECT). | PET MPI sensitivity; multivessel disease | .410 proportion of true positives |
| Flurpiridaz F18 PET MPI | Diagnositic Performance Evaluation of Multivessel Disease (PETvsSPECT). | SPECT MPI sensitivity; multivessel disease | .275 proportion of true positives |
p-value: <0.001McNemar
Secondary
Diagnostic Certainty in PET MPI and SPECT MPI
Overall summary of diagnostic certainty in flurpiridaz F18 PET MPI and SPECT MPI by majority rule
Time frame: 60 days
Population: All safety evaluable patients who had rest and stress flurpiridaz F 18 PET MPI and SPECT MPI procedures resulting in evaluable data, and had evaluable invasive coronary angiography
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Flurpiridaz F18 PET MPI | Diagnostic Certainty in PET MPI and SPECT MPI | SPECT probably/equivocal | 0.201 proportion of patients |
| Flurpiridaz F18 PET MPI | Diagnostic Certainty in PET MPI and SPECT MPI | PET definitely normal/abnormal | 0.862 proportion of patients |
| Flurpiridaz F18 PET MPI | Diagnostic Certainty in PET MPI and SPECT MPI | PET probably/equivocal | 0.138 proportion of patients |
| Flurpiridaz F18 PET MPI | Diagnostic Certainty in PET MPI and SPECT MPI | SPECT definitely normal/abnormal | 0.799 proportion of patients |
p-value: <0.001McNemar
Secondary
Diagnostic Efficacy of Flurpiridaz F18 PET MPI Sensitivity Versus SPECT MPI Sensitivity in Subgroups: Pharmacologic Stress, Females and BMI>/=30.
Diagnostic efficacy of flurpiridaz F18 PET MPI sensitivity versus SPECT MPI sensitivity by majority rule in the detection of CAD using invasive coronary angiography as the truth standard, , in subgroups: pharmacologic stress, females and BMI \>/=30. Value reported is the number of true positives, i.e. True Positive: Patients with abnormal MPI and disease positive by the truth standard I
Time frame: 60 days
Population: all safety evaluable patients who had a rest and stress flurpiridaz F18 PET MPI and SPECT MPI procedures resulting in evaluable data and evaluable invasive coronary angiography
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Flurpiridaz F18 PET MPI | Diagnostic Efficacy of Flurpiridaz F18 PET MPI Sensitivity Versus SPECT MPI Sensitivity in Subgroups: Pharmacologic Stress, Females and BMI>/=30. | PET sensitivity pharmacologic stress | 0.736 proportion of true postives |
| Flurpiridaz F18 PET MPI | Diagnostic Efficacy of Flurpiridaz F18 PET MPI Sensitivity Versus SPECT MPI Sensitivity in Subgroups: Pharmacologic Stress, Females and BMI>/=30. | SPECT sensitivity pharmacologic stress | 0.533 proportion of true postives |
| Flurpiridaz F18 PET MPI | Diagnostic Efficacy of Flurpiridaz F18 PET MPI Sensitivity Versus SPECT MPI Sensitivity in Subgroups: Pharmacologic Stress, Females and BMI>/=30. | PET sensitivity in females | 0.644 proportion of true postives |
| Flurpiridaz F18 PET MPI | Diagnostic Efficacy of Flurpiridaz F18 PET MPI Sensitivity Versus SPECT MPI Sensitivity in Subgroups: Pharmacologic Stress, Females and BMI>/=30. | SPECT sensitivity in females | 0.356 proportion of true postives |
| Flurpiridaz F18 PET MPI | Diagnostic Efficacy of Flurpiridaz F18 PET MPI Sensitivity Versus SPECT MPI Sensitivity in Subgroups: Pharmacologic Stress, Females and BMI>/=30. | PET sensitivity BMI >/=30 | 0.722 proportion of true postives |
| Flurpiridaz F18 PET MPI | Diagnostic Efficacy of Flurpiridaz F18 PET MPI Sensitivity Versus SPECT MPI Sensitivity in Subgroups: Pharmacologic Stress, Females and BMI>/=30. | SPECT sensitivity BMI >/=30 | 0.533 proportion of true postives |
p-value: <0.001McNemar
p-value: <0.001McNemar
p-value: <0.001McNemar
Secondary
Diagnostic Efficacy of Flurpiridaz F18 PET MPI Specificity Versus SPECT Specificity in Subgroups: Pharmacologic Stress, Females and BMI>/=30.
Diagnostic efficacy of flurpiridaz F18 PET MPI specificity versus SPECT specificity by majority rule in the detection of CAD using invasive coronary angiography as the truth standard, in subgroups: pharmacologic stress, females and BMI \>/=30. Value represents the number of true negative, i.e. True Negative: Patients with normal MPI and disease negative by the truth standard
Time frame: 60 days
Population: all safety evaluable patients who had a rest and stress flurpiridaz F18 PET MPI and SPECT MPI procedures resulting in evaluable data and evaluable invasive coronary angiography
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Flurpiridaz F18 PET MPI | Diagnostic Efficacy of Flurpiridaz F18 PET MPI Specificity Versus SPECT Specificity in Subgroups: Pharmacologic Stress, Females and BMI>/=30. | PET MPI specificity pharmacological stress | .773 proportion of true negatives |
| Flurpiridaz F18 PET MPI | Diagnostic Efficacy of Flurpiridaz F18 PET MPI Specificity Versus SPECT Specificity in Subgroups: Pharmacologic Stress, Females and BMI>/=30. | SPECT MPI specificity pharmacological stress | .875 proportion of true negatives |
| Flurpiridaz F18 PET MPI | Diagnostic Efficacy of Flurpiridaz F18 PET MPI Specificity Versus SPECT Specificity in Subgroups: Pharmacologic Stress, Females and BMI>/=30. | PET MPI specificity females | .795 proportion of true negatives |
| Flurpiridaz F18 PET MPI | Diagnostic Efficacy of Flurpiridaz F18 PET MPI Specificity Versus SPECT Specificity in Subgroups: Pharmacologic Stress, Females and BMI>/=30. | SPECT MPI specificity females | .869 proportion of true negatives |
| Flurpiridaz F18 PET MPI | Diagnostic Efficacy of Flurpiridaz F18 PET MPI Specificity Versus SPECT Specificity in Subgroups: Pharmacologic Stress, Females and BMI>/=30. | PET MPI specificity BMI >/=30 | .777 proportion of true negatives |
| Flurpiridaz F18 PET MPI | Diagnostic Efficacy of Flurpiridaz F18 PET MPI Specificity Versus SPECT Specificity in Subgroups: Pharmacologic Stress, Females and BMI>/=30. | SPECT MPI specificity BMI >/=30 | .850 proportion of true negatives |
p-value: 0.891Z test
p-value: 0.546z test
p-value: 0.538z test
Secondary
Diagnostic Performance Evaluation of Localization of CAD for Sensitivity (PETVsSPECT).
Overall sensitivity of flurpiridaz F18 PET MPI in coronary territories (Qualitative Diagnosis vs. SPECT MPI by majority rule vs. truth standard (angiographic stenosis greater than or equal to 50% stenosis and confirmed MI); left descending coronary artery (LAD), left circumflex artery (LCX), right coronary artery (RCA), and non - LAD. Value reported is the number of true positives, i.e. True Positive: Patients with abnormal MPI and disease positive by the truth standard
Time frame: 60 days
Population: All safety evaluable patients who had rest and stress flurpiridaz F 18 Flurpiridaz F18 PET MPI and SPECT MPI procedures resulting in evaluable data, and had evaluable invasive coronary angiography
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Flurpiridaz F18 PET MPI | Diagnostic Performance Evaluation of Localization of CAD for Sensitivity (PETVsSPECT). | PET sensitivity Non-LAD | .627 Proportion of true positives |
| Flurpiridaz F18 PET MPI | Diagnostic Performance Evaluation of Localization of CAD for Sensitivity (PETVsSPECT). | SPECT sensitivity Non-LAD | .464 Proportion of true positives |
| Flurpiridaz F18 PET MPI | Diagnostic Performance Evaluation of Localization of CAD for Sensitivity (PETVsSPECT). | PET sensitivity LAD | .495 Proportion of true positives |
| Flurpiridaz F18 PET MPI | Diagnostic Performance Evaluation of Localization of CAD for Sensitivity (PETVsSPECT). | SPECT sensitivity LAD | .333 Proportion of true positives |
| Flurpiridaz F18 PET MPI | Diagnostic Performance Evaluation of Localization of CAD for Sensitivity (PETVsSPECT). | PET sensitivity LCX | .398 Proportion of true positives |
| Flurpiridaz F18 PET MPI | Diagnostic Performance Evaluation of Localization of CAD for Sensitivity (PETVsSPECT). | SPECT sensitivity LCX | .251 Proportion of true positives |
| Flurpiridaz F18 PET MPI | Diagnostic Performance Evaluation of Localization of CAD for Sensitivity (PETVsSPECT). | PET sensitivity RCA | .596 Proportion of true positives |
| Flurpiridaz F18 PET MPI | Diagnostic Performance Evaluation of Localization of CAD for Sensitivity (PETVsSPECT). | SPECT sensitivity RCA | .476 Proportion of true positives |
p-value: <0.001McNemar
p-value: <0.001McNemar
p-value: <0.001McNemar
p-value: <0.001McNemar
Secondary
Diagnostic Performance Evaluation of Localization of CAD for Specificity (PETVsSPECT).
Overall specificity of flurpiridaz F18 PET MPI in Coronary Territories (Qualitative Diagnosis) vs. SPECT MPI by majority rule vs. truth standard (angiographic stenosis greater than or equal to 50% stenosis and confirmed MI); left descending coronary artery (LAD), left circumflex artery (LCX), right coronary artery (RCA), and non - LAD. Value represents the number of true negative, i.e. True Negative: Patients with normal MPI and disease negative by the truth standard
Time frame: 60 days
Population: All safety evaluable patients who had rest and stress flurpiridaz F 18 PET MPI and SPECT MPI procedures resulting in evaluable data, and had evaluable invasive coronary angiography
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Flurpiridaz F18 PET MPI | Diagnostic Performance Evaluation of Localization of CAD for Specificity (PETVsSPECT). | PET specificity LAD | .867 proportion of true negatives |
| Flurpiridaz F18 PET MPI | Diagnostic Performance Evaluation of Localization of CAD for Specificity (PETVsSPECT). | SPECT specificity LCX | .970 proportion of true negatives |
| Flurpiridaz F18 PET MPI | Diagnostic Performance Evaluation of Localization of CAD for Specificity (PETVsSPECT). | SPECT specificity LAD | .932 proportion of true negatives |
| Flurpiridaz F18 PET MPI | Diagnostic Performance Evaluation of Localization of CAD for Specificity (PETVsSPECT). | PET specificity LCX | .904 proportion of true negatives |
| Flurpiridaz F18 PET MPI | Diagnostic Performance Evaluation of Localization of CAD for Specificity (PETVsSPECT). | PET specificity RCA | .845 proportion of true negatives |
| Flurpiridaz F18 PET MPI | Diagnostic Performance Evaluation of Localization of CAD for Specificity (PETVsSPECT). | SPECT specificity RCA | .912 proportion of true negatives |
| Flurpiridaz F18 PET MPI | Diagnostic Performance Evaluation of Localization of CAD for Specificity (PETVsSPECT). | PET specificity Non-LAD | .814 proportion of true negatives |
| Flurpiridaz F18 PET MPI | Diagnostic Performance Evaluation of Localization of CAD for Specificity (PETVsSPECT). | SPECT specificity Non-LAD | .923 proportion of true negatives |
p-value: 0.379z Test
p-value: 0.358Z Test
p-value: 0.442z Test
p-value: 0.984z Test
Secondary
Image Quality of Rest and Stress (PET vs SPECT).
Overall summary of rest and stress image quality for flurpiridaz F18 PET MPI and SPECT MPI by majority rule. Value represents the number of subject images evaluated as excellent/good and fair/poor
Time frame: 60 days
Population: All safety evaluable patients who had rest and stress flurpiridaz F 18 PET MPI and SPECT MPI procedures resulting in evaluable data, and had evaluable invasive coronary angiography
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Flurpiridaz F18 PET MPI | Image Quality of Rest and Stress (PET vs SPECT). | Rest imaging quality PET MPI; excellent/good | .891 percent of images |
| Flurpiridaz F18 PET MPI | Image Quality of Rest and Stress (PET vs SPECT). | Rest image quality SPECT MPI; excellent/good | .739 percent of images |
| Flurpiridaz F18 PET MPI | Image Quality of Rest and Stress (PET vs SPECT). | Stress image quality PET MPI; excellent/good | .976 percent of images |
| Flurpiridaz F18 PET MPI | Image Quality of Rest and Stress (PET vs SPECT). | Stress image quality SPECT MPI; excellent/good | .869 percent of images |
| Flurpiridaz F18 PET MPI | Image Quality of Rest and Stress (PET vs SPECT). | Rest image quality PET MPI; fair/poor | .109 percent of images |
| Flurpiridaz F18 PET MPI | Image Quality of Rest and Stress (PET vs SPECT). | Rest image quality SPECT MPI; fair/poor | .261 percent of images |
| Flurpiridaz F18 PET MPI | Image Quality of Rest and Stress (PET vs SPECT). | stress image quality PET MPI; fair/poor | .024 percent of images |
| Flurpiridaz F18 PET MPI | Image Quality of Rest and Stress (PET vs SPECT). | Stress image quality SPECT MPI; fair/poor | .131 percent of images |
p-value: <0.001Log Rank
Secondary
Overall Summary of Sensitivity of PET MPI vs SPECT MPI; Image Quality Excellent or Good
Overall summary of sensitivity of flurpiridaz F18 PET MPI (qualitative image quality of excellent or good) vs. SPECT MPI by majority rule vs. truth standard(angio \>/=50% stenosis and confirmed MI). Value reported is the number of true positives, i.e. True Positive: Patients with abnormal MPI and disease positive by the truth standard
Time frame: 60 days
Population: All safety evaluable patients who had rest and stress flurpiridaz F 18 PET MPI and SPECT MPI procedures resulting in evaluable data, and had evaluable invasive coronary angiography
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Flurpiridaz F18 PET MPI | Overall Summary of Sensitivity of PET MPI vs SPECT MPI; Image Quality Excellent or Good | PET MPI sensitivity; image quality excellent/good | .711 proportion of true positives |
| Flurpiridaz F18 PET MPI | Overall Summary of Sensitivity of PET MPI vs SPECT MPI; Image Quality Excellent or Good | SPECT MPI sensitivity image quality excellent/good | .539 proportion of true positives |
p-value: <0.001McNemar
Secondary
Overall Summary of Specificity of PET MPI vs SPECT MPI; Image Quality of Excellent or Good
Overall summary of specificity of flurpiridaz F18 PET MPI (qualitative, image quality excellent or good) vs. SPECT MPI by majority rule vs truth standard (angio \>/=50% stenosis and confirmed MI). Value represents the number of true negative, i.e. True Negative: Patients with normal MPI and disease negative by the truth standard
Time frame: 60 days
Population: All safety evaluable patients who had rest and stress flurpiridaz F 18 PET MPI and SPECT MPI procedures resulting in evaluable data, and had evaluable invasive coronary angiography
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Flurpiridaz F18 PET MPI | Overall Summary of Specificity of PET MPI vs SPECT MPI; Image Quality of Excellent or Good | PET MPI specificity; image quality excellent/good | .769 proportion of true negatives |
| Flurpiridaz F18 PET MPI | Overall Summary of Specificity of PET MPI vs SPECT MPI; Image Quality of Excellent or Good | SPECT MPI specificity image quality excellent/good | .880 proportion of true negatives |
p-value: 0.954z Test