Trial Outcomes & Findings for A Phase 3 Multi-center Study to Assess PET Imaging of Flurpiridaz F 18 Injection in Patients With CAD. (NCT NCT01347710)
NCT ID: NCT01347710
Last Updated: 2020-11-24
Results Overview
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,
COMPLETED
PHASE3
795 participants
60 days
2020-11-24
Participant Flow
Participant milestones
| Measure |
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
|
|---|---|
|
Overall Study
STARTED
|
795
|
|
Overall Study
COMPLETED
|
764
|
|
Overall Study
NOT COMPLETED
|
31
|
Reasons for withdrawal
| Measure |
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
|
|---|---|
|
Overall Study
Withdrawal by Subject
|
2
|
|
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
Physician Decision
|
2
|
|
Overall Study
Other
|
3
|
Baseline Characteristics
A Phase 3 Multi-center Study to Assess PET Imaging of Flurpiridaz F 18 Injection in Patients With CAD.
Baseline characteristics by cohort
| Measure |
Flurpiridaz F 18
n=795 Participants
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
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
458 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
337 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
249 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
546 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
43 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
708 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
44 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
8 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
4 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
105 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
652 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
24 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 60 daysPopulation: 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
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,
Outcome measures
| Measure |
Flurpiridaz F18 PET MPI
n=755 Participants
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
Flurpiridaz F18: Injection of Flurpiridaz F18 for the purposes of PET MPI analysis
|
|---|---|
|
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
Interval 0.67 to 0.763
|
|
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
Interval 0.485 to 0.588
|
PRIMARY outcome
Timeframe: 60 daysPopulation: 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
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
Outcome measures
| Measure |
Flurpiridaz F18 PET MPI
n=755 Participants
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
Flurpiridaz F18: Injection of Flurpiridaz F18 for the purposes of PET MPI analysis
|
|---|---|
|
Diagnostic Efficacy of Flurpiridaz PET MPI Specificity Versus SPECT MPI Specificity
PET MPI Specificity
|
.762 Proportion of true negatives
Interval 0.718 to 0.801
|
|
Diagnostic Efficacy of Flurpiridaz PET MPI Specificity Versus SPECT MPI Specificity
SPECT MPI Specificity
|
.868 Proportion of true negatives
Interval 0.832 to 0.898
|
SECONDARY outcome
Timeframe: 60 daysPopulation: 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
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
Outcome measures
| Measure |
Flurpiridaz F18 PET MPI
n=755 Participants
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
Flurpiridaz F18: Injection of Flurpiridaz F18 for the purposes of PET MPI analysis
|
|---|---|
|
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
Interval 0.679 to 0.785
|
|
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
Interval 0.472 to 0.592
|
|
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
Interval 0.517 to 0.754
|
|
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
Interval 0.246 to 0.483
|
|
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
Interval 0.653 to 0.782
|
|
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
Interval 0.461 to 0.605
|
SECONDARY outcome
Timeframe: 60 daysPopulation: 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
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
Outcome measures
| Measure |
Flurpiridaz F18 PET MPI
n=755 Participants
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
Flurpiridaz F18: Injection of Flurpiridaz F18 for the purposes of PET MPI analysis
|
|---|---|
|
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
Interval 0.72 to 0.819
|
|
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
Interval 0.831 to 0.909
|
|
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
Interval 0.73 to 0.848
|
|
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
Interval 0.812 to 0.911
|
|
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
Interval 0.719 to 0.826
|
|
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
Interval 0.798 to 0.89
|
SECONDARY outcome
Timeframe: 60 daysPopulation: 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
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
Outcome measures
| Measure |
Flurpiridaz F18 PET MPI
n=755 Participants
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
Flurpiridaz F18: Injection of Flurpiridaz F18 for the purposes of PET MPI analysis
|
|---|---|
|
Diagnostic Performance Evaluation of Localization of CAD for Sensitivity (PETVsSPECT).
PET sensitivity LAD
|
.495 Proportion of true positives
Interval 0.43 to 0.561
|
|
Diagnostic Performance Evaluation of Localization of CAD for Sensitivity (PETVsSPECT).
SPECT sensitivity LAD
|
.333 Proportion of true positives
Interval 0.275 to 0.398
|
|
Diagnostic Performance Evaluation of Localization of CAD for Sensitivity (PETVsSPECT).
PET sensitivity LCX
|
.398 Proportion of true positives
Interval 0.331 to 0.469
|
|
Diagnostic Performance Evaluation of Localization of CAD for Sensitivity (PETVsSPECT).
SPECT sensitivity LCX
|
.251 Proportion of true positives
Interval 0.195 to 0.317
|
|
Diagnostic Performance Evaluation of Localization of CAD for Sensitivity (PETVsSPECT).
PET sensitivity RCA
|
.596 Proportion of true positives
Interval 0.528 to 0.661
|
|
Diagnostic Performance Evaluation of Localization of CAD for Sensitivity (PETVsSPECT).
SPECT sensitivity RCA
|
.476 Proportion of true positives
Interval 0.409 to 0.544
|
|
Diagnostic Performance Evaluation of Localization of CAD for Sensitivity (PETVsSPECT).
PET sensitivity Non-LAD
|
.627 Proportion of true positives
Interval 0.568 to 0.682
|
|
Diagnostic Performance Evaluation of Localization of CAD for Sensitivity (PETVsSPECT).
SPECT sensitivity Non-LAD
|
.464 Proportion of true positives
Interval 0.406 to 0.523
|
SECONDARY outcome
Timeframe: 60 daysPopulation: 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
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
Outcome measures
| Measure |
Flurpiridaz F18 PET MPI
n=755 Participants
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
Flurpiridaz F18: Injection of Flurpiridaz F18 for the purposes of PET MPI analysis
|
|---|---|
|
Diagnostic Performance Evaluation of Localization of CAD for Specificity (PETVsSPECT).
PET specificity LAD
|
.867 proportion of true negatives
Interval 0.835 to 0.893
|
|
Diagnostic Performance Evaluation of Localization of CAD for Specificity (PETVsSPECT).
SPECT specificity LAD
|
.932 proportion of true negatives
Interval 0.908 to 0.951
|
|
Diagnostic Performance Evaluation of Localization of CAD for Specificity (PETVsSPECT).
PET specificity LCX
|
.904 proportion of true negatives
Interval 0.877 to 0.926
|
|
Diagnostic Performance Evaluation of Localization of CAD for Specificity (PETVsSPECT).
SPECT specificity LCX
|
.970 proportion of true negatives
Interval 0.952 to 0.981
|
|
Diagnostic Performance Evaluation of Localization of CAD for Specificity (PETVsSPECT).
PET specificity RCA
|
.845 proportion of true negatives
Interval 0.812 to 0.873
|
|
Diagnostic Performance Evaluation of Localization of CAD for Specificity (PETVsSPECT).
SPECT specificity RCA
|
.912 proportion of true negatives
Interval 0.886 to 0.933
|
|
Diagnostic Performance Evaluation of Localization of CAD for Specificity (PETVsSPECT).
PET specificity Non-LAD
|
.814 proportion of true negatives
Interval 0.777 to 0.846
|
|
Diagnostic Performance Evaluation of Localization of CAD for Specificity (PETVsSPECT).
SPECT specificity Non-LAD
|
.923 proportion of true negatives
Interval 0.895 to 0.943
|
SECONDARY outcome
Timeframe: 60 daysPopulation: 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
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
Outcome measures
| Measure |
Flurpiridaz F18 PET MPI
n=755 Participants
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
Flurpiridaz F18: Injection of Flurpiridaz F18 for the purposes of PET MPI analysis
|
|---|---|
|
Diagnositic Performance Evaluation of Multivessel Disease (PETvsSPECT).
PET MPI sensitivity; multivessel disease
|
.410 proportion of true positives
Interval 0.34 to 0.484
|
|
Diagnositic Performance Evaluation of Multivessel Disease (PETvsSPECT).
SPECT MPI sensitivity; multivessel disease
|
.275 proportion of true positives
Interval 0.215 to 0.345
|
SECONDARY outcome
Timeframe: 60 daysPopulation: 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
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
Outcome measures
| Measure |
Flurpiridaz F18 PET MPI
n=755 Participants
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
Flurpiridaz F18: Injection of Flurpiridaz F18 for the purposes of PET MPI analysis
|
|---|---|
|
Diagnositic Performance Evaluation of Multivessel Disease (PETvsSPECT).
PET MPI specificity; multivessel disease
|
.882 proportion of true negatives
Interval 0.853 to 0.906
|
|
Diagnositic Performance Evaluation of Multivessel Disease (PETvsSPECT).
SPECT MPI specificity; multivessel disease
|
.964 proportion of true negatives
Interval 0.945 to 0.976
|
SECONDARY outcome
Timeframe: 60 daysPopulation: 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
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
Outcome measures
| Measure |
Flurpiridaz F18 PET MPI
n=755 Participants
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
Flurpiridaz F18: Injection of Flurpiridaz F18 for the purposes of PET MPI analysis
|
|---|---|
|
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
Interval 0.658 to 0.759
|
|
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
Interval 0.483 to 0.594
|
SECONDARY outcome
Timeframe: 60 daysPopulation: 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
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
Outcome measures
| Measure |
Flurpiridaz F18 PET MPI
n=755 Participants
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
Flurpiridaz F18: Injection of Flurpiridaz F18 for the purposes of PET MPI analysis
|
|---|---|
|
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
Interval 0.721 to 0.811
|
|
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
Interval 0.841 to 0.911
|
SECONDARY outcome
Timeframe: 60 daysPopulation: 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
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
Outcome measures
| Measure |
Flurpiridaz F18 PET MPI
n=755 Participants
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
Flurpiridaz F18: Injection of Flurpiridaz F18 for the purposes of PET MPI analysis
|
|---|---|
|
Image Quality of Rest and Stress (PET vs SPECT).
Rest image quality PET MPI; fair/poor
|
.109 percent of images
|
|
Image Quality of Rest and Stress (PET vs SPECT).
Stress image quality SPECT MPI; excellent/good
|
.869 percent of images
|
|
Image Quality of Rest and Stress (PET vs SPECT).
Rest imaging quality PET MPI; excellent/good
|
.891 percent of images
|
|
Image Quality of Rest and Stress (PET vs SPECT).
Rest image quality SPECT MPI; excellent/good
|
.739 percent of images
|
|
Image Quality of Rest and Stress (PET vs SPECT).
Stress image quality PET MPI; excellent/good
|
.976 percent of images
|
|
Image Quality of Rest and Stress (PET vs SPECT).
Rest image quality SPECT MPI; fair/poor
|
.261 percent of images
|
|
Image Quality of Rest and Stress (PET vs SPECT).
stress image quality PET MPI; fair/poor
|
.024 percent of images
|
|
Image Quality of Rest and Stress (PET vs SPECT).
Stress image quality SPECT MPI; fair/poor
|
.131 percent of images
|
SECONDARY outcome
Timeframe: 60 daysPopulation: 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
Overall summary of diagnostic certainty in flurpiridaz F18 PET MPI and SPECT MPI by majority rule
Outcome measures
| Measure |
Flurpiridaz F18 PET MPI
n=755 Participants
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
Flurpiridaz F18: Injection of Flurpiridaz F18 for the purposes of PET MPI analysis
|
|---|---|
|
Diagnostic Certainty in PET MPI and SPECT MPI
PET definitely normal/abnormal
|
0.862 proportion of patients
|
|
Diagnostic Certainty in PET MPI and SPECT MPI
PET probably/equivocal
|
0.138 proportion of patients
|
|
Diagnostic Certainty in PET MPI and SPECT MPI
SPECT definitely normal/abnormal
|
0.799 proportion of patients
|
|
Diagnostic Certainty in PET MPI and SPECT MPI
SPECT probably/equivocal
|
0.201 proportion of patients
|
Adverse Events
Flurpiridaz F 18
Serious adverse events
| Measure |
Flurpiridaz F 18
n=795 participants at risk
Open-label study of a single dose Flurpiridaz F18 injection for PET MPI compared to SPECT MPI in patients with suspected or known coronary artery disease referred for coronary catheterization
|
|---|---|
|
Cardiac disorders
Angina Pectoris
|
0.75%
6/795 • Number of events 6 • Adverse events occurring from the time of flurpiridaz F 18 rest administration through 14-17 day safety follow up
Affected represents patients with at least one serious adverse event and/or adverse event
|
|
Cardiac disorders
Atrial Flutter
|
0.13%
1/795 • Number of events 1 • Adverse events occurring from the time of flurpiridaz F 18 rest administration through 14-17 day safety follow up
Affected represents patients with at least one serious adverse event and/or adverse event
|
|
Cardiac disorders
Cardiac Failure Congestive
|
0.13%
1/795 • Number of events 1 • Adverse events occurring from the time of flurpiridaz F 18 rest administration through 14-17 day safety follow up
Affected represents patients with at least one serious adverse event and/or adverse event
|
|
Cardiac disorders
Cardiogenic Shock
|
0.13%
1/795 • Number of events 1 • Adverse events occurring from the time of flurpiridaz F 18 rest administration through 14-17 day safety follow up
Affected represents patients with at least one serious adverse event and/or adverse event
|
|
Cardiac disorders
Ventricular Tachycardia
|
0.25%
2/795 • Number of events 2 • Adverse events occurring from the time of flurpiridaz F 18 rest administration through 14-17 day safety follow up
Affected represents patients with at least one serious adverse event and/or adverse event
|
|
Gastrointestinal disorders
Inguinal Hernia
|
0.13%
1/795 • Number of events 1 • Adverse events occurring from the time of flurpiridaz F 18 rest administration through 14-17 day safety follow up
Affected represents patients with at least one serious adverse event and/or adverse event
|
|
General disorders
Catheter Site Haemorrhage
|
0.13%
1/795 • Number of events 1 • Adverse events occurring from the time of flurpiridaz F 18 rest administration through 14-17 day safety follow up
Affected represents patients with at least one serious adverse event and/or adverse event
|
|
General disorders
Non-Cardiac Chest Pain
|
0.13%
1/795 • Number of events 1 • Adverse events occurring from the time of flurpiridaz F 18 rest administration through 14-17 day safety follow up
Affected represents patients with at least one serious adverse event and/or adverse event
|
|
Infections and infestations
Pneumonia
|
0.13%
1/795 • Number of events 1 • Adverse events occurring from the time of flurpiridaz F 18 rest administration through 14-17 day safety follow up
Affected represents patients with at least one serious adverse event and/or adverse event
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
0.13%
1/795 • Number of events 1 • Adverse events occurring from the time of flurpiridaz F 18 rest administration through 14-17 day safety follow up
Affected represents patients with at least one serious adverse event and/or adverse event
|
|
Nervous system disorders
Dizziness
|
0.13%
1/795 • Number of events 1 • Adverse events occurring from the time of flurpiridaz F 18 rest administration through 14-17 day safety follow up
Affected represents patients with at least one serious adverse event and/or adverse event
|
|
Nervous system disorders
Headache
|
0.13%
1/795 • Number of events 1 • Adverse events occurring from the time of flurpiridaz F 18 rest administration through 14-17 day safety follow up
Affected represents patients with at least one serious adverse event and/or adverse event
|
|
Respiratory, thoracic and mediastinal disorders
Chronic Obstructive Pulmonary Disease
|
0.13%
1/795 • Number of events 1 • Adverse events occurring from the time of flurpiridaz F 18 rest administration through 14-17 day safety follow up
Affected represents patients with at least one serious adverse event and/or adverse event
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.13%
1/795 • Number of events 1 • Adverse events occurring from the time of flurpiridaz F 18 rest administration through 14-17 day safety follow up
Affected represents patients with at least one serious adverse event and/or adverse event
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary Embolism
|
0.13%
1/795 • Number of events 1 • Adverse events occurring from the time of flurpiridaz F 18 rest administration through 14-17 day safety follow up
Affected represents patients with at least one serious adverse event and/or adverse event
|
|
Vascular disorders
Hypotension
|
0.13%
1/795 • Number of events 1 • Adverse events occurring from the time of flurpiridaz F 18 rest administration through 14-17 day safety follow up
Affected represents patients with at least one serious adverse event and/or adverse event
|
|
Vascular disorders
Peripheral Arterial Occlusive Disease
|
0.13%
1/795 • Number of events 1 • Adverse events occurring from the time of flurpiridaz F 18 rest administration through 14-17 day safety follow up
Affected represents patients with at least one serious adverse event and/or adverse event
|
Other adverse events
| Measure |
Flurpiridaz F 18
n=795 participants at risk
Open-label study of a single dose Flurpiridaz F18 injection for PET MPI compared to SPECT MPI in patients with suspected or known coronary artery disease referred for coronary catheterization
|
|---|---|
|
Cardiac disorders
Angina Pectoris
|
15.0%
119/795 • Number of events 119 • Adverse events occurring from the time of flurpiridaz F 18 rest administration through 14-17 day safety follow up
Affected represents patients with at least one serious adverse event and/or adverse event
|
|
Gastrointestinal disorders
Nausea
|
5.5%
44/795 • Number of events 44 • Adverse events occurring from the time of flurpiridaz F 18 rest administration through 14-17 day safety follow up
Affected represents patients with at least one serious adverse event and/or adverse event
|
|
General disorders
Fatigue
|
8.8%
70/795 • Number of events 70 • Adverse events occurring from the time of flurpiridaz F 18 rest administration through 14-17 day safety follow up
Affected represents patients with at least one serious adverse event and/or adverse event
|
|
General disorders
Non-Cardiac Chest Pain
|
7.3%
58/795 • Number of events 58 • Adverse events occurring from the time of flurpiridaz F 18 rest administration through 14-17 day safety follow up
Affected represents patients with at least one serious adverse event and/or adverse event
|
|
Investigations
Electrocardiogram ST Segment Depressions
|
9.4%
75/795 • Number of events 75 • Adverse events occurring from the time of flurpiridaz F 18 rest administration through 14-17 day safety follow up
Affected represents patients with at least one serious adverse event and/or adverse event
|
|
Nervous system disorders
Dizziness
|
5.4%
43/795 • Number of events 43 • Adverse events occurring from the time of flurpiridaz F 18 rest administration through 14-17 day safety follow up
Affected represents patients with at least one serious adverse event and/or adverse event
|
|
Nervous system disorders
Headache
|
16.2%
129/795 • Number of events 129 • Adverse events occurring from the time of flurpiridaz F 18 rest administration through 14-17 day safety follow up
Affected represents patients with at least one serious adverse event and/or adverse event
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
25.2%
200/795 • Number of events 200 • Adverse events occurring from the time of flurpiridaz F 18 rest administration through 14-17 day safety follow up
Affected represents patients with at least one serious adverse event and/or adverse event
|
|
Vascular disorders
Flushing
|
7.5%
60/795 • Number of events 60 • Adverse events occurring from the time of flurpiridaz F 18 rest administration through 14-17 day safety follow up
Affected represents patients with at least one serious adverse event and/or adverse event
|
|
Surgical and medical procedures
Percutaneous coronary intervention
|
9.1%
72/795 • Number of events 72 • Adverse events occurring from the time of flurpiridaz F 18 rest administration through 14-17 day safety follow up
Affected represents patients with at least one serious adverse event and/or adverse event
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60