An International Study to Evaluate Diagnostic Efficacy of Flurpiridaz (18F) Injection PET MPI in the Detection of Coronary Artery Disease (CAD)

Phase 3

Completed

Conditions: Coronary Artery Disease (CAD)

Interventions: Drug: PET MPI
Drug: SPECT MPI
Drug: Pharmacological stress agents

Registration Number: NCT03354273

Lead Sponsor: GE Healthcare

Brief Summary: This is a Phase 3, prospective, open-label, international, multicentre study of Flurpiridaz (18F) Injection for PET MPI in patients referred for ICA because of suspected CAD.

Detailed Description: Not available

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 730

Inclusion Criteria

The participant was a man or woman ≥18 years of age.
The participant had read, signed, and dated an informed consent form (ICF) prior to any study procedures being performed.
At the time of enrolment, the participant had been scheduled via written documentation to undergo an ICA for the assessment of CAD.
The participant had undergone a clinically indicated SPECT OR the participant was willing to undergo SPECT MPI for the purposes of the clinical study.
The participant was male or was a nonpregnant, nonlactating female who was either surgically sterile or was post-menopausal.
The participant was able and willing to comply with all study procedures as described in the protocol.

Exclusion Criteria

Participants who were pregnant, may possibly be pregnant, or wish (including their partners) to became pregnant during the study period, or were lactating.
Participants who were unable to undergo all of the imaging procedures.
Participants who had an established diagnosis of CAD as confirmed by any of the following:
1. Previous myocardial infarction (MI);
2. Previous cardiac catheter angiography showing ≥50% stenosis;
3. Previous coronary revascularisation, such as percutaneous coronary intervention (PCI), thrombolysis or coronary artery bypass graft (CABG) placement.
Participants incapable of undergoing either exercise or pharmacological cardiac stress testing.
Participants who had a current illness or pathology that, in the opinion of the investigator, would pose a significant safety risk for the participant during cardiac stress testing.
Documented history of heart failure and/or cardiomyopathy and/or prior LV ejection fraction (LVEF) <50%).
Participants scheduled for or planning to undergo any cardiac interventional procedures between enrolment and ICA.
Participants undergoing evaluation for heart transplantation or with history of heart transplantation.
Participants enrolled in another clinical study within the 30 days prior to being enrolled in this study or scheduled to participate in another clinical study during the 7-day follow-up period of this study.

Study & Design

Study Type: INTERVENTIONAL

Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
1	Pharmacological stress agents	Flurpiridaz PET MPI (following off-study SPECT MPI)
1	SPECT MPI	Flurpiridaz PET MPI (following off-study SPECT MPI)
1	PET MPI	Flurpiridaz PET MPI (following off-study SPECT MPI)

Primary Outcome Measures

Name	Time	Method
Sensitivity and Specificity of Flurpiridaz (18F) Injection Positron Emission Tomography (PET) Myocardial Perfusion Imaging (MPI) in the Detection of Significant Coronary Artery Disease (CAD) as Defined by Cardiac Catheterization	Up to 60 days	Sensitivity was defined as true positives (TP)/(TP+false negatives \[FN\]). TP was participants with abnormal PET MPI and disease positive by truth standard and FN was participants with normal PET MPI and disease positive by truth standard. Specificity defined as true negatives (TN)/(TN+ false positives \[FP\]). TN was participants with normal PET MPI and disease negative by truth standard and FP was participants with abnormal PET MPI and disease negative by truth standard. Truth standard was presence of CAD as evidenced by presence of stenosis of \>=50 percent (%) in \>=1 coronary artery or major branch of a coronary artery as determined by quantitative coronary angiography (QCA) analysis. Participants were considered to have CAD if QCA revealed \>=50% stenosis of \>=1 major coronary artery or major branch. Sensitivity and specificity were calculated for 3 readers and majority rule using each participant judgement (positive or negative) by at least 2 of 3 readers.

Secondary Outcome Measures

Name	Time	Method
Sensitivity and Specificity of Flurpiridaz (18F) Injection PET MPI Compared SPECT MPI for All Participants When the Diagnosis of CAD by ICA Was the Standard of Truth	Up to 60 days	Sensitivity:TP/(TP+FN). TP:participants with abnormal PET MPI and disease positive by truth standard and FN:participants with normal PET MPI and disease positive by truth standard. Specificity:TN/(TN+ FP). TN:participants with normal PET MPI and disease negative by truth standard and FP:participants with abnormal PET MPI and disease negative by truth standard. Truth standard was presence of CAD as evidenced by presence of stenosis of \>=50% in \>=1 coronary artery or major branch of coronary artery as determined by QCA analysis. Participants considered to have CAD if QCA revealed \>=50% stenosis of \>=1 major coronary artery or major branch. Sensitivity, specificity was calculated for 3 readers and majority rule using each participant judgement (positive or negative) by at least 2 of 3 readers. Sensitivity, specificity of Flurpiridaz (18F) PET MPI compared to SPECT MPI with QCA as standard of truth at \>=50% stenosis threshold for all participants was reported by reader and majority rule.
Sensitivity and Specificity of Flurpiridaz (18F) Injection PET MPI Compared SPECT MPI for Female Participants When the Diagnosis of CAD by ICA Was the Standard of Truth	Up to 60 days	Sensitivity:TP/(TP+FN). TP:participants with abnormal PET MPI and disease positive by truth standard and FN:participants with normal PET MPI and disease positive by truth standard. Specificity:TN/(TN+ FP). TN:participants with normal PET MPI and disease negative by truth standard and FP:participants with abnormal PET MPI and disease negative by truth standard. Truth standard was presence of CAD as evidenced by presence of stenosis of \>=50% in \>=1 coronary artery or major branch of a coronary artery as determined by QCA analysis. Participants considered to have CAD if QCA revealed \>=50% stenosis of \>=1 major coronary artery or major branch. Sensitivity, specificity calculated for 3 readers and majority rule using each participant judgement (positive or negative) by at least 2 of 3 readers. Sensitivity, specificity of Flurpiridaz (18F) PET MPI compared to SPECT MPI with QCA as standard of truth at \>=50% stenosis threshold for female participants was reported by reader and majority rule.
Sensitivity and Specificity of Flurpiridaz (18F) Injection PET MPI Compared SPECT MPI for Participants With Body-mass Index (BMI) >=30 Kilograms Per Square Meter (kg/m^2) When the Diagnosis of CAD by ICA Was the Standard of Truth	Up to 60 days	Sensitivity:TP/(TP+FN). TP:participants with abnormal PET MPI and disease positive by truth standard and FN:participants with normal PET MPI and disease positive by truth standard. Specificity:TN/(TN+ FP). TN:participants with normal PET MPI and disease negative by truth standard and FP:participants with abnormal PET MPI and disease negative by truth standard. Truth standard was presence of CAD as evidenced by presence of stenosis of \>=50% in \>=1 coronary artery or major branch of coronary artery determined by QCA analysis. Participants considered to have CAD if QCA revealed \>=50% stenosis of \>=1 major coronary artery or major branch. Sensitivity, specificity calculated for 3 readers and majority rule using each participant judgement (positive or negative) by at least 2 of 3 readers. Sensitivity, specificity of Flurpiridaz (18F) PET MPI compared to SPECT MPI with QCA as standard of truth at \>=50% stenosis threshold for participants(BMI\>=30 kg/m\^2) reported by reader and majority rule.
Sensitivity and Specificity of Flurpiridaz (18F) Injection PET MPI Compared SPECT MPI for Diabetic Participants When the Diagnosis of CAD by ICA Was the Standard of Truth	Up to 60 days	Sensitivity:TP/(TP+FN). TP:participants with abnormal PET MPI and disease positive by truth standard and FN:participants with normal PET MPI and disease positive by truth standard. Specificity:TN/(TN+ FP). TN:participants with normal PET MPI and disease negative by truth standard and FP:participants with abnormal PET MPI and disease negative by truth standard. Truth standard was presence of CAD as evidenced by presence of stenosis of \>=50% in \>=1 coronary artery or major branch of coronary artery determined by QCA analysis. Participants considered to have CAD if QCA revealed \>=50% stenosis of \>=1 major coronary artery or major branch. Sensitivity and specificity calculated for 3 readers and majority rule using each participant judgement (positive or negative) by at least 2 of 3 readers. Sensitivity, specificity of Flurpiridaz (18F) PET MPI compared to SPECT MPI with QCA as standard of truth at \>=50% stenosis threshold for diabetic participants was reported by reader and majority rule.

Trial Locations

Locations (53): Vascular Biology and Hypertension Program, University of Alabama at Birmingham
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Birmingham, Alabama, United States
University of California- Los Angeles
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Los Angeles, California, United States
Keck Hospital of USC
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Los Angeles, California, United States
VA Greater Los Angeles Health Care System
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Los Angeles, California, United States
VA San Diego Health System
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San Diego, California, United States
UCSF
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San Francisco, California, United States
Tower Saint John's Imaging
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Santa Monica, California, United States
Yale New Haven Hospital
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New Haven, Connecticut, United States
Cardiology Physicians PA/Red Clay Research LLC
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Newark, Delaware, United States
University of Florida
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Gainesville, Florida, United States
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Vascular Biology and Hypertension Program, University of Alabama at Birmingham
🇺🇸Birmingham, Alabama, United States