Back to resultsAn International Study to Evaluate Diagnostic Efficacy of Flurpiridaz (18F) Injection PET MPI in the Detection of Coronary Artery Disease (CAD)
Primary Purpose
Coronary Artery Disease (CAD)
Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
PET MPI
SPECT MPI
Pharmacological stress agents
Sponsored by
About this trial
This is an interventional diagnostic trial for Coronary Artery Disease (CAD) focused on measuring Positron emission tomography myocardial perfusion imaging (PET MPI), Single photon emission computed tomography myocardial perfusion imaging (SPECT MPI), Invasive coronary angiography (ICA), Coronary artery disease (CAD)
Eligibility Criteria
Inclusion Criteria:
- The subject is a man or woman ≥18 years of age.
- The subject has read, signed, and dated an informed consent form (ICF) prior to any study procedures being performed.
- At the time of enrolment, the subject has been scheduled via written documentation to undergo an ICA for the assessment of CAD.
- The subject has undergone a clinically indicated SPECT OR the patient is willing to undergo SPECT MPI for the purposes of the clinical study.
- The subject is male or is a nonpregnant, nonlactating female who is either surgically sterile or is post-menopausal.
- The subject is able and willing to comply with all study procedures as described in the protocol.
Exclusion Criteria:
- Patients who are pregnant, may possibly be pregnant, or wish (including their partners) to become pregnant during the study period, or are lactating.
- Patients who are unable to undergo all of the imaging procedures.
Patients who have an established diagnosis of CAD as confirmed by any of the following:
- Previous myocardial infarction (MI);
- Previous cardiac catheter angiography showing ≥50% stenosis;
- Previous coronary revascularisation, such as percutaneous coronary intervention (PCI), thrombolysis or coronary artery bypass graft (CABG) placement.
- Patients incapable of undergoing either exercise or pharmacological cardiac stress testing.
- Patients who have a current illness or pathology that, in the opinion of the investigator, would pose a significant safety risk for the patient during cardiac stress testing.
- Documented history of heart failure and/or cardiomyopathy and/or prior LV ejection fraction (LVEF) <50%).
- Patients scheduled for or planning to undergo any cardiac interventional procedures between enrolment and ICA.
- Patients undergoing evaluation for heart transplantation or with history of heart transplantation.
- Patients 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.
Sites / Locations
- Vascular Biology and Hypertension Program, University of Alabama at Birmingham
- University of California- Los Angeles
- Keck Hospital of USC
- VA Greater Los Angeles Health Care System
- VA San Diego Health System
- UCSF
- Tower Saint John's Imaging
- Yale New Haven Hospital
- Cardiology Physicians PA/Red Clay Research LLC
- University of Florida
- Indago Research and Health Center
- Optimus U Corp
- Infinite Clinical Research
- Allied Biomedical Research Institute
- Comprehensive Vascular Care PA
- Amavita Clinical Research, LLC
- Emory University
- University Of Iowa Hospitals And Clinics
- Midwest Heart and Vascular Specialists
- Ochsner Clinic Foundation
- Saint Luke's Hospital of Kansas City
- VA St. Louis Health Care System
- St Louis University
- Washington University School of Medicine
- Columbia University Medical Center/New York Presbyterian Hospital - Milstein Hospital Building
- University of Cincinnati Medical Center
- OhioHealth Research Institute
- University of Pennsylvania
- Berks Cardiologists, LTD
- University of Tennessee Medical Center
- VA North Texas Health Care System - NAVREF - PPDS
- University of Texas Southwestern Medical Center
- The Methodist Hospital Research Institute
- Vital Heart & Vein
- Memorial City and Katy Cardiology Associates
- University of Virginia Health System
- Roanoke Heart Institute
- University of Ottawa Heart Institute
- Center Hospitalier Universitaire de Sherbrooke CHUS
- Montreal Heart Institute
- Turku University Hospital
- Hopital Cote de Nacre
- Groupe Hospitalier Bichat Claude Bernard
- Centre Cardiologique Du Nord
- Universitätsklinikum der RWTH Aachen
- Universitätsklinikum Essen
- VU Medisch Centrum
- Amphia Ziekenhuis - WCN - PPDS
- Catharina Hospital
- Zuyderland Medisch Centrum-WCN-PPDS
- Leids Universitair Medisch Centrum
- Hopitaux Universitaires de Geneve
- Universitatsspital Zurich
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
1
Arm Description
Flurpiridaz PET MPI (following off-study SPECT MPI)
Outcomes
Primary Outcome Measures
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
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
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
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
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
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
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.
Full Information
NCT ID
NCT03354273
First Posted
November 21, 2017
Last Updated
June 19, 2023
Sponsor
GE Healthcare
Collaborators
Pharmaceutical Product Development, LLC
1. Study Identification
Unique Protocol Identification Number
NCT03354273
Brief Title
An International Study to Evaluate Diagnostic Efficacy of Flurpiridaz (18F) Injection PET MPI in the Detection of Coronary Artery Disease (CAD)
Official Title
A Phase 3, Open-Label, Multicentre Study of Flurpiridaz (18F) Injection for Positron Emission Tomography (PET) Imaging for Assessment of Myocardial Perfusion in Patients Referred for Invasive Coronary Angiography Because of Suspected Coronary Artery Disease
Study Type
Interventional
2. Study Status
Record Verification Date
June 2023
Overall Recruitment Status
Completed
Study Start Date
June 5, 2018 (Actual)
Primary Completion Date
May 5, 2022 (Actual)
Study Completion Date
May 5, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
GE Healthcare
Collaborators
Pharmaceutical Product Development, LLC
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Coronary Artery Disease (CAD)
Keywords
Positron emission tomography myocardial perfusion imaging (PET MPI), Single photon emission computed tomography myocardial perfusion imaging (SPECT MPI), Invasive coronary angiography (ICA), Coronary artery disease (CAD)
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
730 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Experimental
Arm Description
Flurpiridaz PET MPI (following off-study SPECT MPI)
Intervention Type
Drug
Intervention Name(s)
PET MPI
Intervention Description
Flurpiridaz (18F) Injection. All participants received 2 IV boluses of Flurpiridaz (18F) Injection in a large peripheral vein: 1 at rest and 1 during stress. The dosages of Flurpiridaz (18F) Injection administered at rest and during stress conditions did not exceed a total of 14 mCi (520 MBq) for an individual participant.
Intervention Type
Drug
Intervention Name(s)
SPECT MPI
Intervention Description
SPECT imaging was used 99mTc-based myocardial tracers. SPECT agents utilised for the purposes of this clinical study was administered as per American Society of Nuclear Cardiology or European Association of Cardiovascular Imaging standards, where applicable. All participants undergone SPECT MPI.
Intervention Type
Drug
Intervention Name(s)
Pharmacological stress agents
Intervention Description
Pharmacologic stress agents were restricted to the following 3 agents, as permitted by local marketing authorisations and availability: adenosine, dipyridamole, and regadenoson. Administration was through an IV line.
Primary Outcome Measure Information:
Title
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
Description
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.
Time Frame
Up to 60 days
Secondary Outcome Measure Information:
Title
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
Description
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.
Time Frame
Up to 60 days
Title
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
Description
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.
Time Frame
Up to 60 days
Title
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
Description
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.
Time Frame
Up to 60 days
Title
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
Description
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.
Time Frame
Up to 60 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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:
Previous myocardial infarction (MI);
Previous cardiac catheter angiography showing ≥50% stenosis;
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Francois Tranquart, M.D., Ph.D.
Organizational Affiliation
General Electric Healthcare Life Sciences
Official's Role
Study Director
Facility Information:
Facility Name
Vascular Biology and Hypertension Program, University of Alabama at Birmingham
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35294
Country
United States
Facility Name
University of California- Los Angeles
City
Los Angeles
State/Province
California
ZIP/Postal Code
90024
Country
United States
Facility Name
Keck Hospital of USC
City
Los Angeles
State/Province
California
ZIP/Postal Code
90033
Country
United States
Facility Name
VA Greater Los Angeles Health Care System
City
Los Angeles
State/Province
California
ZIP/Postal Code
90073
Country
United States
Facility Name
VA San Diego Health System
City
San Diego
State/Province
California
ZIP/Postal Code
92161
Country
United States
Facility Name
UCSF
City
San Francisco
State/Province
California
ZIP/Postal Code
94107
Country
United States
Facility Name
Tower Saint John's Imaging
City
Santa Monica
State/Province
California
ZIP/Postal Code
90403
Country
United States
Facility Name
Yale New Haven Hospital
City
New Haven
State/Province
Connecticut
ZIP/Postal Code
06510
Country
United States
Facility Name
Cardiology Physicians PA/Red Clay Research LLC
City
Newark
State/Province
Delaware
ZIP/Postal Code
19713
Country
United States
Facility Name
University of Florida
City
Gainesville
State/Province
Florida
ZIP/Postal Code
32610
Country
United States
Facility Name
Indago Research and Health Center
City
Hialeah
State/Province
Florida
ZIP/Postal Code
33012
Country
United States
Facility Name
Optimus U Corp
City
Miami
State/Province
Florida
ZIP/Postal Code
33125
Country
United States
Facility Name
Infinite Clinical Research
City
Miami
State/Province
Florida
ZIP/Postal Code
33133-4214
Country
United States
Facility Name
Allied Biomedical Research Institute
City
Miami
State/Province
Florida
ZIP/Postal Code
33155
Country
United States
Facility Name
Comprehensive Vascular Care PA
City
Miami
State/Province
Florida
ZIP/Postal Code
33155
Country
United States
Facility Name
Amavita Clinical Research, LLC
City
North Miami Beach
State/Province
Florida
ZIP/Postal Code
33169
Country
United States
Facility Name
Emory University
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30322
Country
United States
Facility Name
University Of Iowa Hospitals And Clinics
City
Iowa City
State/Province
Iowa
ZIP/Postal Code
52242
Country
United States
Facility Name
Midwest Heart and Vascular Specialists
City
Overland Park
State/Province
Kansas
ZIP/Postal Code
66211
Country
United States
Facility Name
Ochsner Clinic Foundation
City
New Orleans
State/Province
Louisiana
ZIP/Postal Code
70121
Country
United States
Facility Name
Saint Luke's Hospital of Kansas City
City
Kansas City
State/Province
Missouri
ZIP/Postal Code
64111
Country
United States
Facility Name
VA St. Louis Health Care System
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63106
Country
United States
Facility Name
St Louis University
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States
Facility Name
Washington University School of Medicine
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States
Facility Name
Columbia University Medical Center/New York Presbyterian Hospital - Milstein Hospital Building
City
New York
State/Province
New York
ZIP/Postal Code
10032
Country
United States
Facility Name
University of Cincinnati Medical Center
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45219
Country
United States
Facility Name
OhioHealth Research Institute
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43214
Country
United States
Facility Name
University of Pennsylvania
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States
Facility Name
Berks Cardiologists, LTD
City
Wyomissing
State/Province
Pennsylvania
ZIP/Postal Code
19610
Country
United States
Facility Name
University of Tennessee Medical Center
City
Knoxville
State/Province
Tennessee
ZIP/Postal Code
37920
Country
United States
Facility Name
VA North Texas Health Care System - NAVREF - PPDS
City
Dallas
State/Province
Texas
ZIP/Postal Code
75216
Country
United States
Facility Name
University of Texas Southwestern Medical Center
City
Dallas
State/Province
Texas
ZIP/Postal Code
75390
Country
United States
Facility Name
The Methodist Hospital Research Institute
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
Vital Heart & Vein
City
Humble
State/Province
Texas
ZIP/Postal Code
77338
Country
United States
Facility Name
Memorial City and Katy Cardiology Associates
City
Katy
State/Province
Texas
ZIP/Postal Code
77493
Country
United States
Facility Name
University of Virginia Health System
City
Charlottesville
State/Province
Virginia
ZIP/Postal Code
22908
Country
United States
Facility Name
Roanoke Heart Institute
City
Roanoke
State/Province
Virginia
ZIP/Postal Code
24014
Country
United States
Facility Name
University of Ottawa Heart Institute
City
Ottawa
State/Province
Ontario
ZIP/Postal Code
K1Y 4W7
Country
Canada
Facility Name
Center Hospitalier Universitaire de Sherbrooke CHUS
City
Montreal
State/Province
Quebec
ZIP/Postal Code
J1H 5N4
Country
Canada
Facility Name
Montreal Heart Institute
City
Montréal
State/Province
Quebec
ZIP/Postal Code
H1T 1C8
Country
Canada
Facility Name
Turku University Hospital
City
Turku
ZIP/Postal Code
FI-20520
Country
Finland
Facility Name
Hopital Cote de Nacre
City
Caen
ZIP/Postal Code
14033
Country
France
Facility Name
Groupe Hospitalier Bichat Claude Bernard
City
Paris
ZIP/Postal Code
75018
Country
France
Facility Name
Centre Cardiologique Du Nord
City
Saint-Denis
ZIP/Postal Code
93200
Country
France
Facility Name
Universitätsklinikum der RWTH Aachen
City
Aachen
ZIP/Postal Code
52074
Country
Germany
Facility Name
Universitätsklinikum Essen
City
Essen
ZIP/Postal Code
45147
Country
Germany
Facility Name
VU Medisch Centrum
City
Amsterdam
ZIP/Postal Code
1081 HV
Country
Netherlands
Facility Name
Amphia Ziekenhuis - WCN - PPDS
City
Breda
ZIP/Postal Code
4818 CK
Country
Netherlands
Facility Name
Catharina Hospital
City
Eindhoven
ZIP/Postal Code
5623 EJ
Country
Netherlands
Facility Name
Zuyderland Medisch Centrum-WCN-PPDS
City
Heerlen
ZIP/Postal Code
6419 PC
Country
Netherlands
Facility Name
Leids Universitair Medisch Centrum
City
Leiden
ZIP/Postal Code
2333ZA
Country
Netherlands
Facility Name
Hopitaux Universitaires de Geneve
City
Geneva
ZIP/Postal Code
1205
Country
Switzerland
Facility Name
Universitatsspital Zurich
City
Zürich
ZIP/Postal Code
8091
Country
Switzerland
12. IPD Sharing Statement
Citations:
PubMed Identifier
33521873
Citation
Bourque JM, Hanson CA, Agostini D, Bateman TM, Bax JJ, Beanlands RSB, Berman DS, Garcia EV, Heller GV, Knuuti J, Tamaki N, Udelson JE, Maddahi J. Assessing myocardial perfusion in suspected coronary artery disease: rationale and design of the second phase 3, open-label multi-center study of flurpiridaz (F-18) injection for positron emission tomography (PET) imaging. J Nucl Cardiol. 2021 Jun;28(3):1105-1116. doi: 10.1007/s12350-021-02527-8. Epub 2021 Jan 31.
Results Reference
derived
Learn more about this trial
An International Study to Evaluate Diagnostic Efficacy of Flurpiridaz (18F) Injection PET MPI in the Detection of Coronary Artery Disease (CAD)
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