An International Study to Evaluate Diagnostic Efficacy of Flurpiridaz (18F) Injection PET MPI in the Detection of Coronary Artery Disease (CAD)
NCT ID: NCT03354273
Last Updated: 2023-07-12
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
730 participants
INTERVENTIONAL
2018-06-05
2022-05-05
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
DIAGNOSTIC
NONE
Study Groups
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1
Flurpiridaz PET MPI (following off-study SPECT MPI)
PET MPI
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.
SPECT MPI
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.
Pharmacological stress agents
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.
Interventions
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PET MPI
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.
SPECT MPI
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.
Pharmacological stress agents
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.
Eligibility Criteria
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Inclusion Criteria
* 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 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.
18 Years
ALL
No
Sponsors
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Pharmaceutical Product Development, (PPD) LLC
INDUSTRY
GE Healthcare
INDUSTRY
Responsible Party
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Principal Investigators
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Francois Tranquart, M.D., Ph.D.
Role: STUDY_DIRECTOR
General Electric Healthcare Life Sciences
Locations
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Vascular Biology and Hypertension Program, University of Alabama at Birmingham
Birmingham, Alabama, United States
University of California- Los Angeles
Los Angeles, California, United States
Keck Hospital of USC
Los Angeles, California, United States
VA Greater Los Angeles Health Care System
Los Angeles, California, United States
VA San Diego Health System
San Diego, California, United States
UCSF
San Francisco, California, United States
Tower Saint John's Imaging
Santa Monica, California, United States
Yale New Haven Hospital
New Haven, Connecticut, United States
Cardiology Physicians PA/Red Clay Research LLC
Newark, Delaware, United States
University of Florida
Gainesville, Florida, United States
Indago Research and Health Center
Hialeah, Florida, United States
Optimus U Corp
Miami, Florida, United States
Infinite Clinical Research
Miami, Florida, United States
Allied Biomedical Research Institute
Miami, Florida, United States
Comprehensive Vascular Care PA
Miami, Florida, United States
Amavita Clinical Research, LLC
North Miami Beach, Florida, United States
Emory University
Atlanta, Georgia, United States
University Of Iowa Hospitals And Clinics
Iowa City, Iowa, United States
Midwest Heart and Vascular Specialists
Overland Park, Kansas, United States
Ochsner Clinic Foundation
New Orleans, Louisiana, United States
Saint Luke's Hospital of Kansas City
Kansas City, Missouri, United States
VA St. Louis Health Care System
St Louis, Missouri, United States
St Louis University
St Louis, Missouri, United States
Washington University School of Medicine
St Louis, Missouri, United States
Columbia University Medical Center/New York Presbyterian Hospital - Milstein Hospital Building
New York, New York, United States
University of Cincinnati Medical Center
Cincinnati, Ohio, United States
OhioHealth Research Institute
Columbus, Ohio, United States
University of Pennsylvania
Philadelphia, Pennsylvania, United States
Berks Cardiologists, LTD
Wyomissing, Pennsylvania, United States
University of Tennessee Medical Center
Knoxville, Tennessee, United States
VA North Texas Health Care System - NAVREF - PPDS
Dallas, Texas, United States
University of Texas Southwestern Medical Center
Dallas, Texas, United States
The Methodist Hospital Research Institute
Houston, Texas, United States
Vital Heart & Vein
Humble, Texas, United States
Memorial City and Katy Cardiology Associates
Katy, Texas, United States
University of Virginia Health System
Charlottesville, Virginia, United States
Roanoke Heart Institute
Roanoke, Virginia, United States
University of Ottawa Heart Institute
Ottawa, Ontario, Canada
Montreal Heart Institute
Montreal, Quebec, Canada
Center Hospitalier Universitaire de Sherbrooke CHUS
Montreal, Quebec, Canada
Turku University Hospital
Turku, , Finland
Hopital Cote de Nacre
Caen, , France
Groupe Hospitalier Bichat Claude Bernard
Paris, , France
Centre Cardiologique Du Nord
Saint-Denis, , France
Universitätsklinikum der RWTH Aachen
Aachen, , Germany
Universitätsklinikum Essen
Essen, , Germany
VU Medisch Centrum
Amsterdam, , Netherlands
Amphia Ziekenhuis - WCN - PPDS
Breda, , Netherlands
Catharina Hospital
Eindhoven, , Netherlands
Zuyderland Medisch Centrum-WCN-PPDS
Heerlen, , Netherlands
Leids Universitair Medisch Centrum
Leiden, , Netherlands
Hopitaux Universitaires de Geneve
Geneva, , Switzerland
Universitatsspital Zurich
Zurich, , Switzerland
Countries
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References
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Maddahi J, Agostini D, Bateman TM, Bax JJ, Beanlands RSB, Berman DS, Dorbala S, Garcia EV, Feldman J, Heller GV, Knuuti JM, Martinez-Clark P, Pelletier-Galarneau M, Shepple B, Tamaki N, Tranquart F, Udelson JE. Flurpiridaz F-18 PET Myocardial Perfusion Imaging in Patients With Suspected Coronary Artery Disease. J Am Coll Cardiol. 2023 Oct 17;82(16):1598-1610. doi: 10.1016/j.jacc.2023.08.016.
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.
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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2017-005011-14
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
GE-265-303
Identifier Type: -
Identifier Source: org_study_id
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