Clinical trial NCT03354273: 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
Overall status: COMPLETED
Phase: PHASE3
Conditions: 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)
Lead sponsor: GE Healthcare
Sponsor class: INDUSTRY
Collaborators: name: Pharmaceutical Product Development, (PPD) LLC
First posted: 2017-11-27
Enrollment: 730
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

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.


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:

  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.

Primary outcomes:
measure: 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
timeFrame: Up to 60 days
Secondary outcomes:
measure: 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
timeFrame: Up to 60 days
measure: 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
timeFrame: Up to 60 days
measure: 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
timeFrame: Up to 60 days
measure: 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
timeFrame: Up to 60 days
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: Vascular Biology and Hypertension Program, University of Alabama at Birmingham
state: Alabama
city: Los Angeles
country: United States
facility: University of California- Los Angeles
state: California
city: Los Angeles
country: United States
facility: Keck Hospital of USC
state: California
city: Los Angeles
country: United States
facility: VA Greater Los Angeles Health Care System
state: California
city: San Diego
country: United States
facility: VA San Diego Health System
state: California
city: San Francisco
country: United States
facility: UCSF
state: California
city: Santa Monica
country: United States
facility: Tower Saint John's Imaging
state: California
city: New Haven
country: United States
facility: Yale New Haven Hospital
state: Connecticut
city: Newark
country: United States
facility: Cardiology Physicians PA/Red Clay Research LLC
state: Delaware
city: Gainesville
country: United States
facility: University of Florida
state: Florida
city: Hialeah
country: United States
facility: Indago Research and Health Center
state: Florida
city: Miami
country: United States
facility: Optimus U Corp
state: Florida
city: Miami
country: United States
facility: Infinite Clinical Research
state: Florida
city: Miami
country: United States
facility: Allied Biomedical Research Institute
state: Florida
city: Miami
country: United States
facility: Comprehensive Vascular Care PA
state: Florida
city: North Miami Beach
country: United States
facility: Amavita Clinical Research, LLC
state: Florida
city: Atlanta
country: United States
facility: Emory University
state: Georgia
city: Iowa City
country: United States
facility: University Of Iowa Hospitals And Clinics
state: Iowa
city: Overland Park
country: United States
facility: Midwest Heart and Vascular Specialists
state: Kansas
city: New Orleans
country: United States
facility: Ochsner Clinic Foundation
state: Louisiana
city: Kansas City
country: United States
facility: Saint Luke's Hospital of Kansas City
state: Missouri
city: Saint Louis
country: United States
facility: VA St. Louis Health Care System
state: Missouri
city: Saint Louis
country: United States
facility: St Louis University
state: Missouri
city: Saint Louis
country: United States
facility: Washington University School of Medicine
state: Missouri
city: New York
country: United States
facility: Columbia University Medical Center/New York Presbyterian Hospital - Milstein Hospital Building
state: New York
city: Cincinnati
country: United States
facility: University of Cincinnati Medical Center
state: Ohio
city: Columbus
country: United States
facility: OhioHealth Research Institute
state: Ohio
city: Philadelphia
country: United States
facility: University of Pennsylvania
state: Pennsylvania
city: Wyomissing
country: United States
facility: Berks Cardiologists, LTD
state: Pennsylvania
city: Knoxville
country: United States
facility: University of Tennessee Medical Center
state: Tennessee
city: Dallas
country: United States
facility: VA North Texas Health Care System - NAVREF - PPDS
state: Texas
city: Dallas
country: United States
facility: University of Texas Southwestern Medical Center
state: Texas
city: Houston
country: United States
facility: The Methodist Hospital Research Institute
state: Texas
city: Humble
country: United States
facility: Vital Heart & Vein
state: Texas
city: Katy
country: United States
facility: Memorial City and Katy Cardiology Associates
state: Texas
city: Charlottesville
country: United States
facility: University of Virginia Health System
state: Virginia
city: Roanoke
country: United States
facility: Roanoke Heart Institute
state: Virginia
city: Ottawa
country: Canada
facility: University of Ottawa Heart Institute
state: Ontario
city: Montreal
country: Canada
facility: Center Hospitalier Universitaire de Sherbrooke CHUS
state: Quebec
city: Montréal
country: Canada
facility: Montreal Heart Institute
state: Quebec
city: Turku
country: Finland
facility: Turku University Hospital
city: Caen
country: France
facility: Hopital Cote de Nacre
city: Paris
country: France
facility: Groupe Hospitalier Bichat Claude Bernard
city: Saint-Denis
country: France
facility: Centre Cardiologique Du Nord
city: Aachen
country: Germany
facility: Universitätsklinikum der RWTH Aachen
city: Essen
country: Germany
facility: Universitätsklinikum Essen
city: Amsterdam
country: Netherlands
facility: VU Medisch Centrum
city: Breda
country: Netherlands
facility: Amphia Ziekenhuis - WCN - PPDS
city: Eindhoven
country: Netherlands
facility: Catharina Hospital
city: Heerlen
country: Netherlands
facility: Zuyderland Medisch Centrum-WCN-PPDS
city: Leiden
country: Netherlands
facility: Leids Universitair Medisch Centrum
city: Geneva
country: Switzerland
facility: Hopitaux Universitaires de Geneve
city: Zürich
country: Switzerland
facility: Universitatsspital Zurich
Study officials:
affiliation: General Electric Healthcare Life Sciences
name: Francois Tranquart, M.D., Ph.D.
role: STUDY_DIRECTOR
References:
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.