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

NCT03354273 | Completed Phase 3 Results DMC FDA Drug

• 2 other identifiers: GE-265-3032017-005011-14
• Study Type: interventional
• Target: 730
• Locations: 7 countries
• Sites: 53

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.

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)

Outcome Measures

Primary Outcomes (1)

• 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.

  Up to 60 days

Secondary Outcomes (4)

• 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 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 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 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

Study Arms (1)

1

EXPERIMENTAL

Flurpiridaz PET MPI (following off-study SPECT MPI)

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

Interventions

PET MPI DRUG

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.

1

SPECT MPI DRUG

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.

1

Pharmacological stress agents DRUG

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.

1

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• GE Healthcare: lead
• Pharmaceutical Product Development, (PPD) LLC: collaborator

Study Sites (53)

Vascular Biology and Hypertension Program, University of Alabama at Birmingham

Birmingham, Alabama, 35294, United States

Location

University of California- Los Angeles

Los Angeles, California, 90024, United States

Location

Keck Hospital of USC

Los Angeles, California, 90033, United States

Location

VA Greater Los Angeles Health Care System

Los Angeles, California, 90073, United States

Location

VA San Diego Health System

San Diego, California, 92161, United States

Location

UCSF

San Francisco, California, 94107, United States

Location

Tower Saint John's Imaging

Santa Monica, California, 90403, United States

Location

Yale New Haven Hospital

New Haven, Connecticut, 06510, United States

Location

Cardiology Physicians PA/Red Clay Research LLC

Newark, Delaware, 19713, United States

Location

University of Florida

Gainesville, Florida, 32610, United States

Location

Indago Research and Health Center

Hialeah, Florida, 33012, United States

Location

Optimus U Corp

Miami, Florida, 33125, United States

Location

Infinite Clinical Research

Miami, Florida, 33133-4214, United States

Location

Allied Biomedical Research Institute

Miami, Florida, 33155, United States

Location

Comprehensive Vascular Care PA

Miami, Florida, 33155, United States

Location

Amavita Clinical Research, LLC

North Miami Beach, Florida, 33169, United States

Location

Emory University

Atlanta, Georgia, 30322, United States

Location

University Of Iowa Hospitals And Clinics

Iowa City, Iowa, 52242, United States

Location

Midwest Heart and Vascular Specialists

Overland Park, Kansas, 66211, United States

Location

Ochsner Clinic Foundation

New Orleans, Louisiana, 70121, United States

Location

Saint Luke's Hospital of Kansas City

Kansas City, Missouri, 64111, United States

Location

VA St. Louis Health Care System

St Louis, Missouri, 63106, United States

Location

St Louis University

St Louis, Missouri, 63110, United States

Location

Washington University School of Medicine

St Louis, Missouri, 63110, United States

Location

Columbia University Medical Center/New York Presbyterian Hospital - Milstein Hospital Building

New York, New York, 10032, United States

Location

University of Cincinnati Medical Center

Cincinnati, Ohio, 45219, United States

Location

OhioHealth Research Institute

Columbus, Ohio, 43214, United States

Location

University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Location

Berks Cardiologists, LTD

Wyomissing, Pennsylvania, 19610, United States

Location

University of Tennessee Medical Center

Knoxville, Tennessee, 37920, United States

Location

VA North Texas Health Care System - NAVREF - PPDS

Dallas, Texas, 75216, United States

Location

University of Texas Southwestern Medical Center

Dallas, Texas, 75390, United States

Location

The Methodist Hospital Research Institute

Houston, Texas, 77030, United States

Location

Vital Heart & Vein

Humble, Texas, 77338, United States

Location

Memorial City and Katy Cardiology Associates

Katy, Texas, 77493, United States

Location

University of Virginia Health System

Charlottesville, Virginia, 22908, United States

Location

Roanoke Heart Institute

Roanoke, Virginia, 24014, United States

Location

University of Ottawa Heart Institute

Ottawa, Ontario, K1Y 4W7, Canada

Location

Montreal Heart Institute

Montreal, Quebec, H1T 1C8, Canada

Location

Center Hospitalier Universitaire de Sherbrooke CHUS

Montreal, Quebec, J1H 5N4, Canada

Location

Turku University Hospital

Turku, FI-20520, Finland

Location

Hopital Cote de Nacre

Caen, 14033, France

Location

Groupe Hospitalier Bichat Claude Bernard

Paris, 75018, France

Location

Centre Cardiologique Du Nord

Saint-Denis, 93200, France

Location

Universitätsklinikum der RWTH Aachen

Aachen, 52074, Germany

Location

Universitätsklinikum Essen

Essen, 45147, Germany

Location

VU Medisch Centrum

Amsterdam, 1081 HV, Netherlands

Location

Amphia Ziekenhuis - WCN - PPDS

Breda, 4818 CK, Netherlands

Location

Catharina Hospital

Eindhoven, 5623 EJ, Netherlands

Location

Zuyderland Medisch Centrum-WCN-PPDS

Heerlen, 6419 PC, Netherlands

Location

Leids Universitair Medisch Centrum

Leiden, 2333ZA, Netherlands

Location

Hopitaux Universitaires de Geneve

Geneva, 1205, Switzerland

Location

Universitatsspital Zurich

Zurich, 8091, Switzerland

Location

Related Publications (2)

• 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.

  PMID: 37821170 DERIVED

• 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.

  PMID: 33521873 DERIVED

MeSH Terms

Conditions

Coronary Artery Disease

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases

Results Point of Contact

• Title: Francois Tranquart, M.D., Ph.D
• Organization: GE HealthCare

francois.tranquart@ge.com

447775543206

Study Officials

• Francois Tranquart, M.D., Ph.D.

  General Electric Healthcare Life Sciences

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 21, 2017
• First Posted: November 27, 2017
• Study Start: June 5, 2018
• Primary Completion: May 5, 2022
• Study Completion: May 5, 2022
• Last Updated: July 12, 2023
• Results First Posted: July 12, 2023

Record last verified: 2023-06

Locations

CA (3); FR (3); DE (2); US (37); CH (2); FI (1); NL (5)