NCT03354273 - An International Study to Evaluate Diagnostic Efficacy of Flurpiridaz (18F) Injection PET MPI in the Detection of Coronary Artery Disease (CAD) | Biotech Hunter

Enrollment

730

Participants

Timeline

Start Date

June 5, 2018

Primary Completion Date

May 5, 2022

Study Completion Date

May 5, 2022

Conditions

Coronary Artery Disease (CAD)

Interventions

DRUG

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.

DRUG

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.

DRUG

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.

Trial Locations (53)

1205

Hopitaux Universitaires de Geneve, Geneva

8091

Universitatsspital Zurich, Zurich

10032

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

14033

Hopital Cote de Nacre, Caen

19104

University of Pennsylvania, Philadelphia

19610

Berks Cardiologists, LTD, Wyomissing

19713

Cardiology Physicians PA/Red Clay Research LLC, Newark

22908

University of Virginia Health System, Charlottesville

24014

Roanoke Heart Institute, Roanoke

30322

Emory University, Atlanta

32610

University of Florida, Gainesville

33012

Indago Research and Health Center, Hialeah

33125

Optimus U Corp, Miami

33155

Allied Biomedical Research Institute, Miami

Comprehensive Vascular Care PA, Miami

33169

Amavita Clinical Research, LLC, North Miami Beach

35294

Vascular Biology and Hypertension Program, University of Alabama at Birmingham, Birmingham

37920

University of Tennessee Medical Center, Knoxville

43214

OhioHealth Research Institute, Columbus

45147

Universitätsklinikum Essen, Essen

45219

University of Cincinnati Medical Center, Cincinnati

52074

Universitätsklinikum der RWTH Aachen, Aachen

52242

University Of Iowa Hospitals And Clinics, Iowa City

63106

VA St. Louis Health Care System, St Louis

63110

St Louis University, St Louis

Washington University School of Medicine, St Louis

64111

Saint Luke's Hospital of Kansas City, Kansas City

66211

Midwest Heart and Vascular Specialists, Overland Park

70121

Ochsner Clinic Foundation, New Orleans

75018

Groupe Hospitalier Bichat Claude Bernard, Paris

75216

VA North Texas Health Care System - NAVREF - PPDS, Dallas

75390

University of Texas Southwestern Medical Center, Dallas

77030

The Methodist Hospital Research Institute, Houston

77338

Vital Heart & Vein, Humble

77493

Memorial City and Katy Cardiology Associates, Katy

90024

University of California- Los Angeles, Los Angeles

90033

Keck Hospital of USC, Los Angeles

90073

VA Greater Los Angeles Health Care System, Los Angeles

90403

Tower Saint John's Imaging, Santa Monica

92161

VA San Diego Health System, San Diego

93200

Centre Cardiologique Du Nord, Saint-Denis

94107

UCSF, San Francisco

06510

Yale New Haven Hospital, New Haven

33133-4214

Infinite Clinical Research, Miami

K1Y 4W7

University of Ottawa Heart Institute, Ottawa

H1T 1C8

Montreal Heart Institute, Montreal

J1H 5N4

Center Hospitalier Universitaire de Sherbrooke CHUS, Montreal

FI-20520

Turku University Hospital, Turku

1081 HV

VU Medisch Centrum, Amsterdam

4818 CK

Amphia Ziekenhuis - WCN - PPDS, Breda

5623 EJ

Catharina Hospital, Eindhoven

6419 PC

Zuyderland Medisch Centrum-WCN-PPDS, Heerlen

2333ZA

Leids Universitair Medisch Centrum, Leiden