Clinical Trial

Detection of Coronary Artery Disease (CAD)

Study Description

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

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.

Location

Locations Selected Location

Methods

Pharmaceutical medication involved Pharmaceutical medication involved
Recruiting patients only Recruiting patients only

Drug - PET MPI

Flurpiridaz (18F) Injection. All subjects will receive 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 will not exceed a total of 14 mCi (520 MBq) for an individual subject.

Drug - SPECT MPI

SPECT imaging must use 99mTc-based myocardial tracers. SPECT agents utilised for the purposes of this clinical study will be administered as per American Society of Nuclear Cardiology or European Association of Cardiovascular Imaging standards, where applicable. All patients will undergo SPECT MPI.

Drug - Pharmacological stress agents

Pharmacologic stress agents will be restricted to the following 3 agents, as permitted by local marketing authorisations and availability: adenosine, dipyridamole, and regadenoson. Administration will be through an IV line.

Additional Information

Official Study 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

Clinical Trial ID

NCT03354273

ParticipAid ID

QeZJEe