Trials / Completed
CompletedNCT03354273
An International Study to Evaluate Diagnostic Efficacy of Flurpiridaz (18F) Injection PET MPI in the Detection of Coronary Artery Disease (CAD)
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
- Status
- Completed
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 730 (actual)
- Sponsor
- GE Healthcare · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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
Interventions
| Type | Name | Description |
|---|---|---|
| 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. |
Timeline
- Start date
- 2018-06-05
- Primary completion
- 2022-05-05
- Completion
- 2022-05-05
- First posted
- 2017-11-27
- Last updated
- 2023-07-12
- Results posted
- 2023-07-12
Locations
53 sites across 7 countries: United States, Canada, Finland, France, Germany, Netherlands, Switzerland
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT03354273. Inclusion in this directory is not an endorsement.