Actively Recruiting
RAdiolabeled Perfusion to Identify Coronary Artery Disease Using WAter To Evaluate Responses of Myocardial FLOW (RAPID-WATER-FLOW)
Led by MedTrace Pharma A/S · Updated on 2026-02-05
215
Participants Needed
14
Research Sites
242 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This a Phase 3, prospective, open-label, multicenter study of \[15-O\]-H2O injection for PET imaging of subjects with suspected CAD. Approximately 182 evaluable participants with suspected CAD referred for testing will be included in the study at approximately 10 study sites in the United States and Europe. Approximately 215 participants will be enrolled to account for an estimated 15% drop-out rate. Screening assessments will occur prior to enrollment to confirm eligibility. All participants will receive two doses of \[15-O\]-H2O as part of a single PET imaging session (one dose at rest and one during pharmacological stress with adenosine). A safety follow-up phone call will occur 24 ± 8 hrs after completion of the \[15-O\]-H2O scan.
CONDITIONS
Official Title
RAdiolabeled Perfusion to Identify Coronary Artery Disease Using WAter To Evaluate Responses of Myocardial FLOW (RAPID-WATER-FLOW)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Participants aged 18 years or older
- Participants who have given signed informed consent
- Participants referred for invasive coronary angiography directly or after non-invasive testing (e.g., SPECT, PET MPI, stress echo, CCTA, or exercise treadmill test)
- Participants who had invasive coronary angiography with no intervention but had a fractional flow reserve or instantaneous wave-free ratio assessment if stenosis between 40% and 70% was observed
- Participants who had a computed tomography coronary angiogram with normal or minimal coronary artery disease (no stenosis over 25%)
- All coronary testing (SPECT, PET 15O-H2O, and invasive or CT angiography) completed within a 30-day window
- Women of childbearing potential must be non-pregnant, non-lactating, have a negative urine pregnancy test on the day of drug administration, and use appropriate birth control until the end of follow-up
- Women surgically sterile or post-menopausal for over 1 year may enroll without a pregnancy test
- Male participants must use contraception until the end of follow-up
- Participants able to comply with all study procedures
You will not qualify if you...
- Participants unable to undergo all or part of the imaging procedures
- Participants with a history of cardiac disease including myocardial infarction, previous coronary revascularization, chronic ischemic cardiomyopathy, primary myocardial disease like cardiac amyloidosis or hypertrophic cardiomyopathy, left ventricular dysfunction, or moderate to severe aortic or mitral valve stenosis or regurgitation
- Participants for whom adenosine stress testing is contraindicated, including those with severe COPD, chronic asthma, or second- or third-degree atrioventricular block without a pacemaker
- Participants with claustrophobia severe enough to limit imaging participation, unless controlled with drugs or psychological support
- Participants taking sildenafil, dipyridamole, or PDE5 inhibitors who cannot stop these drugs 24 hours before study drug administration
- Participants with significant co-morbidities preventing protocol completion
- Participants who have participated in another investigational drug study within 30 days prior or during this trial
- Participants who have previously participated in this study
- Participants scheduled for or planning interventional cardiac procedures between enrollment and the coronary angiography or PET imaging
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 14 locations
1
University of Iowa
Iowa City, Iowa, United States, 52242
Actively Recruiting
2
BAMF Healthcare
Grand Rapids, Michigan, United States, 49503
Withdrawn
3
Mayo Clinic
Rochester, Minnesota, United States, 55905
Actively Recruiting
4
Washington University
St Louis, Missouri, United States, 63110
Actively Recruiting
5
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, United States, 15213
Actively Recruiting
6
UT Southwestern Medical Center
Dallas, Texas, United States, 75390
Actively Recruiting
7
University of Virginia Medical Center
Charlottesville, Virginia, United States, 22903
Actively Recruiting
8
University of Ottawa Heart Institute
Ottawa, Ontario, Canada
Actively Recruiting
9
Aarhus University Hospital
Aarhus, Denmark
Actively Recruiting
10
University Hospital Freiburg, Clinic for Nuclear Medicine
Freiburg im Breisgau, Germany
Actively Recruiting
11
Department of Cardiology and Angiology -- Hannover Medical School (MHH)
Hanover, Germany
Actively Recruiting
12
Amsterdam University Medical Center, Department of Radiology and Nuclear Medicine
Amsterdam, North Holland, Netherlands, 1081HV
Actively Recruiting
13
Sahlgrenska University Hospital
Gothenburg, Sweden
Actively Recruiting
14
Norrland University Hospital Heart Center
Umeå, Sweden
Actively Recruiting
Research Team
S
Sandra Miran (Europe)
CONTACT
L
Laurel Sindelar (North America)
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
DIAGNOSTIC
Number of Arms
1
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