Using water to improve imaging for coronary artery disease

A Phase 3, Multicenter, Open Label Study to Confirm the Diagnostic Potential of Intravenously Administered [15-O]-H2O to Identify Coronary Artery Disease During Pharmacological Stress and Resting Conditions Using PET Imaging (RAPID-WATER-FLOW)

This study is testing if a special type of water can help doctors get better images of the heart to find out if people have coronary artery disease.

Quick facts

• Phase: Phase 3
• Study type: Interventional
• Enrollment: 215 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: MedTrace Pharma A/S (Industry-sponsored)
• Locations: 14 sites (Iowa City, Iowa and 13 other locations)
• Trial ID: NCT05134012 on ClinicalTrials.gov

What this trial studies

This Phase 3 interventional study evaluates the use of oxygen-15 labeled water for PET imaging in patients suspected of having coronary artery disease (CAD). Approximately 215 participants will be enrolled across 10 sites in the U.S. and Europe, with each participant receiving two doses of the tracer during a single imaging session—one at rest and one during pharmacological stress. The study aims to assess myocardial blood flow and perfusion to better identify CAD. A follow-up safety call will occur 24 hours after the imaging session.

Who should consider this trial

Good fit: Ideal candidates include adults over 18 years who have been referred for coronary artery evaluation due to suspected CAD.

Not a fit: Patients with significant coronary artery stenosis requiring immediate intervention or those with contraindications to PET imaging may not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could lead to more accurate diagnosis and management of coronary artery disease.

How similar studies have performed: Previous studies using similar PET imaging techniques have shown promise in improving the diagnosis of coronary artery disease.

Eligibility criteria

Inclusion Criteria:

1. Male and female participants ≥18 years;
2. Informed consent form (ICF) read, signed, and dated prior to any study procedures being performed;
3. Participants who fall into any one of the following categories:

   1. Have been referred for an ICA directly of after non-invasive testing (e.g., SPECT or PET MPI, stress echo, CCTA, ETT).
   2. Had an ICA with no intervention. However, if any stenosis \>40% but ≤70% was observed, an FFR or iFR assessment was performed.
   3. Had a CCTA with normal coronaries or minimal CAD (no stenosis \>25%).

   The SPECT study, PET 15O-H2O study, and ICA or CCTA testing need to be completed within a 30-day window, with time 0 defined as the date of the first of these three tests.
4. Women of Child Bearing Potential (WOCBP) must be non-pregnant, and non-lactating. For women of childbearing potential, the results of a urine human chorionic gonadotropin (HCG) pregnancy test (with the result known on the day of drug administration) must be negative; these participants must be practicing appropriate birth control from time of the screening visit until the end of the follow-up period. For women who are either surgically sterile (have a documented bilateral tubal ligation or oophorectomy and/or hysterectomy) or are post-menopausal (cessation of menses for more than 1 year), enrollment in the study without a pregnancy test at screening is allowed.
5. Male will need to use contraceptive methods until end of the follow-up period.
6. Participants are able to comply with all study procedures as described in the protocol.

Exclusion Criteria:

1. Participants are unable to undergo (even partially) any of the imaging procedures;
2. Participants with a known history of cardiac disease including:

   1. myocardial infarction, previous coronary revascularization, or chronic ischemic cardiomyopathy
   2. primary myocardial disease such as cardiac amyloidosis or hypertrophic cardiomyopathy
   3. known left ventricular dysfunction
   4. moderate or severe aortic or mitral stenosis or regurgitation
3. Participants in whom adenosine stress testing is contraindicated, including but not limited to:

   1. Participants with severe COPD or chronic asthma.
   2. Participants with second- or third-degree atrioventricular block without a pacemaker.
4. Participants with claustrophobia to an extent that would limit their ability to undergo SPECT and PET imaging (patients whose claustrophobia is known to be readily controlled with drugs or psychological support may be enrolled).
5. Participants who are on sildenafil (Viagra) or oral dipyridamole (Persantine, Aggrenox) therapy or on any PDE5 inhibitor (i.e. tadalafil, avanafil, vardenafil),and for whom its use cannot be terminated or suspended for ≥24 hours prior to treatment of study drug.
6. Participants with significant co-morbidities that would prevent appropriate completion of the protocol procedures.
7. Participants who have participated in another research study using investigational drugs within the 30 days prior to enrollment or through the duration of the trial (patients in observational studies with approved agents and participants known to be on placebo may be enrolled).
8. Participants who have previously participated in this study.
9. Subjects scheduled for, or planning to undergo, any interventional cardiac procedures between enrollment and ICA (pathway 1) or signing of informed consent and 15O-H2O PET MPI (pathway 2 and 3)

Where this trial is running

Iowa City, Iowa and 13 other locations

• University of Iowa — Iowa City, Iowa, United States (Recruiting)
• BAMF Healthcare — Grand Rapids, Michigan, United States (Withdrawn)
• Mayo Clinic — Rochester, Minnesota, United States (Recruiting)
• Washington University — St Louis, Missouri, United States (Recruiting)
• University of Pittsburgh Medical Center — Pittsburgh, Pennsylvania, United States (Recruiting)
• UT Southwestern Medical Center — Dallas, Texas, United States (Recruiting)
• University of Virginia Medical Center — Charlottesville, Virginia, United States (Recruiting)
• University of Ottawa Heart Institute — Ottawa, Ontario, Canada (Recruiting)
• Aarhus University Hospital — Aarhus, Denmark (Recruiting)
• University Hospital Freiburg, Clinic for Nuclear Medicine — Freiburg im Breisgau, Germany (Recruiting)
• Department of Cardiology and Angiology -- Hannover Medical School (MHH) — Hanover, Germany (Recruiting)
• Amsterdam University Medical Center, Department of Radiology and Nuclear Medicine — Amsterdam, North Holland, Netherlands (Recruiting)
• Sahlgrenska University Hospital — Gothenburg, Sweden (Recruiting)
• Norrland University Hospital Heart Center — Umeå, Sweden (Recruiting)

Study contacts

• Principal investigator: Marcelo DiCarli, MD — Brigham and Women's Hospital
• Study coordinator: Sandra Miran (Europe)

Conditions Coronary Artery Disease; Myocardial Blood Flow; Myocardial Perfusion Imaging; RAPID-WATER-FLOW; Positron Emission Tomography; Oxygen-15