RAdiolabeled Perfusion to Identify Coronary Artery Disease Using WAter To Evaluate Responses of Myocardial FLOW (RAPID-WATER-FLOW) (NCT05134012)
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)
🩺 Plain-English Summary (8th-Grade Level)
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.
Who can join: Review the eligibility criteria below.
Location: University of Iowa — Iowa City, Iowa
Age range: 18 Years
🧪 Interventions in This Study
📋 "Do I Qualify?" — 1-Minute Self Screener
Instant ChecklistFull eligibility criteria are available on the official NIH protocol. View the criteria ↗
📍 All Participating Trial Locations (13 Sites)
- University of Iowa — Iowa City, Iowa
- Mayo Clinic — Rochester, Minnesota
- Washington University — St Louis, Missouri
- University of Pittsburgh Medical Center — Pittsburgh, Pennsylvania
- UT Southwestern Medical Center — Dallas, Texas
- University of Virginia Medical Center — Charlottesville, Virginia
- University of Ottawa Heart Institute — Ottawa, Ontario
- Aarhus University Hospital — Aarhus,
- University Hospital Freiburg, Clinic for Nuclear Medicine — Freiburg im Breisgau,
- Department of Cardiology and Angiology -- Hannover Medical School (MHH) — Hanover,
- Amsterdam University Medical Center, Department of Radiology and Nuclear Medicine — Amsterdam, North Holland
- Sahlgrenska University Hospital — Gothenburg,
- Norrland University Hospital Heart Center — Umeå,
💰 Cost, Insurance & Patient Rights
- 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
- Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
- Voluntary Participation: You may withdraw at any time without affecting your standard medical care.
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💡 How to Participate
- Check the checklist above to see if you may qualify.
- Review the official NIH record below to find the coordinating site.
- Ask about the visit schedule, what is covered at no cost, and any travel support.
- Confirm with your own doctor before making a decision.