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NCT05134012 · ClinicalTrials.gov registry record · Phase 3
RAdiolabeled Perfusion to Identify Coronary Artery Disease Using WAter To Evaluate Responses of Myocardial FLOW (RAPID-WATER-FLOW)
A Phase 3 study of Coronary Artery Disease, sponsored by MedTrace Pharma A/S.
- Recruiting
- Registry status
- Phase 3
- Development phase
- 215
- Enrollment target
- 14
- Study locations
NCT05134012 is a Phase 3 study of Coronary Artery Disease that is actively recruiting participants, run by MedTrace Pharma A/S. The registered enrollment target is 215 participants, below the 1,286-participant average among 219 other Coronary Artery Disease trials with a reported enrollment target (83% lower). The trial reports 14 study locations across 10 states.
The verdict
NCT05134012, a Phase 3 study of Coronary Artery Disease, is actively recruiting participants, sponsored by MedTrace Pharma A/S.
- RECRUITING
- Registry status
- Phase 3
- Development phase
- 215 participants
- Enrollment target
- 14
- Study locations
Study Summary
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 Studied
Interventions
- DRUG [O-15]-Water PET Myocardial Perfusion Imaging (MPI)
Study Locations (14)
Other
- Aarhus University Hospital - Aarhus
- University Hospital Freiburg, Clinic for Nuclear Medicine - Freiburg im Breisgau
- Department of Cardiology and Angiology -- Hannover Medical School (MHH) - Hanover
- Sahlgrenska University Hospital - Gothenburg
- Norrland University Hospital Heart Center - Umeå
Iowa
- University of Iowa - Iowa City
Michigan
- BAMF Healthcare - Grand Rapids
Minnesota
- Mayo Clinic - Rochester
Missouri
- Washington University - St Louis
Pennsylvania
- University of Pittsburgh Medical Center - Pittsburgh
Texas
- UT Southwestern Medical Center - Dallas
Virginia
- University of Virginia Medical Center - Charlottesville
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 215 participants |
| Start Date | 2022-05-08 |
| Est. Completion | 2026-12-31 |
| Phase | Phase 3 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05134012
The ClinicalTrials.gov registry entry for NCT05134012 describes a study currently listed as recruiting, categorized as Phase 3. The registered enrollment target is 215 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 1,286-participant average among 219 other Coronary Artery Disease trials with a reported enrollment target (83% lower). The listed sponsor is MedTrace Pharma A/S, which has 1 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Coronary Artery Disease appearing as the primary indexed condition, and to 1 intervention - of which [O-15]-Water PET Myocardial Perfusion Imaging (MPI) is the first listed.
NCT05134012 reports 14 study locations spanning 10 distinct geographic areas - top geographies include Other, Iowa, Michigan.
Frequently Asked Questions
What is clinical trial NCT05134012 about?
NCT05134012 is a clinical study titled "RAdiolabeled Perfusion to Identify Coronary Artery Disease Using WAter To Evaluate Responses of Myocardial FLOW (RAPID-WATER-FLOW)". 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...
What is the current status of trial NCT05134012?
This trial is currently recruiting. It is a Phase 3 study. The enrollment target is 215 participants. The study started on 2022-05-08. Estimated completion is 2026-12-31.
What conditions does trial NCT05134012 study?
This clinical trial studies the following conditions: Coronary Artery Disease.
What interventions are being tested in trial NCT05134012?
The interventions under investigation include: [O-15]-Water PET Myocardial Perfusion Imaging (MPI) (DRUG).
Who is sponsoring clinical trial NCT05134012?
This trial is sponsored by MedTrace Pharma A/S, which has 1 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05134012 being conducted?
This trial has 14 study locations across Iowa, Michigan, Minnesota, Missouri, Pennsylvania. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Related
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