RAdiolabeled Perfusion to Identify Coronary Artery Disease Using WAter To Evaluate Responses of Myocardial FLOW (RAPID-WATER-FLOW)

Part of paid clinical trials in Iowa City, Iowa.

Sponsor
MedTrace Pharma A/S
Study ID
NCT05134012
Phase
PHASE3
Status
Recruiting
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Conditions

  • Coronary Artery Disease

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • [O-15]-Water PET Myocardial Perfusion Imaging (MPI) — DRUG
    \[15-O\]-H2O injection is a novel PET imaging agent labeled with the radioisotope \[15-O\] administered as an intravenous (IV) injection. Participants will receive \[15-O\]-H2O treatment twice as a part of a single day imaging session. All participants will receive two IV boluses of \[15-O\]-H2O injection in a peripheral vein; one at rest and one during pharmacological stress.

Study Details

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.

Key Dates

Start date
May 8, 2022
Status verified
Feb 2026
Primary completion
Apr 30, 2026
Completion
Dec 31, 2026

Study Design

Enrollment
215 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC

Arms

  • Experimental: [O-15]-Water PET Myocardial Perfusion Imaging (MPI)
    All participants with suspected CAD 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).

Primary Outcome Measure

Sensitivity and specificity of the [15-O]-H2O PET study using the truth-standard of ICA with FFR/iFR or CCTA. [ Time Frame: 30 days ]

Central Contacts

Locations (7)

FacilityCityStateZIPSite coordinators
University of IowaIowa CityIowa52242
Parren S McNeely, MD
BAMF HealthcareGrand RapidsMichigan49503-
Mayo ClinicRochesterMinnesota55905
Geoffrey B Johnson, MD
Washington UniversitySt LouisMissouri63110
Thomas Schindler, MD
University of Pittsburgh Medical CenterPittsburghPennsylvania15213
Prem Soman, MD
UT Southwestern Medical CenterDallasTexas75390
Orhan Oz, MD
University of Virginia Medical CenterCharlottesvilleVirginia22903
Jamieson Bourque, MD

Find similar trials in Iowa City, IA

By research site
University of Iowa· Iowa City, IABAMF Healthcare· Grand Rapids, MIMayo Clinic· Rochester, MNWashington University· St Louis, MOUniversity of Pittsburgh Medical Center· Pittsburgh, PAUT Southwestern Medical Center· Dallas, TX

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