Recruiting

[15-O]-H2O PET Imaging for Coronary Artery Disease Diagnosis

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Study Aim

The study aims to evaluate the accuracy of [15-O]-H2O PET scans in diagnosing coronary artery disease by comparing them to standard imaging methods in adults.

What is being tested

[O-15]-Water PET Myocardial Perfusion Imaging (MPI)

Drug
Who is being recruted

Arterial Occlusive Diseases+5

+ Arteriosclerosis

+ Cardiovascular Diseases

Over 18 Years
+15 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Diagnostic Study

Phase 3
Interventional
Study Start: May 2022
See protocol details

Summary

Principal SponsorMedTrace Pharma A/S
Study ContactSandra Miran (Europe)More contacts
Last updated: February 6, 2026
Sourced from a government-validated database.Claim as a partner

Study start date: May 8, 2022

Actual date on which the first participant was enrolled.

This clinical trial is designed to evaluate a new method for diagnosing coronary artery disease (CAD), a condition where the blood vessels that supply the heart with blood become narrowed or blocked. The study focuses on using a special imaging technique called PET imaging, which involves the injection of a substance known as \[15-O\]-H2O. This method is being tested on patients who are suspected to have CAD. The goal is to see if this new imaging technique can accurately identify CAD during both resting and stress conditions. Success in this study could lead to a more effective way to diagnose CAD, potentially improving treatment options and outcomes for patients. Participants in this study will receive two injections of \[15-O\]-H2O during a single imaging session. One injection occurs while the participant is at rest, and the other is given while the participant is under stress induced by a medication called adenosine. The study will measure how accurately the PET imaging results, using \[15-O\]-H2O, identify CAD compared to standard diagnostic methods. After the imaging session, a follow-up phone call will be made to ensure participant safety. This study will help determine the sensitivity and specificity of the new method, which refers to its ability to correctly identify those with and without the disease.

Official TitleA 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)
NCT05134012
Principal SponsorMedTrace Pharma A/S
Study ContactSandra Miran (Europe)More contacts
Last updated: February 6, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

215 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Diagnostic Study

Diagnostic studies focus on improving how we detect or confirm a disease. They test new tools or techniques that could provide faster or more accurate diagnoses.



Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

Over 18 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Arterial Occlusive DiseasesArteriosclerosisCardiovascular DiseasesCoronary Artery DiseaseCoronary DiseaseHeart DiseasesVascular DiseasesMyocardial Ischemia

Criteria

6 inclusion criteria required to participate
Participants are able to comply with all study procedures as described in the protocol.

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.

Male will need to use contraceptive methods until end of the follow-up period.

Male and female participants ≥18 years

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9 exclusion criteria prevent from participating
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.

Participants with significant co-morbidities that would prevent appropriate completion of the protocol procedures.

Participants with a known history of cardiac disease including: myocardial infarction, previous coronary revascularization, or chronic ischemic cardiomyopathy; primary myocardial disease such as cardiac amyloidosis or hypertrophic cardiomyopathy; known left ventricular dysfunction; moderate or severe aortic or mitral stenosis or regurgitation

Participants who have previously participated in this study.

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Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

One single intervention group is designated in this study

This study does not include a placebo group 

Treatment Groups

Group I

Experimental
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).

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 14 locations

Recruiting

University of Iowa

Iowa City, United StatesOpen University of Iowa in Google Maps
Recruiting

Mayo Clinic

Rochester, United States
Recruiting

Washington University

St Louis, United States
Recruiting

University of Pittsburgh Medical Center

Pittsburgh, United States
Recruiting
14 Study Centers