← Back to Search

Water PET MPI for Coronary Heart Disease (RAPID-WATER Trial)

Phase 3
Recruiting
Led By Marcelo DiCarli, MD
Research Sponsored by MedTrace Pharma A/S
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Men must use contraceptive methods until the end of the follow-up period
Women of Child Bearing Potential (WOCBP) must be non-pregnant, non-lactating, and practicing appropriate birth control
Must not have
Subjects scheduled for, or planning to undergo, any interventional cardiac procedures between enrollment and ICA (pathway 1) or enrollment and 15O-H2O PET MPI (pathway 2 and 3)
Participants with a known history of cardiac disease including myocardial infarction, previous coronary revascularization, chronic ischemic cardiomyopathy, primary myocardial disease such as cardiac amyloidosis or hypertrophic cardiomyopathy, known left ventricular dysfunction
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 30 days
Awards & highlights

Summary

This trial will test a new PET imaging method to help diagnose coronary artery disease (CAD) in 182 participants at 10 sites in the US & Europe. The participants will receive two doses of a special imaging agent and have safety follow-ups.

Who is the study for?
Adults referred for coronary artery disease (CAD) testing, who can undergo PET imaging and are not pregnant or breastfeeding. They must agree to use contraception and have had recent non-invasive CAD tests or invasive angiography with minimal findings. Excluded are those with significant heart disease history, severe lung conditions, certain medication usage, or involvement in other drug trials.Check my eligibility
What is being tested?
[O-15]-Water PET Myocardial Perfusion Imaging is being tested on participants with suspected CAD. The study involves two doses of [15-O]-H2O during a single PET scan session under rest and stress conditions induced by adenosine at multiple sites in the US and Europe.See study design
What are the potential side effects?
Potential side effects may include reactions to the radiolabeled water injection such as discomfort at the injection site or allergic reactions. Adenosine might cause chest pain, shortness of breath, headache, flushing, nausea, or heart rhythm changes.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I will use birth control until the study ends.
Select...
I am not pregnant or breastfeeding and am using birth control.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
Select...
I am not planning any heart procedures between joining the study and the tests.
Select...
I have a history of heart disease or issues like a heart attack or weak heart muscle.
Select...
I cannot stop taking sildenafil or dipyridamole for 24 hours before the study drug.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~30 days
This trial's timeline: 3 weeks for screening, Varies for treatment, and 30 days for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Sensitivity and specificity of the [15-O]-H2O PET study using the truth-standard of ICA with FFR/iFR or CCTA.
Secondary outcome measures
Adverse event analyses will include tabulations of the incidence (number and percent of subjects) with at least one TEAEs overall and by MedDRA system organ class (SOC) and preferred term (PT). This will be repeated for serious adverse.
Sensitivity, specificity, and accuracy of [15-O]-H2O PET MPI in participants of special clinical interest (female, BMI≥30, diabetics, multivessel disease).

Trial Design

1Treatment groups
Experimental Treatment
Group I: [O-15]-Water PET Myocardial Perfusion Imaging (MPI)Experimental Treatment1 Intervention
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).

Find a Location

Who is running the clinical trial?

MedTrace Pharma A/SLead Sponsor
Nicholas Borys, MDStudy DirectorMedTrace Pharma A/S
1 Previous Clinical Trials
17 Total Patients Enrolled
Emily Vandenbroucke, PhDStudy ChairMedTrace Pharma A/S
1 Previous Clinical Trials
38 Total Patients Enrolled
1 Trials studying Coronary Artery Disease
38 Patients Enrolled for Coronary Artery Disease

Media Library

[O-15]-Water PET Myocardial Perfusion Imaging (MPI) Clinical Trial Eligibility Overview. Trial Name: NCT05134012 — Phase 3
Coronary Artery Disease Research Study Groups: [O-15]-Water PET Myocardial Perfusion Imaging (MPI)
Coronary Artery Disease Clinical Trial 2023: [O-15]-Water PET Myocardial Perfusion Imaging (MPI) Highlights & Side Effects. Trial Name: NCT05134012 — Phase 3
[O-15]-Water PET Myocardial Perfusion Imaging (MPI) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05134012 — Phase 3
~35 spots leftby Dec 2024
Unbiased ResultsWe believe in providing patients with all the options.
Your Data Stays Your DataWe only share your information with the clinical trials you're trying to access.
Verified Trials OnlyAll of our trials are run by licensed doctors, researchers, and healthcare companies.
Back to top