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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

No Placebo-Only Group

Pivotal Trial

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.

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.

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

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I will use birth control until the study ends.

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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:

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I am not planning any heart procedures between joining the study and the tests.

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I have a history of heart disease or issues like a heart attack or weak heart muscle.

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I cannot stop taking sildenafil or dipyridamole for 24 hours before the study drug.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 30 days

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

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

Secondary study objectives

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).

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

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).

0 / 5Eligibility criteria met