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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 30 days
Awards & highlights
RAPID-WATER 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.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.
RAPID-WATER Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I will use birth control until the study ends.
Select...
I am not pregnant or breastfeeding and am using birth control.
RAPID-WATER Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 30 days
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~30 days
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).
RAPID-WATER 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).
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Who is running the clinical trial?
MedTrace Pharma A/SLead Sponsor
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
Emily VandenbrouckeStudy ChairMedTrace Pharma A/S
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Eligibility Criteria:
This trial includes the following eligibility criteria:- I had a heart scan that showed either no issues or very minor artery problems.You are not able to have any of the required imaging tests.I will use birth control until the study ends.I am not pregnant or breastfeeding and am using birth control.I have a history of heart disease or issues like a heart attack or weak heart muscle.I am 18 years old or older.I completed specific heart tests within the last 30 days.I am not planning any heart procedures between joining the study and the tests.You have severe COPD or chronic asthma, heart block without a pacemaker, or severe claustrophobia that would make it hard for you to have certain medical tests.I cannot stop taking sildenafil or dipyridamole for 24 hours before the study drug.I am referred for an invasive heart artery check after a non-invasive heart test.
Research Study Groups:
This trial has the following groups:- Group 1: [O-15]-Water PET Myocardial Perfusion Imaging (MPI)
Awards:
This trial has 2 awards, including:- 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.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
How many volunteers are being recruited for this research?
"Affirmative. The clinical trial's page on clinicaltrials.gov reveals that it is presently looking for participants, after first being posted in May 8th 2022 and last edited on March 14th 2023. This study needs to enroll 215 individuals across 3 different medical sites."
Answered by AI
Are there any vacancies left in this clinical research project?
"Affirmative. According to clinicaltrials.gov, this medical study is presently enrolling participants and was initially posted on May 8th 2022. It has been updated as recently as March 14th 2023 and requires 215 patients across 3 sites for completion."
Answered by AI
Has the [O-15]-Water PET Myocardial Perfusion Imaging (MPI) been given clearance by the FDA?
"Our Power team gave [O-15]-Water PET Myocardial Perfusion Imaging (MPI) a safety rating of 3, as the existing evidence from Phase 3 clinical trials indicate it is both efficacious and safe."
Answered by AI
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