- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05134012
RAdiolabeled Perfusion to Identify Coronary Artery Disease Using WAter To Evaluate Responses of Myocardial FLOW (RAPID-WATER-FLOW)
A 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)
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Estimated)
Phase
- Phase 3
Contacts and Locations
Study Contact
- Name: Taylor A Williams
- Phone Number: 162 16178024048
- Email: twilliams@ccstrials.com
Study Contact Backup
- Name: Michael DiBattista
- Email: mdibattista@ccstrials.com
Study Locations
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Ontario
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Ottawa, Ontario, Canada
- Not yet recruiting
- University of Ottawa Heart Institute
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Contact:
- Kevin Boczar, MD
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Aarhus N, Denmark
- Recruiting
- Aarhus University Hospital
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Contact:
- Professor, Department of Nuclear Medicine & PET-Centre
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Gothenburg, Sweden
- Not yet recruiting
- Sahlgrenska University Hospital
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Contact:
- Christian Polte, MD
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Umeå, Sweden
- Not yet recruiting
- Norrland University Hospital Heart Center
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Contact:
- Fredrik Valham, MD
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Iowa
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Iowa City, Iowa, United States, 52242
- Recruiting
- University of Iowa
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Contact:
- Parren S McNeely, MD
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Michigan
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Grand Rapids, Michigan, United States, 49503
- Recruiting
- BAMF Healthcare
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Contact:
- Jeremiah Johns, MD
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Minnesota
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Rochester, Minnesota, United States, 55905
- Recruiting
- Mayo Clinic
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Contact:
- Geoffrey B Johnson, MD
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Missouri
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Saint Louis, Missouri, United States, 63110
- Recruiting
- Washington University
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Contact:
- Thomas Schindler, MD
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Pennsylvania
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Pittsburgh, Pennsylvania, United States, 15213
- Recruiting
- University of Pittsburgh Medical Center
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Contact:
- Prem Soman, MD
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Texas
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Dallas, Texas, United States, 75390
- Recruiting
- UT Southwestern Medical Center
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Contact:
- Orhan Oz, MD
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Virginia
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Charlottesville, Virginia, United States, 22903
- Not yet recruiting
- University of Virginia Medical Center
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Contact:
- Jamieson Bourque, MD
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Male and female participants ≥18 years;
- Informed consent form (ICF) read, signed, and dated prior to any study procedures being performed;
Participants who fall into any one of the following categories:
- Have been referred for an ICA directly of after non-invasive testing (e.g., SPECT or PET MPI, stress echo, CCTA, ETT).
- Had an ICA with no intervention. However, if any stenosis >40% but ≤70% was observed, an FFR or iFR assessment was performed.
- Had a CCTA with normal coronaries or minimal CAD (no stenosis >25%).
The SPECT study, PET 15O-H2O study, and ICA or CCTA testing need to be completed within a 30-day window, with time 0 defined as the date of the first of these three tests.
- 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.
- Participants are able to comply with all study procedures as described in the protocol.
Exclusion Criteria:
- Participants are unable to undergo (even partially) any of the imaging 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 in whom adenosine stress testing is contraindicated, including but not limited to:
- Participants with severe COPD or chronic asthma.
- Participants with second- or third-degree atrioventricular block without a pacemaker.
- Participants with claustrophobia to an extent that would limit their ability to undergo SPECT and PET imaging (patients whose claustrophobia is known to be readily controlled with drugs or psychological support may be enrolled).
- 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 who have participated in another research study using investigational drugs within the 30 days prior to enrollment or through the duration of the trial (patients in observational studies with approved agents and participants known to be on placebo may be enrolled).
- Participants who have previously participated in this study.
- Subjects scheduled for, or planning to undergo, any interventional cardiac procedures between enrollment and ICA (pathway 1) or signing of informed consent and 15O-H2O PET MPI (pathway 2 and 3)
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Diagnostic
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
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).
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[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.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
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Sensitivity and specificity are defined as follows:
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30 days
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Sensitivity, specificity, and accuracy of [15-O]-H2O PET MPI in participants of special clinical interest (female, BMI≥30, diabetics, multivessel disease).
Time Frame: 30 days
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Sensitivity and specificity are defined as follows:
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30 days
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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.
Time Frame: 30 days
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Other Safety measures including the following will be summarized descriptively:
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30 days
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Collaborators and Investigators
Sponsor
Investigators
- Study Director: Emily Vandenbroucke, PhD, MedTrace Pharma A/S
- Principal Investigator: Marcelo DiCarli, MD, Brigham and Women's Hospital
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- MedTrace-002
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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University of EdinburghBritish Heart Foundation; National Institute for Public Health and the Environment...Unknown
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