RAdiolabeled Perfusion to Identify Coronary Artery Disease Using WAter To Evaluate Responses of Myocardial FLOW (RAPID-WATER-FLOW)
NCT ID: NCT05134012
Last Updated: 2025-12-17
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE3
215 participants
INTERVENTIONAL
2022-05-08
2026-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
DIAGNOSTIC
NONE
Study Groups
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[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).
[O-15]-Water PET Myocardial Perfusion Imaging (MPI)
\[15-O\]-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.
Interventions
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[O-15]-Water PET Myocardial Perfusion Imaging (MPI)
\[15-O\]-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.
Eligibility Criteria
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Inclusion Criteria
2. Informed consent form (ICF) read, signed, and dated prior to any study procedures being performed;
3. Participants who fall into any one of the following categories:
1. Have been referred for an ICA directly of after non-invasive testing (e.g., SPECT or PET MPI, stress echo, CCTA, ETT).
2. Had an ICA with no intervention. However, if any stenosis \>40% but ≤70% was observed, an FFR or iFR assessment was performed.
3. 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.
4. 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.
5. Male will need to use contraceptive methods until end of the follow-up period.
6. Participants are able to comply with all study procedures as described in the protocol.
Exclusion Criteria
2. Participants with a known history of cardiac disease including:
1. myocardial infarction, previous coronary revascularization, or chronic ischemic cardiomyopathy
2. primary myocardial disease such as cardiac amyloidosis or hypertrophic cardiomyopathy
3. known left ventricular dysfunction
4. moderate or severe aortic or mitral stenosis or regurgitation
3. Participants in whom adenosine stress testing is contraindicated, including but not limited to:
1. Participants with severe COPD or chronic asthma.
2. Participants with second- or third-degree atrioventricular block without a pacemaker.
4. 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).
5. 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.
6. Participants with significant co-morbidities that would prevent appropriate completion of the protocol procedures.
7. 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).
8. Participants who have previously participated in this study.
9. 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)
18 Years
ALL
No
Sponsors
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MedTrace Pharma A/S
INDUSTRY
Responsible Party
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Principal Investigators
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Nicholas Borys, MD
Role: STUDY_DIRECTOR
MedTrace Pharma A/S
Marcelo DiCarli, MD
Role: PRINCIPAL_INVESTIGATOR
Brigham and Women's Hospital
Locations
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University of Iowa
Iowa City, Iowa, United States
BAMF Healthcare
Grand Rapids, Michigan, United States
Mayo Clinic
Rochester, Minnesota, United States
Washington University
St Louis, Missouri, United States
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, United States
UT Southwestern Medical Center
Dallas, Texas, United States
University of Virginia Medical Center
Charlottesville, Virginia, United States
University of Ottawa Heart Institute
Ottawa, Ontario, Canada
Aarhus University Hospital
Aarhus, , Denmark
University Hospital Freiburg, Clinic for Nuclear Medicine
Freiburg im Breisgau, , Germany
Department of Cardiology and Angiology -- Hannover Medical School (MHH)
Hanover, , Germany
Amsterdam University Medical Center, Department of Radiology and Nuclear Medicine
Amsterdam, North Holland, Netherlands
Sahlgrenska University Hospital
Gothenburg, , Sweden
Norrland University Hospital Heart Center
Umeå, , Sweden
Countries
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Central Contacts
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Facility Contacts
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Parren S McNeely, MD
Role: primary
Geoffrey B Johnson, MD
Role: primary
Thomas Schindler, MD
Role: primary
Prem Soman, MD
Role: primary
Orhan Oz, MD
Role: primary
Jamieson Bourque, MD
Role: primary
Kevin Boczar, MD
Role: primary
Professor, Department of Nuclear Medicine & PET-Centre
Role: primary
Christian Goetz, MD
Role: primary
Johann Bauersachs, MD
Role: primary
Christian Polte, MD
Role: primary
Fredrik Valham, MD
Role: primary
References
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Di Carli MF, Gormsen LC, Chareonthaitawee P, Johnson GB, Beanlands R, DeKemp R, Schindler T, Gropler R, Kulkarni H, McNeely P, Soman P, Oz O, Zaha V, Sorensen J, Harms H, Orlandi C, Vandenbroucke E, Udelson J. Rationale and design of the RAPID-WATER-FLOW trial: Radiolabeled perfusion to identify coronary artery disease using water to evaluate responses of myocardial FLOW. J Nucl Cardiol. 2024 Jan;31:101779. doi: 10.1016/j.nuclcard.2023.101779. Epub 2023 Dec 5.
Other Identifiers
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MedTrace-002
Identifier Type: -
Identifier Source: org_study_id