RAdiolabeled Perfusion to Identify Coronary Artery Disease Using WAter to Evaluate Responses of Myocardial FLOW (RAPID-WATER-FLOW)

Last updated: February 4, 2025
Sponsor: MedTrace Pharma A/S
Overall Status: Active - Recruiting

Phase

3

Condition

Coronary Artery Disease

Chest Pain

Heart Disease

Treatment

[O-15]-Water PET Myocardial Perfusion Imaging (MPI)

Clinical Study ID

NCT05134012
MedTrace-002
  • Ages > 18
  • All Genders

Study Summary

This a Phase 3, prospective, open-label, multicenter study of [15-O]-H2O injection for PET imaging of subjects with suspected CAD. Approximately 182 evaluable participants with suspected CAD referred for testing will be included in the study at approximately 10 study sites in the United States and Europe. Approximately 215 participants will be enrolled to account for an estimated 15% drop-out rate. Screening assessments will occur prior to enrollment to confirm eligibility. All participants 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). A safety follow-up phone call will occur 24 ± 8 hrs after completion of the [15-O]-H2O scan.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Male and female participants ≥18 years;

  2. Informed consent form (ICF) read, signed, and dated prior to any study proceduresbeing performed;

  3. Participants who fall into any one of the following categories:

  4. Have been referred for an ICA directly of after non-invasive testing (e.g.,SPECT or PET MPI, stress echo, CCTA, ETT).

  5. Had an ICA with no intervention. However, if any stenosis >40% but ≤70% wasobserved, an FFR or iFR assessment was performed.

  6. 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 completedwithin a 30-day window, with time 0 defined as the date of the first of these threetests.

  7. Women of Child Bearing Potential (WOCBP) must be non-pregnant, and non-lactating.For women of childbearing potential, the results of a urine human chorionicgonadotropin (HCG) pregnancy test (with the result known on the day of drugadministration) must be negative; these participants must be practicing appropriatebirth control from time of the screening visit until the end of the follow-upperiod. For women who are either surgically sterile (have a documented bilateraltubal ligation or oophorectomy and/or hysterectomy) or are post-menopausal (cessation of menses for more than 1 year), enrollment in the study without apregnancy test at screening is allowed.

  8. Male will need to use contraceptive methods until end of the follow-up period.

  9. Participants are able to comply with all study procedures as described in theprotocol.

Exclusion

Exclusion Criteria:

  1. Participants are unable to undergo (even partially) any of the imaging procedures;

  2. Participants with a known history of cardiac disease including:

  3. myocardial infarction, previous coronary revascularization, or chronic ischemiccardiomyopathy

  4. primary myocardial disease such as cardiac amyloidosis or hypertrophiccardiomyopathy

  5. known left ventricular dysfunction

  6. moderate or severe aortic or mitral stenosis or regurgitation

  7. Participants in whom adenosine stress testing is contraindicated, including but notlimited to:

  8. Participants with severe COPD or chronic asthma.

  9. Participants with second- or third-degree atrioventricular block without apacemaker.

  10. Participants with claustrophobia to an extent that would limit their ability toundergo SPECT and PET imaging (patients whose claustrophobia is known to be readilycontrolled with drugs or psychological support may be enrolled).

  11. 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 hoursprior to treatment of study drug.

  12. Participants with significant co-morbidities that would prevent appropriatecompletion of the protocol procedures.

  13. Participants who have participated in another research study using investigationaldrugs 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 beon placebo may be enrolled).

  14. Participants who have previously participated in this study.

  15. Subjects scheduled for, or planning to undergo, any interventional cardiacprocedures between enrollment and ICA (pathway 1) or signing of informed consent and 15O-H2O PET MPI (pathway 2 and 3)

Study Design

Total Participants: 215
Treatment Group(s): 1
Primary Treatment: [O-15]-Water PET Myocardial Perfusion Imaging (MPI)
Phase: 3
Study Start date:
May 08, 2022
Estimated Completion Date:
June 30, 2026

Connect with a study center

  • University of Ottawa Heart Institute

    Ottawa, Ontario
    Canada

    Site Not Available

  • Aarhus University Hospital

    Aarhus N,
    Denmark

    Active - Recruiting

  • Sahlgrenska University Hospital

    Gothenburg,
    Sweden

    Active - Recruiting

  • Norrland University Hospital Heart Center

    Umeå,
    Sweden

    Site Not Available

  • University of Iowa

    Iowa City, Iowa 52242
    United States

    Active - Recruiting

  • BAMF Healthcare

    Grand Rapids, Michigan 49503
    United States

    Active - Recruiting

  • Mayo Clinic

    Rochester, Minnesota 55905
    United States

    Active - Recruiting

  • Washington University

    Saint Louis, Missouri 63110
    United States

    Active - Recruiting

  • University of Pittsburgh Medical Center

    Pittsburgh, Pennsylvania 15213
    United States

    Active - Recruiting

  • UT Southwestern Medical Center

    Dallas, Texas 75390
    United States

    Active - Recruiting

  • University of Virginia Medical Center

    Charlottesville, Virginia 22903
    United States

    Active - Recruiting

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