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NCT05134012

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

StatusCompleted
PhasePhase 3
Primary completion
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Record History

All 21 versions: 19 with changes below, 2 re-verified with no change. See every version on ClinicalTrials.gov ↗

  1. Primary endpoints: details revised at 1 of 1 entry Show 6 more changesShow less
    • Trial completed
    • Enrollment target: estimated 215 to confirmed 232
    • Primary and study completion dates changed from estimate of Oct 2026 to Oct 2, 2026
    • Eligibility criteria expanded, about 24 words
    • Secondary endpoints: details revised at 3 of 3 entries
    • Publications: details revised at 1 of 1 entry
  2. Secondary endpoints: 2 to 3v20
  3. Trial status changed: Recruiting → Active, Not Recruiting
    • Primary completion pushed from Apr 30, 2026 to Oct 2026
    • Study completion moved earlier from Dec 31, 2026 to Oct 2026
    • Study sites: 14 to 13
    v19
  4. Site details revised at 1 of 14 sitesv18
  5. Site details revised at 1 of 14 sitesv17
Show 13 earlier versionsHide 13 earlier versions
  1. Study sites: 13 to 14v16
  2. Study sites: 11 to 13v15
  3. Primary completion date: Dec 31, 2025 to Apr 30, 2026
    • Study completion date: Jun 30, 2026 to Dec 31, 2026
    • Site details revised at 2 of 11 sites
    v14
  4. Primary completion date: Dec 31, 2024 to Dec 31, 2025
    • Study completion date: Jun 30, 2025 to Jun 30, 2026
    • Site details revised at 1 of 11 sites
    v13
  5. Site details revised at 1 of 11 sitesv11
  6. Primary completion date: Jun 30, 2024 to Dec 31, 2024
    • Study completion date: Sep 30, 2024 to Jun 30, 2025
    • Eligibility criteria shortened, about 24 words
    v9
  7. Study sites: 8 to 11v8
  8. Site details revised at 2 of 8 sitesv7
  9. Primary endpoint revised
    • Study sites: 6 to 8
    • Eligibility criteria expanded, about 14 words
    v6
  10. Primary completion date: Apr 30, 2023 to Jun 30, 2024
    • Study sites: 3 to 6
    • Study completion date: May 31, 2023 to Sep 30, 2024
    v5
  11. Study sites: 1 to 3v4
  12. Primary completion date: Jan 31, 2024 to Apr 30, 2023v3 Show 5 more changesShow less
    • Study completion date: Mar 31, 2024 to May 31, 2023
    • Interventions: [O-15]-Water PET Cardiac Perfusion Imaging (Drug) to [O-15]-Water PET Myocardial Perfusion Imaging (MPI) (Drug)
    • Eligibility criteria expanded, about 25 words
    • Secondary endpoints revised (2)
    • Study title expanded, about 1 word
  13. Trial status: Not Yet Recruiting to Recruiting
    • Study sites: 0 to 1
    • Start date changed from estimate of Apr 20, 2022 to May 8, 2022
    v2
  1. Study First Submitted
  • Notable: the plan changed
  • Minor: routine updates

Endpoints

Primary

Sensitivity and specificity of the [15-O]-H2O PET study using the truth-standard of ICA with FFR/iFR or CCTA.
Timeframe: 30 days

Secondary (3)

Sensitivity, specificity, and accuracy of [15-O]-H2O PET MPI in participants of special clinical interest (female, BMI≥30, diabetics, multivessel disease).
Sensitivity and specificity of 15O-H2O PET in subjects where the standard of truth may use site-determined value of FFR/iFR when the raw FFR/iFR data are not available to the core lab.
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.

Arms and interventions

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

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).

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

Sites

13 sites in 6 countries

United States 6, Germany 2, Sweden 2, Canada 1, Denmark 1, Netherlands 1