RAdiolabeled Perfusion to Identify Coronary Artery Disease Using WAter To Evaluate Responses of Myocardial FLOW (RAPID-WATER-FLOW)
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ClinicalTrials.gov Identifier: NCT05134012 |
Recruitment Status :
Recruiting
First Posted : November 24, 2021
Last Update Posted : April 18, 2024
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Sponsor:
MedTrace Pharma A/S
Information provided by (Responsible Party):
MedTrace Pharma A/S
Tracking Information | |||||||||
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First Submitted Date ICMJE | October 29, 2021 | ||||||||
First Posted Date ICMJE | November 24, 2021 | ||||||||
Last Update Posted Date | April 18, 2024 | ||||||||
Actual Study Start Date ICMJE | May 8, 2022 | ||||||||
Estimated Primary Completion Date | December 31, 2024 (Final data collection date for primary outcome measure) | ||||||||
Current Primary Outcome Measures ICMJE |
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 ] Sensitivity and specificity are defined as follows:
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Original Primary Outcome Measures ICMJE |
Sensitivity and specificity of the [15-O]-H2O PET study using the truth-standard of ICA with FFR or CCTA. [ Time Frame: 30 days ] All efficacy assessments will be based on a blinded analysis of all imaging data. The primary efficacy endpoints of the study are the sensitivity and specificity defined as follows:
Sensitivity = Number of participants with true-positive [15-O]-H2O assessments / Number of participants with CAD
Specificity = Number of participants with true-negative [15-O]-H2O assessments / Number of participants with no CAD
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Change History | |||||||||
Current Secondary Outcome Measures ICMJE |
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Original Secondary Outcome Measures ICMJE |
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Current Other Pre-specified Outcome Measures | Not Provided | ||||||||
Original Other Pre-specified Outcome Measures | Not Provided | ||||||||
Descriptive Information | |||||||||
Brief Title ICMJE | RAdiolabeled Perfusion to Identify Coronary Artery Disease Using WAter To Evaluate Responses of Myocardial FLOW (RAPID-WATER-FLOW) | ||||||||
Official Title ICMJE | 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) | ||||||||
Brief 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. | ||||||||
Detailed Description | Not Provided | ||||||||
Study Type ICMJE | Interventional | ||||||||
Study Phase ICMJE | Phase 3 | ||||||||
Study Design ICMJE | Allocation: N/A Intervention Model: Single Group Assignment Intervention Model Description: Approximately 182 evaluable participants with suspected CAD referred for testing will be included in the study. 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). Masking: None (Open Label)Primary Purpose: Diagnostic |
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Condition ICMJE | Coronary Artery Disease | ||||||||
Intervention ICMJE | Drug: [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.
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Study Arms ICMJE | 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).
Intervention: Drug: [O-15]-Water PET Myocardial Perfusion Imaging (MPI)
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Publications * | Not Provided | ||||||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||||||||
Recruitment Status ICMJE | Recruiting | ||||||||
Estimated Enrollment ICMJE |
215 | ||||||||
Original Estimated Enrollment ICMJE | Same as current | ||||||||
Estimated Study Completion Date ICMJE | June 30, 2025 | ||||||||
Estimated Primary Completion Date | December 31, 2024 (Final data collection date for primary outcome measure) | ||||||||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender ICMJE |
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Ages ICMJE | 18 Years and older (Adult, Older Adult) | ||||||||
Accepts Healthy Volunteers ICMJE | No | ||||||||
Contacts ICMJE |
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Listed Location Countries ICMJE | Canada, Denmark, Sweden, United States | ||||||||
Removed Location Countries | |||||||||
Administrative Information | |||||||||
NCT Number ICMJE | NCT05134012 | ||||||||
Other Study ID Numbers ICMJE | MedTrace-002 | ||||||||
Has Data Monitoring Committee | Not Provided | ||||||||
U.S. FDA-regulated Product |
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IPD Sharing Statement ICMJE | Not Provided | ||||||||
Current Responsible Party | MedTrace Pharma A/S | ||||||||
Original Responsible Party | Same as current | ||||||||
Current Study Sponsor ICMJE | MedTrace Pharma A/S | ||||||||
Original Study Sponsor ICMJE | Same as current | ||||||||
Collaborators ICMJE | Not Provided | ||||||||
Investigators ICMJE |
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PRS Account | MedTrace Pharma A/S | ||||||||
Verification Date | April 2024 | ||||||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |