An International Study to Evaluate Diagnostic Efficacy of Flurpiridaz (18F) Injection PET MPI in the Detection of Coronary Artery Disease (CAD)
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ClinicalTrials.gov Identifier: NCT03354273 |
Recruitment Status :
Completed
First Posted : November 27, 2017
Results First Posted : July 12, 2023
Last Update Posted : July 12, 2023
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Sponsor:
GE Healthcare
Collaborator:
Pharmaceutical Product Development, LLC
Information provided by (Responsible Party):
GE Healthcare
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Tracking Information | |||||
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First Submitted Date ICMJE | November 21, 2017 | ||||
First Posted Date ICMJE | November 27, 2017 | ||||
Results First Submitted Date ICMJE | May 4, 2023 | ||||
Results First Posted Date ICMJE | July 12, 2023 | ||||
Last Update Posted Date | July 12, 2023 | ||||
Actual Study Start Date ICMJE | June 5, 2018 | ||||
Actual Primary Completion Date | May 5, 2022 (Final data collection date for primary outcome measure) | ||||
Current Primary Outcome Measures ICMJE |
Sensitivity and Specificity of Flurpiridaz (18F) Injection Positron Emission Tomography (PET) Myocardial Perfusion Imaging (MPI) in the Detection of Significant Coronary Artery Disease (CAD) as Defined by Cardiac Catheterization [ Time Frame: Up to 60 days ] Sensitivity was defined as true positives (TP)/(TP+false negatives [FN]). TP was participants with abnormal PET MPI and disease positive by truth standard and FN was participants with normal PET MPI and disease positive by truth standard. Specificity defined as true negatives (TN)/(TN+ false positives [FP]). TN was participants with normal PET MPI and disease negative by truth standard and FP was participants with abnormal PET MPI and disease negative by truth standard. Truth standard was presence of CAD as evidenced by presence of stenosis of >=50 percent (%) in >=1 coronary artery or major branch of a coronary artery as determined by quantitative coronary angiography (QCA) analysis. Participants were considered to have CAD if QCA revealed >=50% stenosis of >=1 major coronary artery or major branch. Sensitivity and specificity were calculated for 3 readers and majority rule using each participant judgement (positive or negative) by at least 2 of 3 readers.
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Original Primary Outcome Measures ICMJE |
Diagnostic efficacy of Flurpiridaz (18F) Injection PET MPI in the detection of significant CAD [ Time Frame: 60 days ] Defined by invasive coronary angiography, in patients with suspected 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 | An International Study to Evaluate Diagnostic Efficacy of Flurpiridaz (18F) Injection PET MPI in the Detection of Coronary Artery Disease (CAD) | ||||
Official Title ICMJE | A Phase 3, Open-Label, Multicentre Study of Flurpiridaz (18F) Injection for Positron Emission Tomography (PET) Imaging for Assessment of Myocardial Perfusion in Patients Referred for Invasive Coronary Angiography Because of Suspected Coronary Artery Disease | ||||
Brief Summary | This is a Phase 3, prospective, open-label, international, multicentre study of Flurpiridaz (18F) Injection for PET MPI in patients referred for ICA because of suspected CAD. | ||||
Detailed Description | Not Provided | ||||
Study Type ICMJE | Interventional | ||||
Study Phase ICMJE | Phase 3 | ||||
Study Design ICMJE | Allocation: N/A Intervention Model: Single Group Assignment Masking: None (Open Label) Primary Purpose: Diagnostic |
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Condition ICMJE | Coronary Artery Disease (CAD) | ||||
Intervention ICMJE |
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Study Arms ICMJE | Experimental: 1
Flurpiridaz PET MPI (following off-study SPECT MPI)
Interventions:
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Publications * | Bourque JM, Hanson CA, Agostini D, Bateman TM, Bax JJ, Beanlands RSB, Berman DS, Garcia EV, Heller GV, Knuuti J, Tamaki N, Udelson JE, Maddahi J. Assessing myocardial perfusion in suspected coronary artery disease: rationale and design of the second phase 3, open-label multi-center study of flurpiridaz (F-18) injection for positron emission tomography (PET) imaging. J Nucl Cardiol. 2021 Jun;28(3):1105-1116. doi: 10.1007/s12350-021-02527-8. Epub 2021 Jan 31. | ||||
* 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 | Completed | ||||
Actual Enrollment ICMJE |
730 | ||||
Original Estimated Enrollment ICMJE |
522 | ||||
Actual Study Completion Date ICMJE | May 5, 2022 | ||||
Actual Primary Completion Date | May 5, 2022 (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 | Contact information is only displayed when the study is recruiting subjects | ||||
Listed Location Countries ICMJE | Canada, Finland, France, Germany, Netherlands, Switzerland, United States | ||||
Removed Location Countries | |||||
Administrative Information | |||||
NCT Number ICMJE | NCT03354273 | ||||
Other Study ID Numbers ICMJE | GE-265-303 2017-005011-14 ( EudraCT Number ) |
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Has Data Monitoring Committee | Yes | ||||
U.S. FDA-regulated Product |
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IPD Sharing Statement ICMJE | Not Provided | ||||
Current Responsible Party | GE Healthcare | ||||
Original Responsible Party | Same as current | ||||
Current Study Sponsor ICMJE | GE Healthcare | ||||
Original Study Sponsor ICMJE | Same as current | ||||
Collaborators ICMJE | Pharmaceutical Product Development, LLC | ||||
Investigators ICMJE |
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PRS Account | GE Healthcare | ||||
Verification Date | June 2023 | ||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |