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Global Pretest Probability Study of Coronary Artery Disease

Study acronym: GPS-CAD
StatusEnrolling by Invitation
PhaseNot specified
Started
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Record History

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  1. Notable Enrollment target: 200000 to 100000
    • Study description revised
    v4
  2. Minor Site details revisedv3
  3. Minor Re-verified, no change to tracked fieldsv2
  4. Minor Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
The use of pre-test probability (PTP) and coronary artery calcium (CAC) scores is guideline-recommended in the evaluation of coronary artery disease (CAD) and stable chest pain. The utility of these scores is population dependent. Previous studies have predominantly been limited to Western populations, despite Asia forming 60% of the global population. However, Asian populations have differing coronary artery phenotypes and may therefore have different PTPs with varying implications for risk stratification. Known difference in CAC implications support a global approach. Hence, this study aims to evaluate a contemporary PTP in diverse real-world Asian, Western and other cohorts and to evaluate the incremental value of CAC in predicting CAD and events. Primarily, the study will compare population specific PTPs and CAC for prediction of coronary computed tomography angiography (CTA) CAD. This could be compared with existing guideline-recommended PTPs alone or with consideration of risk factors or CAC. The study will also evaluate the accuracy of the prediction of major adverse cardiovascular events (MACE) using PTP models, risk factors and/or CAC. Lastly, the study will investigate the accuracy of zero CAC and other minimal risk tools to de-risk cardiovascular disease (CVD) in various populations. The study will investigate multiple international cohorts of patients referred for noninvasive testing using coronary CTA or other non-invasive imaging modalities. Locally-calibrated PTP models in consideration of risk factors or CAC will be separately tailored to each different cohort, and will be evaluated.
Trial Details
NCT Number NCT05722145
Lead Sponsor National Heart Centre Singapore
Conditions
(from sponsor)
Coronary Artery Disease
Related terms Coronary Artery Disease
Enrollment 100,000 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov