Global Pretest Probability Study of Coronary Artery Disease

NCT05722145 | Enrolling By Invitation

• 1 other identifier: 2022-2521
• Study Type: observational
• Target: 100,000
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Coronary Artery Disease

Outcome Measures

Primary Outcomes (1)

• To evaluate and optimize contemporary risk and PTP tools for use in diverse real-world global cohorts by pooling data from multiple large CTA/CAC studies worldwide

  Throughout study, expected to be 5 years

Secondary Outcomes (4)

• To evaluate and compare existing PTPs and CAC for prediction of CTA-defined CAD using PTP alone, with risk factors (RF) and/or CAC

  Throughout study, expected to be 5 years

• To compare the accuracy of prediction of major adverse cardiovascular events (MACE) using PTP alone, with RF and/or CAC

  Throughout study, expected to be 5 years

• Determine population-specific optimizations for risk prediction of CAD and MACE and evaluate these newly-modified PTP

  Throughout study, expected to be 5 years

• To compare accuracy of zero CAC and minimal risk tools to exclude CAD in various populations (de-risk)

  Throughout study, expected to be 5 years

Eligibility Criteria

• Age: 21 Years - 99 Years
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Across hospitals and research centres across multiple countries

You may qualify if:

• Age of participants are more than or equals to 21 years old
• The subjects need to have underwent computed tomography angiography (CTA) or non-contrast computer tomography (NCCT) for assessment of coronary artery disease.

You may not qualify if:

• Age less than 21 years old
• Subjects who are unable to undergo cardiac CT

Sponsors & Collaborators

• National Heart Centre Singapore: lead

Study Sites (1)

National Heart Centre Singapore

Singapore, Singapore, 169609, Singapore

Location

Related Publications (1)

• Baskaran L, Selva JJ, Mantri AVI, Douglas PS; GPS-CAD Investigators. Design and Rationale of GPS-CAD: Global Pretest Probability Study of Coronary Artery Disease. JACC Asia. 2025 Dec 30:S2772-3747(25)00695-7. doi: 10.1016/j.jacasi.2025.11.016. Online ahead of print.

  PMID: 41904715 DERIVED

MeSH Terms

Conditions

Coronary Artery Disease

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases

Study Officials

• Lohendran Baskaran

  National Heart Centre Singapore

  PRINCIPAL INVESTIGATOR

• Pamela Douglas

  Duke University

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 9, 2023
• First Posted: February 10, 2023
• Study Start: November 25, 2022
• Primary Completion (Estimated): August 1, 2027
• Study Completion (Estimated): August 1, 2027
• Last Updated: December 4, 2025

Record last verified: 2025-05

Locations

SG (1)