RecruitingNCT07577609

AI-assisted CT for Risk Stratification in Coronary Artery Disease (ACTION)

Artificial Intelligence-assisted CT for Risk Stratification in COronary Artery Disease to PreveNt Future Coronary Events and Improve Outcomes


Sponsor

University of Galway

Enrollment

10,000 participants

Start Date

Dec 21, 2022

Study Type

OBSERVATIONAL

Conditions

Summary

The goal of this observational study is to learn if AI-assisted cardiac CT imaging can improve cardiovascular risk stratification and prediction of future coronary events in an adult population undergoing clinically indicated cardiac CT. The main questions it aims to answer are: * Can AI-enhanced cardiac CT accurately assess cardiovascular risk in a real-world adult population? * How do CT-derived plaque characteristics correlate with clinical, biochemical, and lifestyle risk factors? Researchers will compare subgroups (e.g., patients with different risk profiles, biomarkers, or imaging findings, and a subset undergoing OCT imaging) to see if differences in imaging and clinical parameters are associated with cardiovascular risk and plaque vulnerability. Participants will: * Provide informed consent and medical history/demographic information * Undergo blood sampling for cardiovascular and metabolic biomarkers * Have a resting ECG performed * Complete a detailed lifestyle and health questionnaire * Receive a non-invasive cardiac CT scan interpreted by an expert * Potentially receive heart rate-lowering medication (e.g., metoprolol) if required for imaging quality * Be referred for further clinical evaluation if clinically indicated 


Eligibility

Min Age: 18 Years

Inclusion Criteria3

  • Adults aged ≥18 years
  • Undergoing clinically indicated cardiac CT
  • Able and willing to provide informed consent

Exclusion Criteria3

  • History of malignancy
  • Abnormal renal function (e.g., eGFR or serum creatinine outside reference range)
  • Contraindications to iodinated contrast agents or CT imaging

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Locations(1)

Clinical Research Facility

Galway, Ireland

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NCT07577609


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