AI-assisted cardiac CT to predict coronary artery disease risk
Artificial Intelligence-assisted CT for Risk Stratification in COronary Artery Disease to PreveNt Future Coronary Events and Improve Outcomes
This project will try using AI-enhanced heart CT scans to better predict future coronary events in adults who are already getting a clinical cardiac CT.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 10000 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University of Galway Academic / other |
| Locations | 1 site (Galway) |
| Trial ID | NCT07577609 on ClinicalTrials.gov |
What this trial studies
The ACTION Registry is a prospective, single-centre observational registry at University Hospital Galway that collects multimodal data from adults undergoing clinically indicated cardiac CT. Participants provide consent and give demographic and clinical information, blood samples for cardiovascular and metabolic biomarkers, a resting ECG, and complete lifestyle and risk-factor questionnaires while their standard-of-care cardiac CT is acquired and interpreted. Imaging data, including CT-derived plaque characteristics and a subset with invasive OCT, will be integrated with biochemical and clinical variables for AI-based analyses to stratify cardiovascular risk and explore plaque vulnerability. Data are collected at a baseline visit with routine clinical follow-up information added where available.
Who should consider this trial
Good fit: Adults aged 18 or older who are referred for clinically indicated cardiac CT, can give informed consent, and meet standard safety criteria (e.g., normal renal function and no contraindication to iodinated contrast) are ideal candidates.
Not a fit: People with a history of malignancy, abnormal renal function, contraindication to iodinated contrast, or those not undergoing clinically indicated cardiac CT are unlikely to participate or benefit from this registry.
Why it matters
Potential benefit: If successful, this approach could help clinicians identify people at higher risk of coronary events earlier and tailor prevention strategies more precisely.
How similar studies have performed: Previous studies have shown promising results for AI-enhanced CCTA in plaque characterization and risk prediction, but large real-world registries validating clinical utility remain limited.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Adults aged ≥18 years * Undergoing clinically indicated cardiac CT * Able and willing to provide informed consent Exclusion Criteria: * History of malignancy * Abnormal renal function (e.g., eGFR or serum creatinine outside reference range) * Contraindications to iodinated contrast agents or CT imaging
Where this trial is running
Galway
- Clinical Research Facility — Galway, Ireland (Recruiting)
Study contacts
- Principal investigator: Faisal Sharif, MBBS, PhD, FRCPI, FESC, FACC — University of Galway
- Study coordinator: Faisal Sharif
- Email: faisal.sharif@universityofgalway.ie
- Phone: +353 91524222
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.