Actively Recruiting

Age: 18Years +
All Genders
Healthy Volunteers
ID07577609

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

Led by University of Galway · Updated on 2026-05-11

10000

Participants Needed

1

Research Sites

N/A

Total Duration

On this page

Sponsors

U

University of Galway

Lead Sponsor

S

Science Foundation Ireland

Collaborating Sponsor

AI-Summary

What this Trial Is About

Researchers are evaluating whether artificial intelligence (AI)-assisted cardiac CT imaging can improve the prediction of cardiovascular risk and future coronary events in adults undergoing medically needed cardiac CT scans. This observational study aims to understand how AI-enhanced cardiac CT assesses risk in a real-world adult population, and how CT-derived plaque features relate to clinical, biochemical, and lifestyle factors. It also compares subgroups, including those undergoing additional imaging like optical coherence tomography (OCT), to explore associations with cardiovascular risk and plaque vulnerability. Participants will have a single baseline visit where demographic and medical data are collected, including blood samples for cardiovascular and metabolic biomarkers, a resting ECG, and a lifestyle and health questionnaire. They will receive a non-invasive cardiac CT scan interpreted by experts, with some possibly receiving heart rate-lowering medication if needed for image quality. A subset undergoing invasive imaging will provide additional data for comparison. Data collection follows strict quality assurance and privacy procedures. Throughout the study, researchers will gather detailed clinical, imaging, laboratory, and lifestyle information, with data securely stored and anonymized. Outcome measures include cardiovascular risk stratification using AI-assisted cardiac CT and correlations between imaging findings and biomarkers. Some participants will be followed longitudinally for up to 5 years to observe plaque changes under statin therapy. The study supports advanced risk modeling and precision medicine approaches, with participant involvement limited to a single baseline visit unless additional imaging or follow-up data are available.

CONDITIONS

Brief Title

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

Who Can Participate

Age: 18Years +
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Adults aged 6518 years
  • Undergoing clinically indicated cardiac CT
  • Able and willing to provide informed consent
Not Eligible

You will not qualify if you...

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

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person) at time of referral for cardiac CT

Diagnostic Evaluation

Duration - Single baseline visit

Participants undergo clinically indicated cardiac CT and related baseline assessments including blood sampling, ECG, questionnaires, and data collection from medical records.

1 baseline visit (in-person)

Long-term Monitoring

Duration - Up to 5 years

Participants are followed up with routine clinical data collection and assessments to monitor cardiovascular risk and changes in plaque composition over time.

Annual visits up to 5 years for follow-up assessments

Trial Site Locations

Total: 1 location

1

Clinical Research Facility

Galway, Ireland

Actively Recruiting

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Research Team

F

Faisal Sharif

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

0

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