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

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorUniversity of Galway

About this trial

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 criteria

This trial accepts healthy volunteers

Qualifiers

Adults aged ≥18 years

Undergoing clinically indicated cardiac CT

Able and willing to provide informed consent

Disqualifiers

History of malignancy

Abnormal renal function (e.g., eGFR or serum creatinine outside reference range)

Contraindications to iodinated contrast agents or CT imaging

Trial population

All-comers adult population undergoing clinically indicated cardiac CT in routine clinical care

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

Not listed

Trial groups

No trial groups listed

Trial outcomes

Primary outcomes

1

Cardiovascular risk stratification using AI-assisted cardiac CT

Assessment of cardiovascular risk based on AI-enhanced cardiac CT imaging, including coronary artery calcium scoring, plaque characterization, and integrated risk prediction using clinical and imaging data.

Time frame
Baseline

Secondary outcomes

1

Correlation between CT-derived plaque characteristics and haematological biomarkers

Association between imaging-derived plaque features and blood biomarkers (e.g., CRP, lipid profile, ApoB/ApoA-1 ratio).

Time frame
Baseline
2

Concordance between coronary CT angiography (CCTA) and optical coherence tomography (OCT)

Agreement between CT-derived plaque characteristics and OCT findings in a subset of participants.

Time frame
Baseline (subset undergoing OCT)
3

Association between lifestyle factors and imaging-derived plaque risk features

ssociation between lifestyle factors (e.g., smoking, diet, occupation) and imaging-derived Parameters.

Time frame
Baseline
4

Subgroup analyses of cardiovascular risk by demographic and clinical factors

Differences in imaging and risk profiles across subgroups (age, sex, comorbidities, hormonal history).

Time frame
Baseline

Other outcomes

1

Development of an anonymized multimodal dataset for AI training and validation

Creation of a secure dataset integrating imaging, clinical, biomarker, and lifestyle data for future AI development.

Time frame
through study completion, up to 10 years

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University of Galway

Lead sponsor

Science Foundation Ireland

Collaborator