AI tools for predicting high-risk coronary plaques

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study aims to develop an integrated artificial intelligence model to assess and predict high-risk coronary plaques in patients with suspected or known coronary artery disease (CAD). It will utilize a retrospective cohort of patients who have undergone coronary computed tomography angiography (CCTA) to create a decision model that incorporates machine learning and computational analysis. The goal is to improve risk stratification and identify patients at higher risk for cardiovascular events more accurately than current methods. The study will validate the AI tools against established standards to ensure their reliability and effectiveness.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* patients (age ≥ 18 years) with known or suspected CAD referred for clinically indicated diagnostic evaluation;
* CCTA performed with state-of-the-art scanner technology, i.e., scanners with more than 64 slices.

Exclusion Criteria:

* performance of any non-invasive diagnostic test within 90 days before enrolment;
* low-to-intermediate pre-test likelihood of CAD according to the updated Diamond-Forrester risk model score;
* acute coronary syndrome;
* evidence of clinical instability;
* contraindication to contrast agent administration and/or impaired renal function;
* inability to sustain a breath hold;
* pregnancy;
* cardiac arrhythmias;- presence of a pacemaker or implantable cardioverter defibrillator;
* contraindications to the administration of sublingual nitrates, β-blockers or adenosine;
* structural cardiomyopathy

Where it's running

• Centro Cardiologico Monzino
  Milan, Milan, Italy Recruiting
• Centro Cardiologico Monzino
  Milan, Mi, Italy Recruiting

Study contacts

• Study coordinator: Gianluca Pontone
• Email: gianluca.pontone@cardiologicomonzino.it
• Phone: 0258002574

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.