AI tools for predicting high-risk coronary plaques
Rustworthy, Integrated Artificial Intelligence Tools for Predicting High-risk CORonary PlaqueS
This study is testing a new AI tool to see if it can better predict dangerous plaque buildup in the arteries of people with heart disease.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 4000 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Centro Cardiologico Monzino Academic / other |
| Locations | 2 sites (Milan, MI and 1 other locations) |
| Trial ID | NCT06410690 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older with known or suspected CAD who are referred for diagnostic evaluation using advanced CCTA technology.
Not a fit: Patients with low-to-intermediate likelihood of CAD, acute coronary syndrome, or other specific exclusions such as pregnancy or certain cardiac conditions may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly enhance the ability to predict cardiovascular events in high-risk patients, leading to better management and outcomes.
How similar studies have performed: Other studies utilizing AI for cardiovascular risk assessment have shown promise, indicating that this approach may lead to meaningful advancements in patient care.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Milan, MI and 1 other locations
- Centro Cardiologico Monzino — Milan, Mi, Italy (Recruiting)
- Centro Cardiologico Monzino — Milan, Italy (Recruiting)
Study contacts
- Study coordinator: Gianluca Pontone
- Email: gianluca.pontone@cardiologicomonzino.it
- Phone: 0258002574
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.