AI Tools Reading Heart Scans to Spot Risky Artery Plaque
Tests AI tools that read heart CT scans to find risky plaque in adults.
Plain-language title generated from the registry record
Registry title: Trustworthy, Integrated Artificial Intelligence Tools for Predicting High-risk CORonary PlaqueS
Key facts
- Where
- Milan, ItalySee the site
Where in Italy
- Centro Cardiologico MonzinoMilan, ItalyTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Centro Cardiologico Monzino
- Trial code
- NCT06410690
- Record updated
- 29 May 2026
- Original description
Coronary artery disease (CAD) is among the leading cause of death and disability. Identification of patients at high risk of cardiovascular events is pivotal. However, current risk stratification based on imaging and known biomarkers is suboptimal. The objective of this proposal is to develop a multicriteria decision model for non-invasive assessment of vulnerable atherosclerotic patients and to evaluate its ability to predict the occurrence of an adverse event in intermediate-to-high risk patients with suspected or known CAD. The planned workflow includes a first step using a retrospective cohort of patients undergoing clinically indicated coronary angiography (CCTA) to develop an integrated application for automatic coronary artery segmentation, quantitative plaque analysis, biomechanics and fluid dynamics, based on machine learning, radiomics and computational analysis approaches and validated against the reference standard for each tool. The second step will apply this new methodology to a larger retrospective cohort of patients with the integration of genomic biomarker assessment to derive the most accurate risk stratification model to properly identify vulnerable patients and vulnerable plaques with respect to outcome. Finally, in the third step, the derived predictive model will be prospectively validated in an independent cohort of patients from an ongoing study (CTP-PRO study) to assess the robustness and accuracy of the proposed solution.Read full original descriptionShow less
Rustworthy, Integrated Artificial Intelligence Tools for Predicting High-risk CORonary PlaqueS
Coronary artery disease (CAD) is among the leading cause of death and disability. Identification of patients at high risk of cardiovascular events is pivotal. However, current risk stratification based on imaging and known biomarkers is suboptimal. The objective of this proposal is to develop a multicriteria decision model for non-invasive assessment of vulnerable atherosclerotic patients and to evaluate its ability to predict the occurrence of an adverse event in intermediate-to-high risk patients with suspected or known CAD. The planned workflow includes a first step using a retrospective cohort of patients undergoing clinically indicated coronary angiography (CCTA) to develop an integrated application for automatic coronary artery segmentation, quantitative plaque analysis, biomechanics and fluid dynamics, based on machine learning, radiomics and computational analysis approaches and validated against the reference standard for each tool. The second step will apply this new methodology to a larger retrospective cohort of patients with the integration of genomic biomarker assessment to derive the most accurate risk stratification model to properly identify vulnerable patients and vulnerable plaques with respect to outcome. Finally, in the third step, the derived predictive model will be prospectively validated in an independent cohort of patients from an ongoing study (CTP-PRO study) to assess the robustness and accuracy of the proposed solution.
Inclusion: 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: performance of any non-invasive diagnostic test within 90 days before enrolment; acute coronary syndrome; cardiac arrhythmias;- presence of a pacemaker or implantable cardioverter defibrillator; low-to-intermediate pre-test likelihood of CAD according to the updated Diamond-Forrester risk model score; evidence of clinical instability; contraindication to contrast agent administration and/or impaired renal function; inability to sustain a breath hold; pregnancy; contraindications to the administration of sublingual nitrates, β-blockers or adenosine; structural cardiomyopathy.