Trustworthy, Integrated Artificial Intelligence Tools for Predicting High-risk CORonary PlaqueS
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Coronary Artery Disease, Coronary Computed Tomography Angiography. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Italy
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Rustworthy, Integrated Artificial Intelligence Tools for Predicting High-risk CORonary PlaqueS
Overview
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.
Primary outcome measures
- Creation of an automated integrative artificial intelligence (AI) approach for the stratification of CAD patients and assessment of vulnerable coronary plaques at risk of acute complications [Time frame: January 2026]
- Quantitative assessment of the atherosclerotic burden and high risk plaque features [Time frame: January 2026]
Eligibility 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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
Italy · 2 centers
- Centro Cardiologico Monzino — Milan
- Centro Cardiologico Monzino — Milan
Identifiers
NCT: NCT06410690 · CCM1890