Trustworthy, Integrated Artificial Intelligence Tools for Predicting High-risk CORonary PlaqueS

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorCentro Cardiologico Monzino

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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;

Trial population

Patients who performed CCTA and meet all inclusion criteria

Trial design

Design model

Cohort

Time perspective

Other

Treatments tested in this trial

Not listed

Trial groups

4,000 Participants
are grouped into 2 trial groups
Group A: Retrospective Cohort
Group B: Prospective Cohort

Trial outcomes

Primary outcomes

1

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

The main aim of the project develop a multicriteria decision model for the automatic (AI-assisted) non-invasive assessment of vulnerable atherosclerotic patients and evaluate the ability of this model to predict the occurrence of adverse event in intermediate-to-high risk patients with suspected or known CAD. As adverse events, we will consider the annual rate of events, intended as death or hospitalization for revascularization (either CABG or PCI)

Time frame
January 2026
2

Quantitative assessment of the atherosclerotic burden and high risk plaque features

* Extent and severity of coronary atherosclerosis (Leaman Score, number of lesions); * Vulnerability indices: plaque burden (total plaque volume, plaque density), LAP, PR, NRS and SC; * Fluid dynamic indexes of the coronary artery such as the CT derived Fractional Flow Reserve

Time frame
January 2026

Secondary outcomes

Other outcomes

Sponsors and contacts

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Centro Cardiologico Monzino

Lead sponsor

Fondazione IRCCS Policlinico San Matteo di Pavia

Collaborator

Politecnico di Milano

Collaborator

Scientific Institute San Raffaele

Collaborator