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

Coronary Artery Disease Clinical Trial

— AI-CORPS  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06410690
• Other study ID #: CCM1890
• Status: Recruiting
• Start date: May 22, 2023
• Est. completion date: January 22, 2026

Study information

• Verified date: March 2024
• Source: Centro Cardiologico Monzino
• Contact: Gianluca Pontone
• Phone: 0258002574
• Email: gianluca.pontone[@]cardiologicomonzino.it
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 4000
• Est. completion date: January 22, 2026
• Est. primary completion date: January 22, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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, ß-blockers or adenosine;

• structural cardiomyopathy

Related Conditions & MeSH terms

• Coronary Artery Disease
• Coronary Computed Tomography Angiography

Locations

Country	Name	City	State
Italy	Centro Cardiologico Monzino	Milan	MI
Italy	Centro Cardiologico Monzino	Milan

Sponsors (4)

Lead Sponsor	Collaborator
Centro Cardiologico Monzino	Fondazione IRCCS Policlinico San Matteo di Pavia, Politecnico di Milano, Scientific Institute San Raffaele

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)	January 2026
Primary	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	January 2026