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

NCT ID: NCT06410690

Last Updated: 2024-05-13

Basic Information

• Recruitment Status: RECRUITING
• Total Enrollment: 4000 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2023-05-22
• Study Completion Date: 2026-01-22

Brief 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.

Conditions

Coronary Artery Disease; Coronary Computed Tomography Angiography

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: OTHER

Study Groups

Retrospective Cohort

For the retrospective study, we will enrol 3,000 patients \>18 years old who underwent CCTA and meet all of the inclusion and exclusion criteria, with at least 4-year follow-up. The primary endpoint and patient characteristics will be those of the CTP-PRO study. Since women are less affected by CAD, at a ratio of 35:65, to correct for this expected imbalance we will weight recruitment to obtain relatively sex-balanced cohorts. In subgroups of patients, available data from invasive coronary angiography, FFR and OCT will be collected to help develop, test and refine the diagnostic performance of the automated AI tools.

No interventions assigned to this group

Prospective Cohort

The cohort will include subjects prospectively enrolled in the CCTA arm of the CTP-PRO study. The subjects will be followed-up for 24 months after CCTA.

No interventions assigned to this group

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Fondazione IRCCS Policlinico San Matteo di Pavia

OTHER

Sponsor Role: collaborator

Politecnico di Milano

OTHER

Sponsor Role: collaborator

Scientific Institute San Raffaele

OTHER

Sponsor Role: collaborator

Centro Cardiologico Monzino

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Centro Cardiologico Monzino

Milan, MI, Italy

Site Status: RECRUITING

Centro Cardiologico Monzino

Milan, , Italy

Site Status: RECRUITING

Countries

Italy

Central Contacts

Gianluca Pontone

Role: CONTACT

gianluca.pontone@cardiologicomonzino.it

0258002574 ext. +39

Facility Contacts

Chiara Centenaro

Role: primary

Chiara Centenaro

Role: primary

chiara.centenaro@cardiologicomonzino.it

0258002031 ext. +39

Other Identifiers

CCM1890

Identifier Type: -

Identifier Source: org_study_id