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
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 design
Treatments tested in this trial
- Not listed
Trial groups
Sponsors and collaborators
Centro Cardiologico Monzino
Lead sponsor
Fondazione IRCCS Policlinico San Matteo di Pavia
Collaborator
Politecnico di Milano
Collaborator
Scientific Institute San Raffaele
Collaborator