NCT06410690Recruiting
Trustworthy, Integrated Artificial Intelligence Tools for Predicting High-risk CORonary PlaqueS
Rustworthy, Integrated Artificial Intelligence Tools for Predicting High-risk CORonary PlaqueS
Source: ClinicalTrials.gov · Last updated 29 May 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Observational
- Enrollment
- 4000 (estimated)
- First submitted
- 25 Mar 2024
- Start date
- 22 May 2023
- Primary completion date
- 30 Nov 2026
- Lead sponsor
- Centro Cardiologico Monzino
- Diseases
- Coronary artery disease
- NCT number
- NCT06410690
What you commit to
- Study type: Observational
- Planned participants: 4000
- From 22 May 2023 to the primary completion date, 30 Nov 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- performance of any non-invasive diagnostic test within 90 days before enrolment;
Other illness
- acute coronary syndrome;
- cardiac arrhythmias;- presence of a pacemaker or implantable cardioverter defibrillator;
Other
- low-to-intermediate pre-test likelihood of CAD according to the updated Diamond-Forrester risk model score;
- evidence of clinical instability;
- contraindication to contrast agent administration and/or impaired renal function;
- inability to sustain a breath hold;
- pregnancy;
- contraindications to the administration of sublingual nitrates, β-blockers or adenosine;
- structural cardiomyopathy
Who the study is looking for
- 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.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Centro Cardiologico Monzino Coordinator of this site? Confirm its status | Milan | Italy | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.