Coronary Artery DiseaseAI-CORPSNCT06410690
Trustworthy, Integrated Artificial Intelligence Tools for Predicting High-risk CORonary PlaqueS
An observational study of Coronary Artery Disease and Coronary Computed Tomography Angiography, run by Centro Cardiologico Monzino at 2 sites in Italy.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Coronary Artery Disease, Coronary Computed Tomography Angiography
- How many people
- 4,000 participants
- Where
- 2 sitesItaly
- Study dates
- 22 May 2023to 30 Nov 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients who performed CCTA and meet all inclusion criteria
Who may be able to join
- 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.
Who cannot join
- 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;
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- pregnancy;
- cardiac arrhythmias;- presence of a pacemaker or implantable cardioverter defibrillator;
- contraindications to the administration of sublingual nitrates, β-blockers or adenosine;
- structural cardiomyopathy
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Italy2 sites, 2 recruiting
- Recruiting
Centro Cardiologico Monzino
Milan, Milan, 20131
Chiara Centenaro, 0258002031 ext. +39, chiara.centenaro@cardiologicomonzino.it
- Recruiting
Centro Cardiologico Monzino
Milan, MI, 20131
Chiara Centenaro
About this study
Official title: Rustworthy, Integrated Artificial Intelligence Tools for Predicting High-risk CORonary PlaqueS
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.
- Medical subject headings
- Coronary Artery Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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. | |
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: January 2026
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
Measured: January 2026
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 May 2024
- Study start22 May 2023
- Primary completion30 Nov 2026 (estimated)
- Study completion30 Nov 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Coronary Artery DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Other
- Enrolment
- 4,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centro Cardiologico Monzino
- Sponsor type
- University, hospital or other
- Collaborators
- Fondazione IRCCS Policlinico San Matteo di Pavia, Politecnico di Milano, Scientific Institute San Raffaele
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06410690
- Sponsor's protocol ID
- CCM1890
- Acronym
- AI-CORPS
- Status last verified
- Jan 2026
- First submitted
- 25 Mar 2024
- Last updated
- 29 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Rustworthy, Integrated Artificial Intelligence Tools for Predicting High-risk CORonary PlaqueS
- ClinicalTrials.gov ID
- NCT06410690
- Acronym / sponsor ID
- AI-CORPS / CCM1890
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 4,000 participants (estimated)
- Lead sponsor
- Centro Cardiologico MonzinoUniversity, hospital or other
- Collaborators
- Fondazione IRCCS Policlinico San Matteo di Pavia, Politecnico di Milano, Scientific Institute San Raffaele
- Study start
- 22 May 2023 (actual)
- Primary completion
- 30 Nov 2026 (estimated)
- Study completion
- 30 Nov 2026 (estimated)
- First posted
- 13 May 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Other
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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. |
| 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients who performed CCTA and meet all inclusion criteria
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (10 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
Time frame: January 2026
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)
Quantitative assessment of the atherosclerotic burden and high risk plaque features
Time frame: January 2026
* 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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 May 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Coronary Artery Disease and Coronary Computed Tomography Angiography, run by Centro Cardiologico Monzino at 2 sites in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 29 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Gianluca Pontone (0258002574 ext. +39, gianluca.pontone@cardiologicomonzino.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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 (time frame: January 2026). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 May 2026.