Peri-luminal COROnary CTa AI-driven radiOMICS to Identify Vulnerable Patients (CORO-CTAIOMICS)

NCT06029777 | Completed

• 1 other identifier: PNRR-MAD-2022-12376633
• Study Type: observational
• Target: 2,190
• Locations: 1 country
• Sites: 1

Brief Summary

CAD is a leading cause of mortality in Europe. cCTA is recommended to rule out obstructive CAD, but, in most patients, it shows non-obstructive CAD. The management of these patients is unclear due to lack of reproducible quantitative measurement, beyond stenosis severity, capable to assess the risk of disease progression towards developing MACEs. To improve identification and phenotypization of patients at high risk of disease progression, the investigators propose the application of artificial intelligence algorithms to cCTA images to automatically extract periluminal radiomics features to characterize the atherosclerotic process. By leveraging machine-learning empowered radiomics the investigators aim to improve patients' risk stratification in a robust, quantitative and reproducible fashion. By developing a novel quantitative AI based cCTA measure, the investigators expect to provide a risk score capable to identify patients who can benefit of a more aggressive medical treatment and management, thus improving outcome

Conditions

Coronary Artery Disease

Keywords

Coronary artery disease; Computed Tomography; Radiomic; Artificial Intelligence; Risk assessment; Major adverse cardiac events

Outcome Measures

Primary Outcomes (1)

• Composite outcome

  All-cause mortality, myocardial infarction, due to unstable angina or heart hospitalization failure, late coronary revascularization

  48 months from CCTA

Study Arms (1)

Retrospective cohort

The retrospective cohort will include 2190 patients who underwent a clinically indicated cCTA between 2017 and 2019 at the Radiology Unit of San Raffaele Hospital. No other interventions will be performed. Patients will be solely contacted via a telephone call to assess their clinical status.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients undergoing clinically indicated cCTA for suspected CAD.

You may qualify if:

• Patients with CT performed for CAD assessment between 2017 and 2019.
• Follow-up duration of at least 4 years.

You may not qualify if:

• Refusal to participate in the study
• Age \<18 years old
• History of previous coronary revascularization
• Presence of other cardiovascular comorbidities (e.g. inflammatory cardiomyopathy, valvular cardiomyopathy, idiopathic dilated cardiomyopathy, infiltrative cardiomyopathy)

Sponsors & Collaborators

• IRCCS San Raffaele: lead
• Ministry of Health, Italy: collaborator

Study Sites (1)

IRCCS San Raffaele

Milan, 20132, Italy

Location

Related Publications (13)

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MeSH Terms

Conditions

Coronary Artery Disease; Cardiovascular Diseases

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: September 1, 2023
• First Posted: September 8, 2023
• Study Start: July 31, 2023
• Primary Completion: September 24, 2024
• Study Completion: September 24, 2024
• Last Updated: January 15, 2026

Record last verified: 2026-01

Locations

IT (1)