CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 3,000 enrolled
Drug / intervention
Not specified
Likely dose
Not stated in record
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Search/NCT06029387
NCT06029387N/ACompleted

Artificial Intelligence for Preventing Heart Disease: Observational, Single Center, Prospective and Retrospective Study

IRCCS San Raffaele·observational·Posted Sep 8, 2023·Updated Jan 15, 2026

In Brief

An observational study for Coronary Artery Disease. Completed, enrolled 3,000 participants across 1 site.

Detailed Summary

Coronary artery disease (CAD) is a leading cause of mortality in western countries. Coronary computed tomography angiography (cCTA) is the first-line imaging test in patients with suspected obstructive CAD. However, in most patients, cCTA shows non-obstructive CAD. The management of patients with non-obstructive CAD is unclear. This is due to the lack of cCTA-based methods capable to assess the risk of disease progression towards developing major adverse cardiovascular events (MACEs) based on the atherosclerosis characteristics of each patient. A solution for prognostication in these patients is particularly appealing since it could allow to identify patients who can benefit of a more aggressive medical treatment and management, thus improving outcome. Proposed methods, which include qualitative evaluations such as the identification of adverse atherosclerotic plaque characteristics or quantitative evaluations such as the quantification of atherosclerotic plaque burden, may in some cases suffer of limited reproducibility between operators and software. Most importantly, each single biomarker is insufficient to accurately predict patient risk, hence potential synergic integration of cCTA and clinical biomarkers is the key to efficiently guide the personalization of patient's management. Furthermore, the few risk stratification methods that have been proposed are not designed to work on platforms capable of deploying the solution to other clinical settings, promoting prospective or external validation

Study Details

Study Typeobservational
Allocation--
Masking--
Primary Purpose--
CountriesItaly
CollaboratorsDGS, EBIT, Dyrecta Lab, PORINI

Timeline

N/ACompletedFinished
202420252026
First PostedSep 8, 2023
Enrollment StartJul 31, 2023
Primary CompletionNov 14, 2024
TodayJul 2, 2026
Enrollment to primary: 1.3 yearsPosted 2.8 years ago