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

Status: Recruiting
Location: See location...
Study Type: Observational
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

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• Patients with cCTA performed for CAD assessment

Locations
Other Locations
Italy
IRCCS San Raffaele
RECRUITING
Milan
Contact Information
Primary
Antonio Esposito
esposito.antonio@hsr.it
02 2643 6102
Backup
Davide Vignale
vignale.davide@hsr.it
02 2643 6113
Time Frame
Start Date: 2023-07-31
Estimated Completion Date: 2028-03-01
Participants
Target number of participants: 3000
Treatments
Retrospective cohort
The retrospective cohort will include 2500 patients who underwent a clinically indicated cCTA examination for CAD evaluation.~Duration of enrollment: enrollment of patients via a telephone call will last 15 months starting from the beginning of the study (month 0).~Duration of total follow-up: no follow-up is planned. Duration of total study period: total retrospective study duration will be 30 months
Prospective cohort
The prospective cohort will include 500 patients undergoing a clinically indicated cCTA for CAD evaluation.~Duration of enrollment: enrollment of patients at the time of cCTA examination will last 12 months.~Duration of total follow-up: each patient will be followed up for 36 months from the date of the cCTA.~Duration of total study period: total prospective study duration will be 54 months (last patient enrolled at month 12 + 36 months of follow-up + 6 months for data analysis).
Related Therapeutic Areas
Sponsors
Collaborators: Dyrecta Lab, EBIT, DGS, PORINI
Leads: IRCCS San Raffaele

This content was sourced from clinicaltrials.gov