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NCT06029387Completed

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

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

Source: ClinicalTrials.gov · Last updated 15 Jan 2026

Brief summary (registry, in English)

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

Status (registry)
Completed
Study type
Observational
Enrollment
3000 (actual)
First submitted
1 Sept 2023
Start date
31 Jul 2023
Primary completion date
14 Nov 2024
Lead sponsor
IRCCS San Raffaele
NCT number
NCT06029387

What you commit to

  • Study type: Observational
  • Participants enrolled: 3000
  • From 31 Jul 2023 to the primary completion date, 14 Nov 2024
  • 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.

Age

  • Age \<18 years old

Other

  • Refusal to participate in the study
  • Presence of other cardiovascular comorbidities (e.g. severe valvulopathies; non-ischemic cardiomyopathies; etc.)

Who the study is looking for

  • Patients with cCTA performed for CAD assessment

Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
IRCCS San Raffaele
Coordinator of this site? Confirm its status
MilanItalyUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.