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

NCT06029387 | Completed

• 1 other identifier: AiPHD F/310003/01/X56
• Study Type: observational
• Target: 3,000
• Locations: 1 country
• Sites: 1

Brief 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

Conditions

Coronary Artery Disease

Keywords

Coronary Computed Tomography Angiography; Major adverse cardiovascular events; Artificial Intelligence; Proportional Hazards

Outcome Measures

Primary Outcomes (1)

• composite outcome 1

  death by cardiovascular events or non-fatal myocardial infarction

  36 months from CCTA examination

Secondary Outcomes (1)

• composite outcome 2

  36 months from CCTA examination

Other Outcomes (1)

• change of atherosclerotic burden

  12 months from CCTA examination

Study Arms (2)

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).

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 cCTA performed for CAD assessment

You may not qualify if:

• Refusal to participate in the study
• Age \<18 years old
• Presence of other cardiovascular comorbidities (e.g. severe valvulopathies; non-ischemic cardiomyopathies; etc.)

Sponsors & Collaborators

• IRCCS San Raffaele: lead
• DGS: collaborator
• EBIT: collaborator
• Dyrecta Lab: collaborator
• PORINI: collaborator

Study Sites (1)

IRCCS San Raffaele

Milan, 20132, Italy

Location

Related Publications (17)

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MeSH Terms

Conditions

Coronary Artery Disease

Condition Hierarchy (Ancestors)

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

Study Officials

• Antonio Esposito

  IRCCS San Raffaele

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: OTHER
• 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: November 14, 2024
• Study Completion: November 14, 2024
• Last Updated: January 15, 2026

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)