AI-CCTA for Predicting Cardiovascular Events in CAD

NCT07832175 | Active Not Recruiting

• 1 other identifier: KY20260604-KS-03
• Study Type: observational
• Target: 3,000
• Locations: 1 country
• Sites: 1

Brief Summary

This multicenter, retrospective registry study aims to evaluate the value of artificial intelligence (AI)-derived coronary CT angiography (CCTA) parameters in predicting long-term cardiovascular events in patients with coronary artery disease (CAD). We plan to enroll 3,000 patients from five tertiary hospitals who underwent both CCTA and invasive coronary angiography (ICA) within 90 days. Using ICA and quantitative flow ratio (QFR) as reference standards, we will compare the diagnostic performance of different commercial AI software platforms. Furthermore, we will investigate the association between AI-extracted CCTA multidimensional parameters-including high-risk plaque features, CT-derived fractional flow reserve (CT-FFR), and pericoronary fat attenuation index (FAI)-and major adverse cardiac events (MACE) during over one year of follow-up. We will also explore how lipid-lowering therapies, antiplatelet regimens, and inflammatory biomarkers modify these predictive relationships. This study is expected to provide imaging evidence for personalized risk stratification and optimized clinical decision-making in CAD management.

Conditions

Coronary Artery Disease; Atherosclerotic Cardiovascular Disease

Outcome Measures

Primary Outcomes (1)

• Incidence of Major Adverse Cardiac Events (MACE) at 2 years

  MACE is defined as a composite endpoint including cardiac death, recurrent myocardial infarction, unplanned ischemia-driven revascularization (PCI or CABG), and hospitalization for unstable angina or acute heart failure. The incidence will be calculated as the proportion of participants experiencing at least one MACE event within 24 months after the index CCTA examination. All events will be independently adjudicated by two experienced cardiologists based on original medical records.

  2 years

Secondary Outcomes (2)

• All-cause Mortality at 2 Years

  2 years

• Cardiovascular Mortality at 2 Years

  2 years

Interventions

No intervention OTHER

This is an observational study. No specific interventions are administered by the research team. Participants receive standard diagnostic and therapeutic procedures as per routine clinical practice. The study involves retrospective analysis of existing medical records (CCTA and ICA data) to evaluate the association between AI-derived metrics and clinical outcomes.

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

This multicenter retrospective registry evaluates AI-derived CCTA metrics in 3,000 adults with suspected or confirmed CAD undergoing CCTA and ICA within 90 days across six Chinese tertiary centers. Inclusion criteria: age ≥18 years, ≥12 months follow-up. AI platforms will quantify stenosis, high-risk plaque, CT-FFR, and pericoronary FAI. Baseline demographics, cardiovascular risk factors, biomarkers (lipids, hs-CRP, NT-proBNP), and pharmacotherapies will be assessed. The primary endpoint is MACE over a median 2-year follow-up. Secondary objectives include comparing AI diagnostic accuracy against ICA/QFR and assessing the modifying effects of lipid-lowering intensity and antiplatelet regimens on prognostic stratification. This study aims to establish an integrated anatomical-functional-inflammatory framework for personalized CAD management.

You may qualify if:

• Age ≥18 years at the time of index coronary CT angiography (CCTA).
• Clinically suspected or confirmed coronary artery disease (CAD).
• Underwent both CCTA and invasive coronary angiography (ICA) within 90 days.
• Availability of clinical follow-up data for at least 12 months after the index CCTA.
• Sufficient image quality of CCTA and ICA to allow AI-based analysis and quantitative assessment.
• Signed informed consent or waiver of informed consent approved by the Institutional Review Board (IRB).

You may not qualify if:

• Age \<18 years.
• Poor CCTA image quality precluding reliable AI analysis (e.g., severe motion artifacts, inadequate contrast opacification).
• History of prior coronary artery bypass grafting (CABG).
• Follow-up duration \<12 months or incomplete follow-up records.
• Known hypersensitivity to iodinated contrast media, hyperthyroidism, severe hepatic or renal dysfunction (eGFR \<30 mL/min/1.73m²), or malignancy.
• Pregnancy or lactation at the time of CCTA.
• Incomplete or missing core baseline data (e.g., lack of CCTA/ICA images, key clinical variables, or lipid profiles).

Sponsors & Collaborators

• Nanjing First Hospital, Nanjing Medical University: lead

Study Sites (1)

Nanjing First Hospital, Nanjing Medical University

Nanjing, Jiangsu, 210006, China

Location

MeSH Terms

Conditions

Coronary Artery Disease; Atherosclerosis

Condition Hierarchy (Ancestors)

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

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 22, 2026
• First Posted: September 21, 2026
• Study Start: June 1, 2026
• Primary Completion: August 31, 2026
• Study Completion: October 1, 2026
• Last Updated: September 21, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)