NCT07832175Active, not recruiting
AI-CCTA for Predicting Cardiovascular Events in CAD
Multicenter Al-derived CCTA Parameters for Predicting Long-term Cardiovascular Events in Coronary Artery Disease: A Retrospective Registry Study
Source: ClinicalTrials.gov · Last updated 21 Sept 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Active, not recruiting
- Study type
- Observational
- Enrollment
- 3000 (estimated)
- First submitted
- 22 Jul 2026
- Start date
- 1 Jun 2026
- Primary completion date
- 31 Aug 2026
- Lead sponsor
- Nanjing First Hospital, Nanjing Medical University
- Diseases
- Coronary artery disease
- NCT number
- NCT07832175
What you commit to
- Study type: Observational
- Planned participants: 3000
- From 1 Jun 2026 to the primary completion date, 31 Aug 2026
- 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.
Prior treatment
- History of prior coronary artery bypass grafting (CABG).
Lab values
- Known hypersensitivity to iodinated contrast media, hyperthyroidism, severe hepatic or renal dysfunction (eGFR \<30 mL/min/1.73m²), or malignancy.
Age
- Age \<18 years.
Other
- Poor CCTA image quality precluding reliable AI analysis (e.g., severe motion artifacts, inadequate contrast opacification).
- Follow-up duration \<12 months or incomplete follow-up records.
- 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).
Who the study is looking for
- 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).
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Nanjing First Hospital, Nanjing Medical University Coordinator of this site? Confirm its status | Nanjing | China | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.