NCT07886996Not yet recruiting
AI-Based CT Analysis of Coronary Plaque Evolution
Artificial Intelligence-Based CT Analysis of Coronary Plaque Characteristics and Longitudinal Evolution
Source: ClinicalTrials.gov · Last updated 21 Oct 2026
Brief summary (registry, in English)
This retrospective, multicenter, observational study will evaluate an artificial intelligence-based system for quantitative assessment and risk stratification of coronary atherosclerotic plaque. Adults with coronary plaque on baseline coronary CT angiography (CCTA) and at least one follow-up CCTA obtained between January 1, 2020 and December 31, 2025 will be identified from participating centers. The system will integrate clinical factors, CCTA plaque morphology and burden, functional measures, hemodynamic parameters, and biomechanical features using baseline data. Two independent readers will assess conventional CCTA findings, including CAD-RADS and adverse plaque characteristics, while remaining blinded to system outputs. The primary outcome is patient-level definite progression of non-calcified plaque, defined by annualized change in non-calcified plaque percent atheroma volume exceeding the reproducibility-based minimum detectable change (MDC95). Model discrimination will be assessed by area under the receiver operating characteristic curve and compared with conventional CCTA models. Approximately 326 participants are planned.
- Status (registry)
- Not yet recruiting
- Study type
- Observational
- Enrollment
- 326 (estimated)
- First submitted
- 28 Sept 2026
- Start date
- Oct 2026
- Primary completion date
- 31 Dec 2028
- Lead sponsor
- Zhejiang Hospital
- Diseases
- Coronary artery disease
- NCT number
- NCT07886996
What you commit to
- Study type: Observational
- Planned participants: 326
- From Oct 2026 to the primary completion date, 31 Dec 2028
- 5 sites 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
- Prior PCI stent implantation or CABG.
Other illness
- Severe comorbid disease, active malignancy, acute or chronic inflammation, connective tissue or autoimmune disease, or life expectancy less than 1 year.
Lab values
- Image quality or key data judged inadequate by the core laboratory.
Other
- Pregnancy.
- In-stent lesions, complete occlusion, thrombus, left main or ostial lesions, or other lesions preventing the planned hemodynamic or biomechanical analyses.
Who the study is looking for
- Adults aged 18 years or older.
- Baseline CCTA demonstrates coronary plaque in the LAD, LCX, RCA, or a major branch with reference diameter \>=2.0 mm.
- No prior percutaneous coronary intervention or coronary artery bypass grafting.
- Baseline CCTA and at least one follow-up CCTA are available, with an interval of at least 6 months, preferably 12-36 months.
- Target segments can be longitudinally matched and non-calcified plaque volume and total vessel volume can be quantified.
- Image quality meets the core laboratory requirements.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (5)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Sir Run Run Shaw Hospital Zhejiang University School of Medicine Coordinator of this site? Confirm its status | Hangzhou | China | Unknown status |
| The First Affiliated Hospital Zhejiang University School of Medicine Coordinator of this site? Confirm its status | Hangzhou | China | Unknown status |
| Affiliated Hospital of Hangzhou Normal University Coordinator of this site? Confirm its status | Hangzhou | China | Unknown status |
| The Second People's Hospital of Yuhuan City Coordinator of this site? Confirm its status | Yuhuan | China | Unknown status |
| Zhoushan Hospital, Zhejiang Province Coordinator of this site? Confirm its status | Zhoushan | China | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.