An observational study in Coronary Artery Disease, sponsored by Zhejiang Hospital. Not yet recruiting at 5 sites in China. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-10-21.
Sponsored by Zhejiang Hospital · Observational
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.
The study uses existing de-identified clinical, laboratory, and serial CCTA data. Eligible participants are adults with coronary plaque, no prior percutaneous coronary intervention or coronary artery bypass grafting, baseline and follow-up CCTA separated by at least 6 months (preferably 12 to 36 months), longitudinally matchable target segments, and adequate image quality. The baseline CCTA will be used for model prediction; the follow-up CCTA will be used for outcome ascertainment. The primary endpoint is definite patient-level non-calcified plaque progression versus non-progression. Annualized change in non-calcified plaque percent atheroma volume will be compared with an MDC95 determined in a 30-50 participant repeatability substudy. Definite progression is greater than +MDC95, stability is within +/- MDC95, and definite reduction/regression is less than -MDC95. Secondary analyses will evaluate prediction of definite plaque reduction/regression, sensitivity, specificity, positive and negative predictive values, F1 score, calibration, Brier score, decision-curve analysis, and plaque-level analyses using generalized estimating equations or mixed-effects models to account for clustering within participants. Analyses will include patient-level cross-validation, center-level validation where feasible, subgroup analyses, and prespecified sensitivity analyses by follow-up interval, scanner/reconstruction protocol, and image quality. Data will be de-identified, encrypted, access-controlled, and analyzed without additional participant procedures or costs.
5,676 studies on the registry are indexed under Coronary Artery Disease; 958 are open to participants now.
This study's planned enrollment of 326 is close to the median of 335 across 1,978 observational studies indexed under Coronary Artery Disease.
Browse Coronary Artery Disease studies →Zhejiang Hospital is the lead sponsor of 9 studies on the registry; 6 are open to participants now.
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Adults with coronary plaque identified from existing clinical records and serial CCTA examinations at participating hospitals. The study uses retrospective, de-identified data and does not require additional examinations, interventions, or costs for participants.
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Exclusion Criteria:
Adults with coronary plaque identified on baseline CCTA and at least one follow-up CCTA. This observational cohort is analyzed using de-identified clinical and imaging data.
Patient-level definite non-calcified plaque progression discrimination (AUC)
Area under the receiver operating characteristic curve (AUC) with 95% confidence interval for the full-system model predicting definite patient-level progression of non-calcified plaque. Definite progression is annualized change in non-calcified plaque percent atheroma volume greater than +MDC95; non-progression includes stability and definite reduction/regression. AUC will be compared with conventional CCTA models using the DeLong test.
Time frame: After completion of follow-up CCTA assessment and database lock (approximately 12-36 months after baseline CCTA).
Prediction of definite non-calcified plaque reduction/regression (AUC and classification metrics)
AUC with 95% confidence interval for predicting definite plaque reduction/regression, with sensitivity, specificity, positive predictive value, negative predictive value, and F1 score.
Time frame: After completion of follow-up CCTA assessment and database lock (approximately 12-36 months after baseline CCTA).
Model calibration (Brier score)
The prespecified quantitative outcome is the Brier score for the full-system and conventional CCTA models, with calibration curves and the Hosmer-Lemeshow test reported as supporting calibration assessments. Prespecified subgroup and sensitivity analyses will assess robustness.
Time frame: After completion of follow-up CCTA assessment and database lock (approximately 12-36 months after baseline CCTA).
Clinical net benefit (decision-curve analysis)
Clinical net benefit of the full-system and conventional CCTA models will be evaluated using decision-curve analysis across prespecified risk-threshold probabilities. Results will be reported as net benefit at each threshold; prespecified subgroup and sensitivity analyses will assess robustness.
Time frame: After completion of follow-up CCTA assessment and database lock (approximately 12-36 months after baseline CCTA).
Plan to share: No
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is not yet recruiting, as verified in Aug 2026. You cannot join it, but the record below documents what was studied.
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Zhejiang Hospital