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A High-Temporal Resolution CT Platform for Imaging and Functional Evaluation of Heart

Status: Recruiting

Location: See location...

Intervention Type: Diagnostic test

Study Type: Observational

SUMMARY

This prospective observational study aims to evaluate a high-resolution coronary CT platform (uCT SiriuX Pro) for non-invasive assessment of coronary plaque biomechanics and functional physiology in high-risk patients. The system enables CT-derived radial wall strain (CT-RWS), a novel biomarker reflecting plaque vulnerability, with potential correlation to invasive OCT findings and clinical outcomes. The study will assess the diagnostic performance and prognostic value of CT-RWS, along with a new CT-based index of systolic flow perfusion (CT-SFPR) for evaluating the hemodynamic relevance of myocardial bridging, compared to nuclear perfusion imaging. Additionally, left ventricular ejection fraction derived from dynamic CTA (CT-EF) will be compared with echocardiography to evaluate its feasibility and accuracy. This is the first study to comprehensively validate CT-RWS, CT-SFPR, and CT-EF using a fully non-invasive, high-temporal-resolution CT platform.

Eligibility

Participation Requirements

Sex: All

Minimum Age: 18

Healthy Volunteers: f

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• Adults ≥18 years with suspected or known CAD or with type 2 diabetes

Locations

Other Locations

China

Zhongshan Hospital Fudan University

RECRUITING

Shanghai

Time Frame

Start Date: 2025-09-01

Estimated Completion Date: 2030-06-30

Participants

Target number of participants: 500

Treatments

Cohort for CT-RWS

This cohort includes patients with suspected or known coronary artery disease undergoing coronary CTA using a high-temporal-resolution CT scanner (uCT SiriuX Pro). Patients must have at least one lesion with moderate-to-severe stenosis (≥50%) on CTA. All participants will subsequently undergo invasive coronary angiography and OCT. The study aims to assess the correlation between CT-derived radial wall strain (CT-RWS) and OCT-defined plaque vulnerability features, including thin-cap fibroatheroma (TCFA), lipidic plaque burden, and lipid-to-cap ratio (LCR). CT-RWS will be derived from coronary CTA using a dedicated algorithm. OCT will serve as the invasive reference for plaque characterization. No investigational drug or device will be used. Lesion-level comparisons will evaluate whether CT-RWS can serve as a non-invasive surrogate of plaque biomechanics.

Cohort for myocardial bridging

This cohort includes patients with myocardial bridging (MB) identified on coronary CTA using a high-temporal-resolution CT scanner (uCT SiriuX Pro). Patients must have symptoms suggestive of ischemia and elevated systolic flow perfusion ratio (CT-SFPR), a novel CT-based index designed to quantify dynamic systolic compression of the bridged coronary segment. Eligible patients will undergo invasive coronary angiography with physiological assessment using resting full-cycle ratio (RFR) to evaluate the functional significance of MB. The primary objective is to assess the correlation between CT-SFPR and invasively measured RFR. CT-SFPR will be calculated from multiphase coronary CTA using a dedicated post-processing algorithm. No investigational drugs or devices are involved. The cohort aims to validate CT-SFPR as a non-invasive marker for MB-related ischemia.

Cohort for prognosis

This cohort includes patients with suspected or known coronary artery disease who undergo coronary CTA using a high-temporal-resolution CT scanner (uCT SiriuX Pro). CT-derived radial wall strain (CT-RWS) will be calculated for coronary lesions using a dedicated post-processing algorithm. All patients will be followed prospectively for up to 2 years to monitor the occurrence of major adverse cardiovascular events (MACE), including cardiac death, non-fatal myocardial infarction, and target vessel revascularization. The primary objective is to assess the prognostic value of CT-RWS for predicting future cardiovascular events. CT-RWS will be analyzed both as a continuous variable and based on predefined thresholds to identify high-risk plaque biomechanics. No investigational interventions will be applied. This cohort aims to validate CT-RWS as a non-invasive imaging biomarker for long-term risk stratification.

Related Therapeutic Areas

Congenital Coronary Artery Malformation

Coronary Heart Disease

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