RecruitingNCT07169201

High-Resolution CT for Heart

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


Sponsor

Shanghai Zhongshan Hospital

Enrollment

500 participants

Start Date

Sep 1, 2025

Study Type

OBSERVATIONAL

Conditions

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

Min Age: 18 Years

Inclusion Criteria1

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

Exclusion Criteria1

  • those can not undergo CTA and angiography

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Interventions

DIAGNOSTIC_TESTAngiography based RWS and OCT based plaque characteristcis

Angiography based RWS and OCT based plaque characteristcis


Locations(1)

Zhongshan Hospital Fudan University

Shanghai, Shanghai Municipality, China

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NCT07169201


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