Clinical trial Recruiting at 1 site Observational Ages 18 and up

High-resolution coronary CT for plaque biomechanics and heart function

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

Run by Shanghai Zhongshan Hospital · NCT07169201 · Data updated 2026-11-12

This trial tests whether a new high-temporal-resolution coronary CT scan can noninvasively measure plaque vulnerability and heart function in adults with known or suspected coronary artery disease or type 2 diabetes.

Quick facts

Study typeObservational
Ages18 Years and up
SexAll
Enrollment500 (estimated)
SponsorShanghai Zhongshan Hospital
Academic / other
Locations1 site (Shanghai, Shanghai Municipality)
StatusRecruiting
StartedSeptember 1, 2025
Main results expectedJune 30, 2027
Study endsJune 30, 2030
Registry record updatedMarch 17, 2026
Trial IDNCT07169201 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Adults aged 18 or older with suspected or known coronary artery disease or with type 2 diabetes who can undergo CT angiography and invasive angiography are ideal candidates.

Probably not a fit

Patients who cannot undergo CTA or angiography—such as those with severe renal failure, contrast allergy, pregnancy, or other contraindications—or those at very low cardiovascular risk are unlikely to benefit.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This prospective observational study uses the uCT SiriuX Pro, an ultra-high-temporal-resolution cardiac CT platform, to derive CT-based radial wall strain (CT-RWS), a CT systolic flow perfusion index (CT-SFPR), and dynamic CT ejection fraction (CT-EF) in high-risk patients. CT-RWS will be compared with invasive optical coherence tomography (OCT) plaque features and clinical outcomes to determine diagnostic and prognostic performance. CT-SFPR will be compared with nuclear perfusion imaging to evaluate the hemodynamic relevance of myocardial bridging, and CT-EF will be compared with transthoracic echocardiography to test feasibility and accuracy. The study enrolls adults with suspected or known coronary artery disease or type 2 diabetes who can undergo CTA and angiography and is conducted at Zhongshan Hospital Fudan University in Shanghai.

Why it matters

Potential benefit: If successful, this could provide a noninvasive way to identify vulnerable plaques and functionally significant lesions, potentially reducing the need for invasive imaging and improving patient risk stratification.

How similar studies have gone: Previous angiography-derived RWS studies have linked high RWS to OCT-defined vulnerable plaques and future events, but CT-derived RWS and the combined CT-SFPR/CT-EF approach are largely novel and require validation.

Who can join: the full rules

Show full inclusion / exclusion criteria
Inclusion Criteria:

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

Exclusion Criteria:

* those can not undergo CTA and angiography

Where it's running

  • Zhongshan Hospital Fudan University
    Shanghai, Shanghai Municipality, China
    Recruiting

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How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.