High-resolution coronary CT for plaque biomechanics and heart function
A High-Temporal Resolution CT Platform for Imaging and Functional Evaluation of Heart
Shanghai Zhongshan Hospital · NCT07169201
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 type | Observational |
|---|---|
| Enrollment | 500 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Shanghai Zhongshan Hospital (other) |
| Locations | 1 site (Shanghai, Shanghai Municipality) |
| Trial ID | NCT07169201 on ClinicalTrials.gov |
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.
Who should consider this trial
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.
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.
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 performed: 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.
Eligibility criteria
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 this trial is running
Shanghai, Shanghai Municipality
- Zhongshan Hospital Fudan University — Shanghai, Shanghai Municipality, China (RECRUITING)
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Coronary Artery Disease