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NCT Number: NCT07169201

High-Resolution CT for Heart

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Zhongshan Hospital Fudan University

Shanghai, Shanghai Municipality, 200030, China

Location status: Recruiting

Location contact

About this study

Vulnerable coronary plaques remain a major cause of adverse cardiac events, including myocardial infarction and cardiac death, even in lesions that are not flow-limiting by conventional assessment. Invasive imaging modalities such as optical coherence tomography (OCT) have enabled identification of high-risk plaque features, including thin-cap fibroatheroma (TCFA), large lipid pools, and high lipid-to-cap ratio (LCR), which are linked to plaque rupture and clinical instability. However, the widespread use of OCT is limited by cost, technical demands, and the need for invasive catheterization.

Radial wall strain (RWS) has emerged as a novel imaging biomarker reflecting local plaque biomechanics. Studies based on angiography-derived RWS, such as those by Wang et al. (JACC Cardiovasc Interv 2025) and Hong et al. (EuroIntervention 2023), have shown that high RWS is significantly associated with OCT-defined vulnerable plaque features and predictive of future cardiovascular events, particularly in high-risk populations. Despite this promise, angiographic RWS still requires invasive procedures.

To overcome this limitation, the investigators have developed a non-invasive imaging platform: the uCT SiriuX Pro, an advanced cardiac CT scanner designed by United Imaging Healthcare. With a leading gantry rotation speed of 0.229 seconds, this system enables ultra-high temporal resolution, supporting high-fidelity cardiac cine imaging, spectral imaging, and integrated perfusion-angiography acquisition. These capabilities allow for the first-time derivation of CT-based radial wall strain (CT-RWS) from coronary CT angiography (CTA), offering a novel, fully non-invasive surrogate for assessing plaque biomechanics. This technology has not been previously documented in the literature.

In addition to evaluating plaque vulnerability, the study also aims to assess myocardial bridging (MB), a congenital anomaly often regarded as benign but increasingly linked to ischemia and adverse outcomes. Using high-temporal-resolution CT, the investigators propose to derive a new index-the systolic flow perfusion ratio (CT-SFPR)-to quantify dynamic coronary compression and its hemodynamic impact. The diagnostic relevance of CT-SFPR will be compared with established perfusion deficits identified on nuclear imaging.

Furthermore, the advanced temporal resolution of uCT SiriuX Pro enables dynamic volumetric analysis of left ventricular function. This study will also evaluate CTA-derived ejection fraction (CT-EF) in comparison with echocardiography to validate its feasibility and accuracy for non-invasive cardiac function assessment.

This prospective observational registry will enroll high-risk patients with suspected or known coronary artery disease. It aims to systematically validate CT-RWS, CT-SFPR, and CT-EF against invasive and functional imaging benchmarks and to assess their prognostic significance during clinical follow-up.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • those can not undergo CTA and angiography

Treatment and study plan

Angiography based RWS and OCT based plaque characteristcis

Diagnostic Test

Angiography based RWS and OCT based plaque characteristcis

Primary outcomes

  1. correlation between CT-RWS and Angiography-derived RWS/OCT-detected vulnerable plaque features

    Time frame: Perioperative/Periprocedural

    We will measure the RWS derived from coronary CT angiography (CT-RWS). After patients undergo coronary angiography and OCT examinations, we will also measure the angiography-derived RWS, both expressed as percentages. Correlation analyses will be performed to investigate the association between CT-RWS and angiography-derived RWS. In addition, OCT plaque characteristics, including thin-cap fibroatheroma, lipidic plaque burden, and lipid-to-cap ratio, will be assessed. Correlation analyses will be conducted to explore the relationships between CT-RWS and these OCT-derived plaque characteristics.

Secondary outcomes

  1. CT perfsusion and myocardial bridging

    Time frame: Baseline

    To evaluate a novel CT-derived Systolic Flow Perfusion Ratio (CT-SFPR) for myocardial bridging lesions, by comparison with ischemia detected on SPECT.

Other outcomes

  1. prognostic value of CT-RWS

    Time frame: from enrollment to 3-year follow up

    To assess the prognostic value of CT-RWS for major adverse cardiovascular events (MACE) during 3-year follow-up.

Sponsors and collaborators

Lead sponsor

Shanghai Zhongshan Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2027
Study completion
2030
First posted
Sep 11, 2025
Registry last updated
Mar 17, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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