Coronary Artery DiseaseNCT07169201
High-Resolution CT for Heart
An observational study of Coronary Artery Disease, run by Shanghai Zhongshan Hospital at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Coronary Artery Disease
- What is being tested?
- Angiography based RWS and OCT based plaque characteristcis
- How many people
- 500 participants
- Where
- 1 siteChina
- Study dates
- 1 Sep 2025to 30 Jun 2030
- How long will I take part?
- 3 Years
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: In this study, we consecutively enrolled patients who were either suspected or diagnosed with coronary artery disease (CAD) in the outpatient setting, as well as those with diabetes presenting with atypical symptoms. Patients were eligible for inclusion if they were willing to undergo coronary CT angiography (CTA) followed by invasive coronary angiography. Major exclusion criteria included contrast agent allergy, impaired renal function, a history of coronary artery bypass grafting, and any other condition deemed unsuitable for CTA or invasive coronary angiography.
Who may be able to join
- Adults ≥18 years with suspected or known CAD or with type 2 diabetes
Who cannot join
- those can not undergo CTA and angiography
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Zhongshan Hospital Fudan University
Shanghai, Shanghai Municipality, 200030
Wei Gao, 13661959824, gao.wei1@zs-hospital.sh.cn
About this study
Official title: A High-Temporal Resolution CT Platform for Imaging and Functional Evaluation of 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.
Read the detailed description
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.
- Conditions
- Coronary Artery Disease
- Being tested
- Angiography based RWS and OCT based plaque characteristcis
- Medical subject headings
- Coronary Artery Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Angiography based RWS and OCT based plaque characteristcisDiagnostic test
Angiography based RWS and OCT based plaque characteristcis
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Diagnostic Test: Angiography based RWS and OCT based plaque characteristcis | |
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
correlation between CT-RWS and Angiography-derived RWS/OCT-detected vulnerable plaque features
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.
Measured: Perioperative/Periprocedural
Secondary outcomes (1)
CT perfsusion and myocardial bridging
To evaluate a novel CT-derived Systolic Flow Perfusion Ratio (CT-SFPR) for myocardial bridging lesions, by comparison with ischemia detected on SPECT.
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Sep 2025
- Study start1 Sep 2025
- Primary completion30 Jun 2027 (estimated)
- Study completion30 Jun 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Coronary Artery DiseaseStudies of the same condition, open and under way.
- More trials run by Shanghai Zhongshan HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 500 participants (estimated)
- Target duration
- 3 Years
Sponsor and investigators
- Lead sponsor
- Shanghai Zhongshan Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07169201
- Sponsor's protocol ID
- HiTe-CT
- Status last verified
- Aug 2025
- First submitted
- 2 Aug 2025
- Last updated
- 17 Mar 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A High-Temporal Resolution CT Platform for Imaging and Functional Evaluation of Heart
- ClinicalTrials.gov ID
- NCT07169201
- Acronym / sponsor ID
- HiTe-CT
- Conditions
- Coronary Artery Disease
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- Shanghai Zhongshan HospitalUniversity, hospital or other
- Study start
- 1 Sep 2025 (actual)
- Primary completion
- 30 Jun 2027 (estimated)
- Study completion
- 30 Jun 2030 (estimated)
- First posted
- 11 Sep 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 3 Years
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Cohort for CT-RWS | – | Diagnostic Test: Angiography based RWS and OCT based plaque characteristcisThis 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- In this study, we consecutively enrolled patients who were either suspected or diagnosed with coronary artery disease (CAD) in the outpatient setting, as well as those with diabetes presenting with atypical symptoms. Patients were eligible for inclusion if they were willing to undergo coronary CT angiography (CTA) followed by invasive coronary angiography. Major exclusion criteria included contrast agent allergy, impaired renal function, a history of coronary artery bypass grafting, and any other condition deemed unsuitable for CTA or invasive coronary angiography.
Key inclusion criteria (1 listed)
- Adults ≥18 years with suspected or known CAD or with type 2 diabetes
Key exclusion criteria (1 listed)
- those can not undergo CTA and angiography
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Angiography based RWS and OCT based plaque characteristcisAngiography based RWS and OCT based plaque characteristcis | Diagnostic test | Cohort for CT-RWS |
Primary outcome
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.
1 secondary outcome
CT perfsusion and myocardial bridging
Time frame: Baseline
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Mar 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Coronary Artery Disease, run by Shanghai Zhongshan Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 17 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
correlation between CT-RWS and Angiography-derived RWS/OCT-detected vulnerable plaque features (time frame: Perioperative/Periprocedural). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Mar 2026.