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Coronary Arterial Disease (CAD)NCT06949150

Combined Coronary CT Angiography and CT Perfusion in Coronary Artery Disease (CoroFusion)

An observational study of Coronary Arterial Disease (CAD), run by Shanghai Zhongshan Hospital at 1 site in China.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

Coronary computed tomography angiography (CTA) provides high-resolution imaging of coronary artery disease (CAD), revealing stenosis, plaque characteristics, and hemodynamic markers like CT-derived fractional flow reserve (CT-FFR), axial plaque stress (APS), and wall shear stress (WSS). Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Coronary Arterial Disease (CAD)
What is being tested?
coronary angiography and Medical therapy
How many people
2,000 participants
Where
1 siteChina
Study dates
1 Jan 2025to 31 Dec 2034
How long will I take part?
5 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: Patients with an indication for CTP

Who may be able to join

  • Patients with an indication for CTP. Qualified patients who have signed a written informed consent form.

Who cannot join

  • Left ventricular ejection fraction < 35%;
  • Acute ST-elevation myocardial infarction within 3 months or previous coronary artery bypass graft surgery;
  • Planned coronary artery bypass graft surgery after diagnostic angiography;
  • Poor quality of CTA/CTP or other reasons by core lab that are unsuitable for plaque, physiological or fat analysis;
  • Contraindications for CT perfusion or coronary angiography;
  • Coexisting conditions such as pregnancy, cancer, severe valvular heart disease, or liver/kidney dysfunction;
  • Other diseases with a life expectancy of less than one year;
  • Inability to sign informed consent or, in the researcher's judgment, poor compliance, making it unlikely the patient can complete the study as required.

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
  • Zhongshan Hospital Fudan University

    Shanghai, Shanghai Municipality, 200030

    Wei Gao, PHD, 13661959824, gao.wei1@zs-hospital.sh.cn

    Recruiting

Other trials in China

About this study

Official title: Combined Coronary CT Angiography and CT Perfusion in Coronary Artery Disease: Integrating Plaque Morphology, Hemodynamics, and Perfusion for Precision Management

Coronary computed tomography angiography (CTA) provides high-resolution imaging of coronary artery disease (CAD), revealing stenosis, plaque characteristics, and hemodynamic markers like CT-derived fractional flow reserve (CT-FFR), axial plaque stress (APS), and wall shear stress (WSS). However, CTA alone has limitations in evaluating the functional significance of lesions, especially in cases with borderline stenosis, severe calcification, or coronary microvascular dysfunction (CMD). CT myocardial perfusion (CTP) complements CTA by directly assessing myocardial blood flow (MBF) and perfusion reserve (MPR), enhancing diagnostic accuracy. Despite its promise, integrating CTA and CTP for comprehensive CAD assessment remains a challenge.

Key gaps include the lack of long-term evidence on combined CTA/CTP findings, particularly in incorporating plaque markers with perfusion deficits. Standardizing ischemic thresholds and validating automated CTP analysis tools remain ongoing challenges. CTP also improves specificity in cases where CTA may overestimate ischemic burden and detects microvascular dysfunction, especially in patients with ischemia and no obstructive CAD (INOCA). Quantitative parameters like MBF have been linked to major adverse cardiovascular events (MACE), but issues with protocol variability and cost-effectiveness persist.

This study, a real-world, single-center observational cohort, evaluates the clinical utility of integrated CTA/CTP imaging in CAD management. It will assess diagnostic synergy, impact on clinical decisions, and prognostic value in predicting 5-year MACE. AI-driven imaging analysis will quantify plaque features and myocardial perfusion defects, integrating multimodal parameters to generate individualized ischemia risk scores. The goal is to refine non-invasive diagnostic pathways and improve CAD management strategies.

Read the detailed description

Coronary computed tomography angiography (CTA) has transformed the non-invasive assessment of coronary artery disease (CAD) by providing high-resolution visualization of coronary stenosis, plaque characteristics, and emerging hemodynamic parameters such as CT-derived fractional flow reserve (CT-FFR), axial plaque stress (APS), and wall shear stress (WSS). Adverse plaque features, including low-attenuation plaque, napkin-ring sign, positive remodeling, and spotty calcification, have been associated with increased ischemic risk and adverse cardiovascular events. However, CTA alone has inherent limitations in evaluating the functional significance of coronary lesions, particularly in cases of borderline stenosis, diffuse atherosclerosis, severe calcification, and coronary microvascular dysfunction (CMD). CT myocardial perfusion (CTP) serves as a functional complement to CTA by directly assessing myocardial blood flow (MBF), myocardial perfusion reserve (MPR), and time-to-peak (TTP), thereby enhancing diagnostic accuracy and risk stratification in CAD. Despite promising results from previous trials, significant gaps remain in integrating CTA and CTP for comprehensive CAD assessment.

One of the critical gaps is the limited evidence regarding the long-term prognostic implications of combined CTA/CTP findings, particularly when incorporating plaque vulnerability markers (e.g., lipid-rich necrotic core, pericoronary fat attenuation index) with perfusion deficits. Additionally, the quantification of CTP perfusion defects remains an area of active investigation, with ongoing challenges in standardizing ischemic thresholds, optimizing dynamic versus static protocols, and validating automated analysis tools across diverse populations. Furthermore, insufficient data exist on how an integrated anatomical-functional approach influences clinical decision-making, including revascularization strategies, medical therapy optimization, and long-term outcomes in high-risk subgroups such as patients with diabetes, CMD, in-stent restenosis, and severe coronary calcification.

CTP provides unique diagnostic advantages by improving specificity in cases where CTA may overestimate ischemic burden, particularly in moderate stenoses without hemodynamic significance. Moreover, CTP has proven valuable in detecting microvascular dysfunction by identifying impaired MPR in patients with ischemia and no obstructive CAD (INOCA), a population often misclassified by CTA alone. Quantitative perfusion parameters, such as MBF thresholds (<180 mL/100mL/min), have been independently associated with major adverse cardiovascular events (MACE). However, unresolved issues persist, including protocol variability, limited real-world validation of automated perfusion analysis tools, and unclear cost-effectiveness in routine clinical workflows.

This study is a real-world, single-center observational cohort study designed to evaluate the clinical utility of integrated CTA/CTP imaging in CAD management. All treatment decisions will be made jointly by cardiologists and patients based on imaging results and clinical considerations. Patients may undergo medical therapy alone, invasive coronary angiography (ICA) with percutaneous coronary intervention (PCI) when necessary, or additional non-invasive testing such as cardiac magnetic resonance (CMR) or single-photon emission computed tomography (SPECT) for further functional assessment. Our research team will prospectively track the full clinical trajectory of these patients, ensuring comprehensive data collection on diagnostic pathways, therapeutic interventions, and long-term outcomes. At appropriate time points, patients will be stratified into relevant subgroups for detailed analysis.

The primary objectives of this study are threefold: (1) to evaluate the diagnostic synergy of combining CTA-derived stenosis severity, plaque morphology, and hemodynamic markers with CTP-derived ischemic parameters against invasive reference standards such as FFR and coronary flow reserve (CFR); (2) to assess the impact of CTA/CTP-guided strategies on clinical decision-making, including revascularization rates, medical therapy adjustments, and lifestyle interventions; and (3) to determine the prognostic value of combined imaging biomarkers in predicting 5-year MACE, with a focus on sex-specific and diabetes-specific thresholds for ischemia detection.

In addition, this study will perform subgroup analyses to stratify outcomes in high-risk populations, including patients with diabetes and CMD, post-percutaneous coronary intervention (PCI) cohorts with in-stent restenosis or peri-stent plaque progression, and individuals with severe coronary calcification (Agatston score >400), where CTA interpretation remains challenging. Methodologically, the study will incorporate AI-driven imaging analysis for both CTA and CTP. Advanced deep learning algorithms will be used to automatically quantify CTA plaque features, including lipid core volume, fibrous cap thickness, and pericoronary adipose tissue attenuation, improving risk stratification beyond conventional stenosis-based assessments. AI-based CTP analysis will enable automated segmentation and quantification of myocardial perfusion defects, standardizing ischemia thresholds and reducing interobserver variability. Furthermore, machine learning models will integrate multimodal imaging parameters-stenosis severity, plaque vulnerability markers, hemodynamic stress metrics (APS, WSS), and perfusion indices-to generate individualized ischemia risk scores, aiding in personalized treatment decision-making. Advanced hemodynamic modeling using finite element analysis will be employed for CT-FFR and APS computation, validated against invasive pressure wire measurements.

By addressing existing limitations in CAD imaging, this study aims to establish standardized criteria for interpreting combined CTA/CTP findings, provide robust evidence for CTP-guided risk stratification in understudied populations, define the cost-benefit profile of multimodal imaging, and generate a large-scale imaging registry to support future research in precision cardiovascular medicine. The findings from this study are expected to refine non-invasive diagnostic pathways and contribute to the development of personalized, evidence-based strategies for CAD management.

Being tested
coronary angiography, Medical therapy
Keywords
coronary artery disease, CT angiography, CT perfusion
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.

  • coronary angiographyDiagnostic test

    Invasive coronary angiography (ICA), with or without percutaneous coronary intervention (PCI), intravascular ultrasound (IVUS), optical coherence tomography (OCT), or fractional flow reserve (FFR).

  • Medical therapyOther

    Patients do not undergo invasive coronary angiography (ICA), recieving medical treatment, lifestyle intervention or further test

Study groups in NCT06949150
Study groupRoleWhat they receive
Conservative groupPatients do not undergo invasive coronary angiography (ICA) and receive medical treatment, lifestyle interventions, or additional tests instead.
Receives: Other: Medical therapy
ICA groupPatients undergo invasive coronary angiography (ICA), with or without percutaneous coronary intervention (PCI), intravascular ultrasound (IVUS), optical coherence tomography (OCT), or fractional flow reserve (FFR).
Receives: Diagnostic Test: coronary angiography

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Major Adverse Cardiovascular Events (MACE)

    Composite endpoint including cardiovascular death, non-fatal myocardial infarction (MI), hospitalization for unstable angina, and unplanned coronary revascularization.

    Measured: From enrollment to the follow-up of 5 year

  2. Diagnostic Accuracy of Combined CTA/CTP vs. Invasive FFR/CFR

    Sensitivity, specificity, positive predictive value (PPV), negative predictive value (NPV), and area under the ROC curve (AUC) for detecting hemodynamically significant lesions (FFR ≤0.80 or CFR <2.0 or stenosis >90%).

    Measured: 30 days

  3. Agreement Between CT-FFR and CTP Perfusion Metrics

    Correlation between CT-FFR values and CTP-derived myocardial blood flow (MBF) or perfusion defect size.

    Measured: 30 days

  4. Predictive Power of Combined Imaging Biomarkers for MACE

    Hazard ratios (HRs) for MACE associated with:High-risk plaque (≥2 adverse features: low-attenuation plaque, positive remodeling, napkin-ring sign, spotty calcification). Perfusion deficit (MBF <150 mL/100mL/min or MPR <1.8). Combined high-risk plaque + perfusion deficit.

    Measured: From enrollment to the follow-up of 5 year

  5. Prognostic Utility of Peri-Coronary Fat Attenuation Index (FAI)

    Association between elevated FAI (>-70 HU) around stenotic lesions and MACE, adjusted for plaque burden and CTP parameters.

    Measured: From enrollment to the follow-up of 5 year

Secondary outcomes (4)
  1. Association Between Perfusion Recovery and Symptom Relief

    Percentage of patients with ≥50% reduction in angina episodes linked to normalized MBF (≥200 mL/100mL/min) or MPR (≥2.2) on follow-up CTP.

    Measured: From enrollment to the follow-up of 1 year

  2. Dynamic Perfusion Changes in Microvascular Dysfunction

    Differences in stress/rest MBF ratios between patients with vs. without coronary microvascular dysfunction (CMD), validated by invasive coronary flow reserve (CFR <2.0).

    Measured: 30 days

  3. Sex-Specific Differences in Perfusion-Plaque Relationships

    Stratified analysis of plaque-perfusion correlations in women (e.g., higher prevalence of CMD) vs. men.

    Measured: 30 days

  4. Impact of Severe Calcification on CTP Diagnostic Accuracy

    Sensitivity/specificity of CTP for detecting ischemia in lesions with Agatston score >400, compared to invasive FFR.

    Measured: 30 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted29 Apr 2025
  2. Study start1 Jan 2025
  3. Primary completion31 Dec 2029 (estimated)
  4. Study completion31 Dec 2034 (estimated)

Resources

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
2,000 participants (estimated)
Target duration
5 Years
IDs, dates and publications
ClinicalTrials.gov ID
NCT06949150
Sponsor's protocol ID
ZS-CoroFusion
Status last verified
Feb 2025
First submitted
9 Feb 2025
Last updated
29 Apr 2025
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

An observational study of Coronary Arterial Disease (CAD), 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 8 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 29 Apr 2025. 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?

Contact Wei Gao, PHD (+8613661959824, gao.wei1@zs-hospital.sh.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Major Adverse Cardiovascular Events (MACE) (time frame: From enrollment to the follow-up of 5 year). The study lists 5 primary outcomes in all. 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 29 Apr 2025.

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