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

NCT06949150 | Recruiting DMC

• 1 other identifier: ZS-CoroFusion
• Study Type: observational
• Target: 2,000
• Locations: 1 country
• Sites: 1

Brief 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). 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.

Conditions

Coronary Arterial Disease (CAD)

Keywords

coronary artery disease, CT angiography, CT perfusion

Outcome Measures

Primary Outcomes (5)

• Major Adverse Cardiovascular Events (MACE)

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

  From enrollment to the follow-up of 5 year

• 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%).

  30 days

• Agreement Between CT-FFR and CTP Perfusion Metrics

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

  30 days

• 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.

  From enrollment to the follow-up of 5 year

• 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.

  From enrollment to the follow-up of 5 year

Secondary Outcomes (4)

• Association Between Perfusion Recovery and Symptom Relief

  From enrollment to the follow-up of 1 year

• Dynamic Perfusion Changes in Microvascular Dysfunction

  30 days

• Sex-Specific Differences in Perfusion-Plaque Relationships

  30 days

• Impact of Severe Calcification on CTP Diagnostic Accuracy

  30 days

Study Arms (2)

Conservative group

Patients do not undergo invasive coronary angiography (ICA) and receive medical treatment, lifestyle interventions, or additional tests instead.

Other: Medical therapy

ICA group

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

Diagnostic Test: coronary angiography

Interventions

coronary angiography DIAGNOSTIC_TEST

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

ICA group

Medical therapy OTHER

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

Conservative group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients with an indication for CTP

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Shanghai Zhongshan Hospital: lead

Study Sites (1)

Zhongshan Hospital Fudan University

Shanghai, Shanghai Municipality, 200030, China

RECRUITING

MeSH Terms

Conditions

Coronary Artery Disease

Interventions

Coronary Angiography; Nutrition Therapy

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases

Intervention Hierarchy (Ancestors)

Cardiac Imaging Techniques; Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis; Angiography; Radiography; Diagnostic Techniques, Cardiovascular; Heart Function Tests; Therapeutics

Central Study Contacts

Wei Gao, PHD

CONTACT

+8613661959824; gao.wei1@zs-hospital.sh.cn

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 5 Years
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 9, 2025
• First Posted: April 29, 2025
• Study Start: January 1, 2025
• Primary Completion (Estimated): December 31, 2029
• Study Completion (Estimated): December 31, 2034
• Last Updated: April 29, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)