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

Recruiting now

Conditions studied: Coronary Arterial Disease (CAD)

In brief

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.

Key facts

Study ID: NCT06949150
Run by: Shanghai Zhongshan Hospital
People needed: 2000
Starts: 2025-01-01
Expected to finish: 2034-12-31
Last updated by the study team: 2025-04-29

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

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.

Where it is running

Zhongshan Hospital Fudan University — Shanghai, Shanghai Municipality, China (enrolling)

Full record on ClinicalTrials.gov

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