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RECRUITING
NCT06949150

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

Sponsor: Shanghai Zhongshan Hospital

View on ClinicalTrials.gov

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.

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

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

OBSERVATIONAL

Enrollment

2000

Start Date

2025-01-01

Completion Date

2034-12-31

Last Updated

2025-04-29

Healthy Volunteers

No

Interventions

DIAGNOSTIC_TEST

coronary angiography

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

OTHER

Medical therapy

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

Locations (1)

Zhongshan Hospital Fudan University

Shanghai, Shanghai Municipality, China