NCT04665817

Diagnostic Accuracy of CCTA-derived Versus AngiogRaphy-dErived QuantitativE Flow Ratio (CAREER) Study

Diagnostic Accuracy of CCTA-derived Versus AngiogRaphy-dErived QuantitativE Flow Ratio Study

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 216 (estimated)
• Sponsor: Fudan University · Academic / Other
• Sex: All
• Age: 35 Years – 85 Years
• Healthy volunteers: Not accepted

Summary

To perform CT-QFR, invasive coronary angiography, FFR, and QFR tests on patients with moderate coronary stenosis after coronary CTA examination. Use FFR as a reference to verify the diagnostic performance of CT-QFR, and compare it with QFR.

Detailed description

This study is a prospective and single-center trial in China.It intends to enroll 216 patients with coronary artery disease whose coronary artery is determined to be 30-90% stenosis after coronary CT scan. CT image data will be imported for CT-QFR detection and undergo coronary angiography within 30 days. Quantitative analysis of coronary angiography (QCA) was performed with the degree of coronary stenosis. FFR and QFR were detected during the operation. Use FFR as a reference standard to verify the diagnostic performance of CT-QFR and QFR. The primary endpoint is the diagnostic accuracy of CT-QFR in identifying hemodynamically significant coronary stenosis with FFR as the reference standard. Major secondary endpoint is the non-inferiority of CT-QFR compared with QFR in the patients without extensively calcified lesions. The completion of the project will provide patients with a practical non-invasive assessment method of coronary heart disease which provides the best treatment strategy.

Conditions

• Coronary Stenosis
• Hemodynamics
• Coronary Artery Disease
• Coronary Computed Tomography Angiography

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	CT-QFR	CT-QFR is a novel method for evaluating the functional significance of coronary stenosis. It is calculated by coronary computed tomographic angiography images.
DIAGNOSTIC_TEST	QFR	QFR is a novel method for evaluating the functional significance of coronary stenosis by calculation of the pressure drop in the vessel based on two. angiographic projections.
DIAGNOSTIC_TEST	FFR	FFR measured by pressure wire is the gold standard for evaluating the functional significance of coronary stenosis.

Timeline

• Start date: 2020-10-01
• Primary completion: 2022-09-30
• Completion: 2022-12-31
• First posted: 2020-12-14
• Last updated: 2022-01-25

Locations

1 site across 1 country: China