NCT06053944

Functional Diagnostic Accuracy of Ultrasonic Flow Ratio in Assessment of Left Main Coronary Artery Stenosis

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 120 (estimated)
• Sponsor: China National Center for Cardiovascular Diseases · Other Government
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is a prospective, observational, single-center study. The main purpose of this study is to evaluate the diagnostic accuracy of offline computational ultrasonic flow ratio (UFR) in predicting functionally significant left main (LM) coronary stenosis with conventional pressure wire-based fractional flow reserve (FFR) as the standard reference. The study will be conducted in Fuwai Hospital, and a total of 120 patients with intermediated left main coronary vessel diameter stenosis ≥30% and ≤80% are planned to be recruited. Participants who meet the inclusion criteria and do not meet the exclusion criteria will undergo intravascular ultrasound (IVUS) followed by FFR examination. IVUS imaging will be sent to an independent core laboratory for UFR calculation. UFR analyses were performed offline in a blinded fashion without awareness of FFR measurement. Using FFR≤0.80 as the gold standard, the sensitivity and specificity of UFR in the functional significance of left main coronary artery stenosis will be analyzed.

Conditions

• Left Main Coronary Artery Disease

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	fractional flow reserve (FFR); ultrasonic flow ratio (UFR); intravascular ultrasound (IVUS)	UFR is a novel IVUS-derived modality for fast computation of FFR without pressure wires and adenosine.

Timeline

• Start date: 2023-10-18
• Primary completion: 2024-12-31
• Completion: 2024-12-31
• First posted: 2023-09-26
• Last updated: 2024-01-22

Locations

1 site across 1 country: China