Functional Diagnostic Accuracy of Ultrasonic Flow Ratio in Assessment of Left Main Coronary Artery Stenosis (FUNCTION II)

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.

Study Overview

• Status: Recruiting
• Conditions: Left Main Coronary Artery Disease
• Intervention / Treatment: Diagnostic test: fractional flow reserve (FFR); ultrasonic flow ratio (UFR); intravascular ultrasound (IVUS)

• Study Type: Observational
• Enrollment (Estimated): 120

Contacts and Locations

• Study Contact: Name: Jie Qian, MD; Phone Number: +8613601396650; Email: qianjfw@163.com
• Study Contact Backup: Name: Cheng Yang, MD; Phone Number: +8619801116690; Email: yangcheng_fw@163.com

Study Locations

• China
  • Select A State
    • Beijing, Select A State, China, 100037
      • Recruiting
      • Fuwai Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College
      • Contact: Jie Qian; Email: qianjfw@163.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

Patients ≥ 18 years of age who will be admitted for coronary angiography and had an indication for FFR measurement at the Fuwai Hospital, Beijing, China, due to stable angina or unstable angina will be consecutively enrolled.

Description

Inclusion Criteria:

• Stable angina pectoris, unstable angina pectoris, or after the acute phase of myocardial infarction
• Age ≥18 years
• Written informed consent
• Intermediated left main coronary lesions (diameter stenosis of 30%-80% by visual estimation from coronary angiography)

Exclusion Criteria:

• Ineligible for diagnostic IVUS or FFR examination
• Prior coronary artery bypass grafting of the interrogated vessels
• Myocardial infarction within 72 h of coronary angiography
• Severe heart failure
• Serum creatinine levels >150 umol/L, or glomerular filtration rates <45 ml/ kg/1.73 m2
• Allergy to the contrast agent or adenosine
• Life expectancy < 2 years
• Proximal LAD diffuse lesions (diameter stenosis > 50%)
• IVUS pullback not covering the entire lesion
• Severe myocardial bridge in the interrogated vessel

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Diagnostic accuracy of UFR in predicting functionally significant left main coronary stenosis, using FFR as the reference standard	Diagnostic accuracy is defined as UFFR (≤0.80 or >0.80) to identify hemodynamically-significant left main coronary stenosis with FFR (≤0.80 or >0.80) as the reference standard.	Immediately after the procedure
Sensitivity and specificity of UFR in predicting functionally significant left main coronary stenosis, using FFR as the reference standard	Sensitivity is defined as the proportion of UFR ≤ 0.80 in vessels with hemodynamically-significant stenosis as measured by FFR (FFR ≤ 0.80); specificity is defined as the proportion of UFR > 0.80 in vessels without hemodynamically-significant stenosis as measured by FFR (FFR > 0.80).	Immediately after the procedure

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Comparison of sensitivity and specificity of UFR and IVUS-derived minimal lumen area (MLA) in predicting functionally significant left main coronary stenosis, using FFR as the reference standard	Sensitivity is defined as the proportion of UFR ≤ 0.80 in vessels with hemodynamically-significant stenosis as measured by FFR (FFR ≤ 0.80); specificity is defined as the proportion of UFR > 0.80 in vessels without hemodynamically-significant stenosis as measured by FFR (FFR > 0.80).	Immediately after the procedure
The AUC of UFR for left main coronary stenosis with FFR as the gold standard	AUC is defined as the area under the receiver-operating characteristic curve.	Immediately after the procedure

Collaborators and Investigators

• Sponsor: China National Center for Cardiovascular Diseases
• Investigators: Principal Investigator: Jie Qian, Fuwai Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College

Study record dates

Study Major Dates

• Study Start (Actual): October 18, 2023
• Primary Completion (Estimated): December 31, 2024
• Study Completion (Estimated): December 31, 2024

Study Registration Dates

• First Submitted: September 17, 2023
• First Submitted That Met QC Criteria: September 22, 2023
• First Posted (Actual): September 26, 2023

Study Record Updates

• Last Update Posted (Actual): January 22, 2024
• Last Update Submitted That Met QC Criteria: January 19, 2024
• Last Verified: September 1, 2023

More Information

Terms related to this study

• Keywords: intravascular ultrasound; fractional flow reserve; ultrasonic flow ratio
• Additional Relevant MeSH Terms: Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Coronary Disease; Coronary Artery Disease; Coronary Stenosis
• Other Study ID Numbers: 2022-12M-C&T-B-043

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No