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

Left Main Coronary Artery Disease Clinical Trial

— FUNCTION II  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06053944
• Other study ID #: 2022-12M-C&T-B-043
• Status: Recruiting
• Start date: October 18, 2023
• Est. completion date: December 31, 2024

Study information

• Verified date: September 2023
• Source: China National Center for Cardiovascular Diseases
• Contact: Jie Qian, MD
• Phone: +8613601396650
• Email: qianjfw[@]163.com
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 120
• Est. completion date: December 31, 2024
• Est. primary completion date: December 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Coronary Artery Disease
• Coronary Stenosis
• Left Main Coronary Artery Disease

Intervention

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.

Locations

Country	Name	City	State
China	Fuwai Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College	Beijing	Select A State

Sponsors (1)

Lead Sponsor	Collaborator
China National Center for Cardiovascular Diseases

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	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
Secondary	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