Functional Diagnostic Accuracy of Ultrasonic Flow Ratio in Assessment of Coronary Artery Lesions

Coronary Artery Stenosis Clinical Trial

— FUNCTION  

Official title:

Functional Diagnostic Accuracy of Ultrasonic Flow Ratio in Assessment of De Novo Coronary Artery Lesions

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06052670
• Other study ID #: 2023-GSP-GG-4
• Status: Not yet recruiting
• Start date: September 20, 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

Clinical Trial Summary

This is a prospective, single-center study. The primary purpose of this study is to evaluate the sensitivity and specificity of offline computational ultrasonic flow ratio (UFR) 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 408 patients with 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 coronary artery stenosis will be analyzed.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 408
• 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 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
• IVUS pullback not covering the entire lesion
• Severe myocardial bridge in the interrogated vessel

Related Conditions & MeSH terms

• Coronary Artery Stenosis
• Coronary Stenosis

Intervention

Diagnostic Test:
• fractional flow reserve (FFR); ultrasonic flow ratio (UFR); intravascular ultrasound (IVUS)
pressure wire-based fractional flow reserve (FFR); intravascular ultrasound (IVUS)-based ultrasonic flow ratio (UFR)

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
China National Center for Cardiovascular Diseases

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Sensitivity and specificity of UFR in predicting functionally significant coronary stenosis at the patient level, using FFR as the reference standard	Sensitivity is defined as the proportion of UFR = 0.80 in patients with hemodynamically-significant stenosis as measured by FFR (FFR = 0.80); specificity is defined as the proportion of UFR > 0.80 in patients without hemodynamically-significant stenosis as measured by FFR (FFR > 0.80).	Immediately after the procedure
Secondary	Sensitivity and specificity of UFR in predicting functionally significant coronary stenosis at the vessel level, 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 > 0.8).	Immediately after the procedure
Secondary	Diagnostic accuracy of UFR in predicting functionally significant coronary stenosis at the patient level, using FFR as the reference standard	Diagnostic accuracy is defined as UFFR (=0.80 or >0.80) to identify hemodynamically-significant coronary stenosis with FFR (=0.8 or >0.8) as the reference standard.	Immediately after the procedure
Secondary	The AUC of UFR for coronary stenosis with FFR as the gold standard	AUC is defined as the area under the receiver-operating characteristic curve	Immediately after the procedure