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

China National Center for Cardiovascular Diseases408 enrolled

Overview

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.

Study Type

OBSERVATIONAL

Enrollment

408

Conditions

Coronary Artery Stenosis

Interventions

fractional flow reserve (FFR); ultrasonic flow ratio (UFR); intravascular ultrasound (IVUS)DIAGNOSTIC_TEST

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

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).

Time frame: Immediately after the procedure

Secondary Outcomes

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).

Time frame: Immediately after the procedure

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.

Time frame: Immediately after the procedure

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

Time frame: Immediately after the procedure

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

Overview

Conditions

Interventions

Eligibility

Outcomes

Primary Outcomes

Secondary Outcomes

Central Contacts