Clinical trial NCT06053944: Functional Diagnostic Accuracy of Ultrasonic Flow Ratio in Assessment of Left Main Coronary Artery Stenosis
Official title: Functional Diagnostic Accuracy of Ultrasonic Flow Ratio in Assessment of Left Main Coronary Artery Stenosis
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Left Main Coronary Artery Disease
Keywords: intravascular ultrasound
ultrasonic flow ratio
fractional flow reserve
Lead sponsor: China National Center for Cardiovascular Diseases
Sponsor class: OTHER_GOV
First posted: 2023-09-26
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

Brief 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.


Eligibility criteria: 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

Primary outcomes:
measure: Diagnostic accuracy of UFR in predicting functionally significant left main coronary stenosis, using FFR as the reference standard
timeFrame: Immediately after the procedure
measure: Sensitivity and specificity of UFR in predicting functionally significant left main coronary stenosis, using FFR as the reference standard
timeFrame: Immediately after the procedure
Secondary outcomes:
measure: 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
timeFrame: Immediately after the procedure
measure: The AUC of UFR for left main coronary stenosis with FFR as the gold standard
timeFrame: Immediately after the procedure
Other outcomes:
Locations:
city: Beijing
country: China
facility: Fuwai Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College
state: Select A State
Study officials:
affiliation: Fuwai Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College
name: Jie Qian
role: PRINCIPAL_INVESTIGATOR
References: