Clinical trial NCT06822894: Clinical Implications of Three-vessel Ultrasonic Flow Ratio Measurement in Patients with Coronary Artery Disease
Official title: Clinical Implications of Three-vessel Ultrasonic Flow Ratio Measurement in Patients with Coronary Artery Disease
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Coronary Artery Disease (CAD)
Lead sponsor: China National Center for Cardiovascular Diseases
Sponsor class: OTHER_GOV
First posted: 2025-02-12
Enrollment: 495
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 aged 18 years or older admitted to Fuwai Hospital (Beijing, China) for coronary angiography and demonstrating angiographically confirmed ≥30% stenosis in all three major coronary arteries through visual assessment, will be consecutively enrolled in the study.

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 three 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 at least 495 patients with all the three coronary vessel diameter stenoses ≥30% 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 all the three coronary artery stenoses 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; Angiographically confirmed ≥30% diameter stenosis in all three major epicardial coronary arteries (left anterior descending, left circumflex, and right coronary artery); Patients with clinical indications for revascularization who have successfully completed percutaneous coronary intervention (PCI) prior to study enrollment.

Exclusion Criteria:

Ineligible for diagnostic IVUS examination; Prior coronary artery bypass grafting (CABG); Myocardial infarction within 72 hours 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; Severe coronary artery disease requiring CABG identified during angiography; Extreme vascular tortuosity precluding IVUS catheter advancement; Suboptimal IVUS image quality impairing quantitative analysis.

Primary outcomes:
measure: Major adverse cardiac events (MACE) at 1 year
timeFrame: 1 year after the procedure
Secondary outcomes:
measure: Major adverse cardiac events (MACE) at 1 month
timeFrame: 1 month after the procedure
measure: Major adverse cardiac events (MACE) at 6 months
timeFrame: 6 months after the procedure
Other outcomes:
Locations:
city: Beijing
country: China
facility: Fuwai Hospital,Chinese Academy of Medical Sciences and Peking Union Medical College
Study officials:
References: