Three-vessel ultrasonic flow ratio to predict one-year heart risk in people with coronary artery disease

Clinical Implications of Three-vessel Ultrasonic Flow Ratio Measurement in Patients With Coronary Artery Disease

This will test if measuring the ultrasonic flow ratio in all three coronary arteries can help predict one-year risk of major heart problems in adults with coronary artery disease who have at least 30% narrowing in each artery.

Quick facts

• Study type: Observational
• Enrollment: 494 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: China National Center for Cardiovascular Diseases (Government)
• Locations: 1 site (Beijing)
• Trial ID: NCT06822894 on ClinicalTrials.gov

What this trial studies

This is a prospective, observational single-center study enrolling at least 494 adults with angiographic ≥30% stenosis in all three major epicardial coronary arteries at Fuwai Hospital. Eligible participants will undergo intravascular ultrasound (IVUS) and the IVUS images will be sent to an independent core laboratory for offline calculation of the three-vessel ultrasonic flow ratio (3V-UFR). Patients will be grouped by the median 3V-UFR (low vs high) and followed for one year for major adverse cardiovascular events (MACE: cardiac death, any myocardial infarction, and ischemia-driven coronary revascularization). The study tests whether lower 3V-UFR is associated with higher incidence of MACE within one year.

Who should consider this trial

Good fit: Adults (≥18 years) with coronary artery disease and ≥30% diameter stenosis in all three major coronary arteries who can safely undergo IVUS and provide informed consent are the intended participants.

Not a fit: Patients unlikely to benefit include those ineligible for IVUS, with recent (≤72 hours) myocardial infarction, prior CABG, severe heart failure, significant renal impairment, contrast or adenosine allergy, life expectancy under two years, or coronary anatomy requiring CABG or preventing IVUS.

Why it matters

Potential benefit: If successful, the measurement could help identify patients at higher risk of heart attack or death within a year so clinicians can target closer monitoring or treatment.

How similar studies have performed: Related techniques such as fractional flow reserve (FFR) and other vessel-level flow metrics have shown prognostic value, but applying a three-vessel ultrasonic flow ratio is a newer approach with limited prior outcome data.

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 (NYHA grade ≥ III)
* 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

Where this trial is running

Beijing

• Fuwai Hospital,Chinese Academy of Medical Sciences and Peking Union Medical College — Beijing, China (Recruiting)

Study contacts

• Study coordinator: Jie Qian, MD

Conditions Coronary Artery Disease