Three-vessel ultrasonic flow ratio to predict one-year heart risk in people with coronary artery disease
Official title: Clinical Implications of Three-vessel Ultrasonic Flow Ratio Measurement in Patients With Coronary Artery Disease
Run by China National Center for Cardiovascular Diseases · NCT06822894 · Data updated 2026-11-12
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 |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 494 (estimated) |
| Sponsor | China National Center for Cardiovascular Diseases Government |
| Locations | 1 site (Beijing) |
| Status | Recruiting |
| Started | June 18, 2025 |
| Main results expected | December 31, 2026 |
| Study ends | December 31, 2026 |
| Registry record updated | February 12, 2026 |
| Trial ID | NCT06822894 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a 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.
✕Probably 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.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
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.
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 gone: 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.
Who can join: the full rules
Show full inclusion / exclusion 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 it's running
-
Fuwai Hospital,Chinese Academy of Medical Sciences and Peking Union Medical College
Beijing, China Recruiting
Study contacts
- Study coordinator: Jie Qian, MD
- Email: qianjfw@163.com
- Phone: +8613601396650
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.