Actively Recruiting
Clinical Implications of Three-vessel Ultrasonic Flow Ratio Measurement in Patients With Coronary Artery Disease
Led by China National Center for Cardiovascular Diseases · Updated on 2026-02-12
494
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are investigating the value of a new ultrasound-based measurement called the three coronary vessel-ultrasonic flow ratio (3V-UFR) to predict serious heart problems known as major adverse cardiovascular events (MACE) in patients with coronary artery disease. This observational study will include at least 494 patients who have significant narrowing (50% or more) in all three main coronary arteries. The study aims to understand how well 3V-UFR can help forecast heart events within one year after measurement. Participants who qualify will undergo intravascular ultrasound (IVUS), a procedure that captures images inside the coronary arteries. These images will be analyzed by a specialized laboratory to calculate the 3V-UFR. Following this, patients will be monitored for one year to track the occurrence of major heart problems such as cardiac death, heart attacks, or the need for further heart procedures. The study will compare patients with low and high 3V-UFR values to explore its clinical usefulness. During the study, researchers will collect data from the IVUS procedure and track heart-related events at one month, six months, and one year after the procedure. The main outcome measured is the rate of major adverse cardiac events within one year. The study is conducted by the China National Center for Cardiovascular Diseases and focuses on improving care for individuals with coronary artery disease by better assessing their risk of future heart problems.
CONDITIONS
Brief Title
Clinical Implications of Three-vessel Ultrasonic Flow Ratio Measurement in Patients With Coronary Artery Disease
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Stable angina pectoris, unstable angina pectoris, or after the acute phase of myocardial infarction
- Age 18 years or older
- Written informed consent
- Angiographically confirmed 50% or more 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
You will not qualify if you...
- Ineligible for diagnostic intravascular ultrasound (IVUS) examination
- Prior coronary artery bypass grafting (CABG)
- Myocardial infarction within 72 hours of coronary angiography
- Severe heart failure (New York Heart Association grade 3 or higher)
- Serum creatinine levels greater than 150 umol/L or glomerular filtration rates less than 45 ml/kg/1.73 m2
- Allergy to the contrast agent or adenosine
- Life expectancy less than 2 years
- Severe coronary artery disease requiring CABG identified during angiography
- Extreme vascular tortuosity preventing IVUS catheter advancement
- Suboptimal IVUS image quality impairing quantitative analysis
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 1 day
Participants undergo intravascular ultrasound (IVUS) examination for measurement of ultrasonic flow ratio without pressure wires and adenosine.
1 visit (in-person)
Duration - 1 year
Participants are monitored for major adverse cardiac events (MACE) over 1 year following the procedure.
Follow-up visits at 1 month, 6 months, and 1 year
Trial Site Locations
Total: 1 location
1
Fuwai Hospital,Chinese Academy of Medical Sciences and Peking Union Medical College
Beijing, China
Actively Recruiting
Research Team
J
Jie Qian, MD
C
Cheng Yang, MD
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
0
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