Actively Recruiting

Age: 18Years +
All Genders
NCT06822894

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

80 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

This is a prospective, observational, single-center study. The main purpose of this study is to explore the predictive value of three coronary vessel-ultrasonic flow ratio (3V-UFR) for major adverse cardiovascular events (MACE) in patients with coronary artery disease within one year. The study will be conducted in Fuwai Hospital, and a total of at least 494 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). IVUS imaging will be sent to an independent core laboratory for offline UFR calculation. Subsequently, a one-year follow-up was conducted on the patients. The primary endpoint was MACE within one year, which included cardiac death, any myocardial infarction, and ischemia-driven coronary revascularization. The association between the 3V-UFR (low 3V-UFR and high 3V-UFR grouped by median of 3V-UFR) and MACE is investigated, to determine its role in clinical prognosis for patient with coronary artery disease.

CONDITIONS

Official Title

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

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

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 30% or greater 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
Not Eligible

You will not qualify if you...

  • Not eligible for diagnostic intravascular ultrasound (IVUS) examination
  • Prior coronary artery bypass grafting (CABG)
  • Myocardial infarction within 72 hours before coronary angiography
  • Severe heart failure (New York Heart Association grade III or higher)
  • Serum creatinine levels greater than 150 umol/L or glomerular filtration rates less than 45 ml/kg/1.73 m2
  • Allergy to 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
  • Poor IVUS image quality that affects quantitative analysis

AI-Screening

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Trial Site Locations

Total: 1 location

1

Fuwai Hospital,Chinese Academy of Medical Sciences and Peking Union Medical College

Beijing, China

Actively Recruiting

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Research Team

J

Jie Qian, MD

CONTACT

C

Cheng Yang, MD

CONTACT

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