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NCT06822894Recruiting

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

Source: ClinicalTrials.gov · Last updated 12 Feb 2026

Brief summary (registry, in English)

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.

Status (registry)
Recruiting
Study type
Observational
Enrollment
494 (estimated)
First submitted
7 Feb 2025
Start date
18 Jun 2025
Primary completion date
31 Dec 2026
Lead sponsor
China National Center for Cardiovascular Diseases
NCT number
NCT06822894

What you commit to

  • Study type: Observational
  • Planned participants: 494
  • From 18 Jun 2025 to the primary completion date, 31 Dec 2026
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Prior coronary artery bypass grafting (CABG)

Other illness

  • Myocardial infarction within 72 hours of coronary angiography
  • Severe heart failure (NYHA grade ≥ III)
  • Allergy to the contrast agent or adenosine
  • Severe coronary artery disease requiring CABG identified during angiography

Lab values

  • Serum creatinine levels \>150 umol/L, or glomerular filtration rates \<45 ml/ kg/1.73 m2

Age

  • Life expectancy \< 2 years

Other

  • Ineligible for diagnostic IVUS examination
  • Extreme vascular tortuosity precluding IVUS catheter advancement
  • Suboptimal IVUS image quality impairing quantitative analysis

Who the study is looking for

  • 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

Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Fuwai Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College
Coordinator of this site? Confirm its status
BeijingChinaRecruiting

This page is information, not medical advice. Discuss any trial with your doctor.