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NCT Number: NCT06822894

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

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.

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Key information

Conditions

Coronary Artery Disease (CAD) Arterial Occlusive Diseases Arteriosclerosis Cardiovascular Diseases Coronary Artery Disease Coronary Disease Heart Diseases Myocardial Ischemia Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

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

Beijing, China

Location status: Recruiting

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Not applicable- observational study

Other

UFR is a novel IVUS-derived modality for fast computation of FFR without pressure wires and adenosine

Primary outcomes

  1. Major adverse cardiac events (MACE) at 1 year

    Time frame: 1 year after the procedure

    The primary outcome is MACE at 1 year, including cardiac death, any myocardial infarction and any ischaemia-driven revascularization.

Secondary outcomes

  1. Major adverse cardiac events (MACE) at 1 month

    Time frame: 1 month after the procedure

    MACE is defined as cardiac death, any myocardial infarction and any ischaemia-driven revascularization.

  2. Major adverse cardiac events (MACE) at 6 months

    Time frame: 6 months after the procedure

    MACE is defined as cardiac death, any myocardial infarction and any ischaemia-driven revascularization.

Study contacts

Contact information is provided by the study sponsor or research team.

Cheng Yang, MD

CONTACT

[email protected]

+8619801116690

Jie Qian, MD

CONTACT

[email protected]

+8613601396650

Sponsors and collaborators

Lead sponsor

China National Center for Cardiovascular Diseases

Other Gov

Registry information

Acronym: FUNCTION III

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Feb 12, 2025
Registry last updated
Feb 12, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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