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

NCT06822894 | Recruiting

• 1 other identifier: 2024-2-4034
• Study Type: observational
• Target: 494
• Locations: 1 country
• Sites: 1

Brief Summary

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

Coronary Artery Disease (CAD)

Outcome Measures

Primary Outcomes (1)

• Major adverse cardiac events (MACE) at 1 year

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

  1 year after the procedure

Secondary Outcomes (2)

• Major adverse cardiac events (MACE) at 1 month

  1 month after the procedure

• Major adverse cardiac events (MACE) at 6 months

  6 months after the procedure

Interventions

Not applicable- observational study OTHER

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients aged 18 years or older admitted to Fuwai Hospital (Beijing, China) for coronary angiography and demonstrating angiographically confirmed ≥30% stenosis in all three major coronary arteries through visual assessment, will be consecutively enrolled in the study.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• China National Center for Cardiovascular Diseases: lead

Study Sites (1)

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

Beijing, China

RECRUITING

MeSH Terms

Conditions

Coronary Artery Disease

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases

Central Study Contacts

Jie Qian, MD

CONTACT

+8613601396650; qianjfw@163.com

Cheng Yang, MD

CONTACT

+8619801116690; yangcheng_fw@163.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Year
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 7, 2025
• First Posted: February 12, 2025
• Study Start: June 18, 2025
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: February 12, 2026

Record last verified: 2025-02

Locations

CN (1)