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

China National Center for Cardiovascular Diseases494 enrolled

Overview

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.

Study Type

OBSERVATIONAL

Enrollment

494

Conditions

Coronary Artery Disease (CAD)

Interventions

Not applicable- observational study

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

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.

Time frame: 1 year after the procedure

Secondary Outcomes

Major adverse cardiac events (MACE) at 1 month

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

Time frame: 1 month after the procedure

Major adverse cardiac events (MACE) at 6 months