Clinical Implications of Three-vessel Ultrasonic Flow Ratio Measurement in Patients With Coronary Artery Disease
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Not applicable- observational study.
- Who it may be relevant to
- Registry conditions: Coronary Artery Disease (CAD). Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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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.
Interventions
- Other Not applicable- observational study
UFR is a novel IVUS-derived modality for fast computation of FFR without pressure wires and adenosine
Primary outcome measures
- Major adverse cardiac events (MACE) at 1 year [Time frame: 1 year after the procedure]
Secondary outcome measures (2)
- Major adverse cardiac events (MACE) at 1 month [Time frame: 1 month after the procedure]
- Major adverse cardiac events (MACE) at 6 months [Time frame: 6 months after the procedure]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
China · 1 center
- Fuwai Hospital,Chinese Academy of Medical Sciences and Peking Union Medical College — Beijing
Identifiers
NCT: NCT06822894 · 2024-2-4034