Evaluating the accuracy of ultrasonic flow ratio for assessing left main coronary artery stenosis
Functional Diagnostic Accuracy of Ultrasonic Flow Ratio in Assessment of Left Main Coronary Artery Stenosis
This study is testing if a new ultrasound method can accurately identify serious blockages in the left main coronary artery in people who have narrowing in that area.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 120 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | China National Center for Cardiovascular Diseases Government |
| Locations | 1 site (Beijing, Select A State) |
| Trial ID | NCT06053944 on ClinicalTrials.gov |
What this trial studies
This observational study aims to assess the diagnostic accuracy of the offline computational ultrasonic flow ratio (UFR) in identifying functionally significant stenosis in the left main coronary artery. It will involve 120 patients with intermediate left main coronary vessel diameter stenosis, who will undergo intravascular ultrasound (IVUS) followed by fractional flow reserve (FFR) examination. The UFR will be calculated from IVUS images sent to an independent core laboratory, with FFR serving as the standard reference for comparison. The study is being conducted at Fuwai Hospital.
Who should consider this trial
Good fit: Ideal candidates include adults aged 18 and older with stable or unstable angina and intermediate left main coronary lesions.
Not a fit: Patients with severe heart failure, recent myocardial infarction, or those ineligible for IVUS or FFR examination may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could improve the accuracy of diagnosing significant left main coronary artery disease, leading to better patient management.
How similar studies have performed: While the use of UFR is a novel approach, similar studies using FFR as a standard have shown promising results in assessing coronary artery disease.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Stable angina pectoris, unstable angina pectoris, or after the acute phase of myocardial infarction * Age ≥18 years * Written informed consent * Intermediated left main coronary lesions (diameter stenosis of 30%-80% by visual estimation from coronary angiography) Exclusion Criteria: * Ineligible for diagnostic IVUS or FFR examination * Prior coronary artery bypass grafting of the interrogated vessels * Myocardial infarction within 72 h of coronary angiography * Severe heart failure * 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 * Proximal LAD diffuse lesions (diameter stenosis \> 50%) * IVUS pullback not covering the entire lesion * Severe myocardial bridge in the interrogated vessel
Where this trial is running
Beijing, Select A State
- Fuwai Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College — Beijing, Select A State, China (Recruiting)
Study contacts
- Principal investigator: Jie Qian — Fuwai Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College
- Study coordinator: Jie Qian, MD
- Email: qianjfw@163.com
- Phone: +8613601396650
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.