Status:
UNKNOWN
Functional Diagnostic Accuracy of Ultrasonic Flow Ratio in Assessment of Left Main Coronary Artery Stenosis
Lead Sponsor:
China National Center for Cardiovascular Diseases
Conditions:
Left Main Coronary Artery Disease
Eligibility:
All Genders
18+ years
Brief Summary
This is a prospective, observational, single-center study. The main purpose of this study is to evaluate the diagnostic accuracy of offline computational ultrasonic flow ratio (UFR) in predicting func...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
October 18 2023
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
December 31 2024
Estimated Enrollment :
120 Patients enrolled
Trial Details
Trial ID
NCT06053944
Start Date
October 18 2023
End Date
December 31 2024
Last Update
January 22 2024
Active Locations (1)
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1
Fuwai Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College
Beijing, Select A State, China, 100037