Bicuspid Echocardiac Study Team（BEST）

Recruiting

• Conditions: Bicuspid Aortic Valve Disease

• Registration Number: NCT05656820
• Lead Sponsor: Suzhou Municipal Hospital

Brief Summary

The Chinese Bicuspid Aortic Valve (BAV) Ultrasound imaging cohort study is a Chinese BAV ultrasound imaging cohort study. At present, a retrospective study cohort involving more than 30 hospitals has been established. The prospective multi-center study of BAV is expected to include and follow up 200 outpatients and inpatients with BAV. The clinical, ultrasound imaging and treatment parameters of the patients are collected and the patients are followed up for 2 years. To analyze the prognostic characteristics of BAV patients and establish a Chinese BAV database. The primary endpoint was all-cause death, and the secondary endpoints were heart failure, angina, severe aortic stenosis, severe aortic insufficiency, ascending aortic diameter ≥50mm, and surgery (surgical and interventional). According to the different pathological types of aortic valve in different types of BAV, ultrasound imaging was used to evaluate the different forms of valvular leaflet lesions and prognosis. Finally, it provides a basis for the prognosis, treatment method, treatment timing and treatment plan selection of BAV patients, and lays a foundation for the mechanism study of BAV arterial lesions and the establishment of risk model for the prognosis of BAV patients.

Detailed Description

Not available

Study Timeline

• Study Start: 2022-07-01
• Study First Submitted: 2022-11-28
• Study First Submitted QC: 2022-12-15
• Study First Posted: 2022-12-19
• Status Verified: 2023-11
• Last Update Submitted: 2023-11-20
• Last Update Posted: 2023-11-22
• Primary Completion: 2023-12-30
• Study Completion: 2023-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 200

Inclusion Criteria

• Ultrasound or other imaging tests to diagnose patients with BAV

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Exclusion Criteria

• Patients with TAV or/and have significant aortic valve calcification
• Those deemed unsuitable for enrollment by clinicians (e.g., end-stage patients, mentally ill patients, non-cooperating patients, etc.)
• Those who do not agree to be included

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Diameter of ascending aorta	baseline; once a year; through study completion.	Diameter of ascending aorta shall be taken using leading edge-to-leading edge convention at end diastole.

Trial Locations

Locations (1)

Suzhou Municipal Hospital; 🇨🇳 Suzhou, China