Bicuspid Echocardiac Study Team（BEST）

Bicuspid Aortic Valve Disease Clinical Trial

— BEST  

Official title:

Prospective Cohort Study on Imaging Genetics of Bicuspid Aortic Valve

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05656820
• Other study ID #: GSKY20220407
• Status: Recruiting
• Start date: July 1, 2022
• Est. completion date: December 31, 2023

Study information

• Verified date: November 2023
• Source: Suzhou Municipal Hospital
• Contact: Ya Yang
• Phone: +86 18911662958
• Email: echoyangya99[@]163.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: December 31, 2023
• Est. primary completion date: December 30, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• Ultrasound or other imaging tests to diagnose patients with BAV

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

Related Conditions & MeSH terms

• Aortic Valve Disease
• Bicuspid Aortic Valve Disease
• Heart Valve Diseases

Locations

Country	Name	City	State
China	Suzhou Municipal Hospital	Suzhou

Sponsors (1)

Lead Sponsor	Collaborator
Suzhou Municipal Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Diameter of ascending aorta	Diameter of ascending aorta shall be taken using leading edge-to-leading edge convention at end diastole.	baseline; once a year; through study completion.