Bicuspid Echocardiac Study Team（BEST）

NCT05656820 | Unknown

• 1 other identifier: GSKY20220407
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 1

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.

Conditions

Bicuspid Aortic Valve Disease

Outcome Measures

Primary Outcomes (1)

• 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.

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Outpatient, inpatient, physical examination or community referral patients.

You may qualify if:

• Ultrasound or other imaging tests to diagnose patients with BAV

You may not qualify if:

• 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

Sponsors & Collaborators

• Suzhou Municipal Hospital: lead

Study Sites (1)

Suzhou Municipal Hospital

Suzhou, China

RECRUITING

MeSH Terms

Conditions

Bicuspid Aortic Valve Disease

Condition Hierarchy (Ancestors)

Heart Defects, Congenital; Cardiovascular Abnormalities; Cardiovascular Diseases; Heart Diseases; Aortic Valve Disease; Heart Valve Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Central Study Contacts

Ya Yang

CONTACT

+86 18911662958; echoyangya99@163.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Attending physician

Study Record Dates

• First Submitted: November 28, 2022
• First Posted: December 19, 2022
• Study Start: July 1, 2022
• Primary Completion: December 30, 2023
• Study Completion: December 31, 2023
• Last Updated: November 22, 2023

Record last verified: 2023-11

Locations

CN (1)