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Bicuspid Echocardiac Study Team（BEST）

Sponsor
Suzhou Municipal Hospital (Other)
Overall Status
Recruiting
CT.gov ID
NCT05656820
Collaborator
(none)
200
Enrollment
1
Location
18
Anticipated Duration (Months)
11.1
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    200 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    Prospective Cohort Study on Imaging Genetics of Bicuspid Aortic Valve
    Actual Study Start Date :
    Jul 1, 2022
    Anticipated Primary Completion Date :
    Jun 30, 2023
    Anticipated Study Completion Date :
    Dec 31, 2023

    Outcome Measures

    Primary Outcome Measures

    1. 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.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    N/A and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Suzhou Municipal Hospital Suzhou China

    Sponsors and Collaborators

    • Suzhou Municipal Hospital

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Mo Zhou, Attending physician, Suzhou Municipal Hospital
    ClinicalTrials.gov Identifier:
    NCT05656820
    Other Study ID Numbers:
    • GSKY20220407
    First Posted:
    Dec 19, 2022
    Last Update Posted:
    Dec 19, 2022
    Last Verified:
    Dec 1, 2022
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Aortic Valve Disease
    Bicuspid Aortic Valve Disease
    Heart Valve Diseases

    Study Results

    No Results Posted as of Dec 19, 2022