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Bicuspid Echocardiac Study Team（BEST）

NCT ID: NCT05656820

Last Updated: 2023-11-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

200 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-07-01

Study Completion Date

2023-12-31

Brief Summary

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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

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Conditions

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Bicuspid Aortic Valve Disease

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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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
Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Suzhou Municipal Hospital

OTHER

Sponsor Role lead

Responsible Party

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Mo Zhou

Attending physician

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Suzhou Municipal Hospital

Suzhou, , China

Site Status RECRUITING

Countries

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China

Central Contacts

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Ya Yang

Role: CONTACT

[email protected]
+86 18911662958

Facility Contacts

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Ya Yang

Role: primary

[email protected]
+86 18911662958

Other Identifiers

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GSKY20220407

Identifier Type: -

Identifier Source: org_study_id