- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05656820
Bicuspid Echocardiac Study Team(BEST) (BEST)
November 20, 2023 updated by: Mo Zhou, Suzhou Municipal Hospital
Prospective Cohort Study on Imaging Genetics of Bicuspid Aortic Valve
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.
Study Overview
Status
Recruiting
Conditions
Study Type
Observational
Enrollment (Estimated)
200
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Ya Yang
- Phone Number: +86 18911662958
- Email: echoyangya99@163.com
Study Locations
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Suzhou, China
- Recruiting
- Suzhou Municipal Hospital
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Contact:
- Ya Yang
- Phone Number: +86 18911662958
- Email: echoyangya99@163.com
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Yes
Sampling Method
Non-Probability Sample
Study Population
Outpatient, inpatient, physical examination or community referral patients.
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Prospective
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Diameter of ascending aorta
Time Frame: baseline; once a year; through study completion.
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Diameter of ascending aorta shall be taken using leading edge-to-leading edge convention at end diastole.
|
baseline; once a year; through study completion.
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
July 1, 2022
Primary Completion (Estimated)
December 30, 2023
Study Completion (Estimated)
December 31, 2023
Study Registration Dates
First Submitted
November 28, 2022
First Submitted That Met QC Criteria
December 15, 2022
First Posted (Actual)
December 19, 2022
Study Record Updates
Last Update Posted (Estimated)
November 22, 2023
Last Update Submitted That Met QC Criteria
November 20, 2023
Last Verified
November 1, 2023
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- GSKY20220407
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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