Bicuspid Aortic Valve DiseaseBESTNCT05656820
Bicuspid Echocardiac Study Team（BEST）
An observational study of Bicuspid Aortic Valve Disease, run by Suzhou Municipal Hospital at 1 site in China.
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. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Bicuspid Aortic Valve Disease
- How many people
- 200 participants
- Where
- 1 siteChina
- Study dates
- 1 Jul 2022to 31 Dec 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: Outpatient, inpatient, physical examination or community referral patients.
Who may be able to join
- Ultrasound or other imaging tests to diagnose patients with BAV
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Suzhou Municipal Hospital
Suzhou
Ya Yang, +86 18911662958, echoyangya99@163.com
About this study
Official title: 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.
- Conditions
- Bicuspid Aortic Valve Disease
- Medical subject headings
- Bicuspid Aortic Valve Disease
What is being measured
The primary outcome is the main question the study is designed to answer.
Diameter of ascending aorta
Diameter of ascending aorta shall be taken using leading edge-to-leading edge convention at end diastole.
Measured: baseline; once a year; through study completion.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Dec 2022
- Study start1 Jul 2022
- Primary completion30 Dec 2023 (estimated)
- Study completion31 Dec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bicuspid Aortic Valve DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Suzhou Municipal Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mo Zhou, Suzhou Municipal Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05656820
- Sponsor's protocol ID
- GSKY20220407
- Acronym
- BEST
- Status last verified
- Nov 2023
- First submitted
- 28 Nov 2022
- Last updated
- 22 Nov 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Cohort Study on Imaging Genetics of Bicuspid Aortic Valve
- ClinicalTrials.gov ID
- NCT05656820
- Acronym / sponsor ID
- BEST / GSKY20220407
- Conditions
- Bicuspid Aortic Valve Disease
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Suzhou Municipal HospitalUniversity, hospital or other
- Study start
- 1 Jul 2022 (actual)
- Primary completion
- 30 Dec 2023 (estimated)
- Study completion
- 31 Dec 2023 (estimated)
- First posted
- 19 Dec 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Outpatient, inpatient, physical examination or community referral patients.
Key inclusion criteria (1 listed)
- Ultrasound or other imaging tests to diagnose patients with BAV
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Diameter of ascending aorta
Time frame: baseline; once a year; through study completion.
Diameter of ascending aorta shall be taken using leading edge-to-leading edge convention at end diastole.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Nov 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Bicuspid Aortic Valve Disease, run by Suzhou Municipal Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 22 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ya Yang (+86 18911662958, echoyangya99@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Diameter of ascending aorta (time frame: baseline; once a year; through study completion.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Nov 2023; AzTrials last refreshed its copy on 26 Oct 2026.