Bicuspid Aortic ValveNCT05818722
A Multicentre Retrospective Study on Bicuspid Aortic Valve
An observational study of Bicuspid Aortic Valve, run by The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School at 1 site in China.
Trial summary
Bicuspid Aortic Valve (BAV) is a common congenital heart disease with an incidence ranging from 0.16% in Asians to 2% in Westerners. Asian populations with BAV have different morphological characteristics from those of the Western populations, and further elucidation of these differences will serve as a guide for the… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Bicuspid Aortic Valve
- How many people
- 1,000 participants
- Where
- 1 siteChina
- Study dates
- 1 Dec 2022to 1 Dec 2025
- 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
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients with Bicuspid Aortic Valve
Who may be able to join
- All patients with a suspected diagnosis of Bicuspid Aortic Valve by echocardiogram from December 2021 to October 2022
Who cannot join
- Patients with suspected Bicuspid Aortic Valve not clearly diagnosed by echocardiography and not confirmed by cardiac surgery
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Affiliated Drum Tower Hospital of Nanjing University Medical School
Nanjing, Jiangsu, 210008
Jing Yao, Phd, +18905188727, w18351992709@163.com
About this study
Official title: Multicentre Retrospective Analysis of the Characteristics and the Long-term Prognosis of the Bicuspid Aortic Valve
Bicuspid Aortic Valve (BAV) is a common congenital heart disease with an incidence ranging from 0.16% in Asians to 2% in Westerners. Asian populations with BAV have different morphological characteristics from those of the Western populations, and further elucidation of these differences will serve as a guide for the treatment and follow-up of Asian patients. Therefore, we conducted this multicentre retrospective study to analysis the clinical features, long-term development and surgical prognosis of BAV .
Read the detailed description
Bicuspid Aortic Valve (BAV) is a common congenital heart disease with an incidence ranging from 0.16% in Asians to 2% in Westerners, and more than one half of patients require medical or surgical treatment within 20 years of diagnosis. Therefore, early diagnosis and effective treatment can help to reduce the incidence of irreversible cardiac impairment and adverse outcomes such as sudden death. Asian populations with BAV have morphological characteristics that differ from those of the Western populations, and further elucidation of these differences could serve as a guide for the treatment and follow-up of Chinese patients. Based on the above background, We conducted this multicentre retrospective study. We will search for patients diagnosed with BAV by echocardiography or other imaging examinations from December 2021 to October 2022 at Nanjing Gulou Hospital, Jiangsu Provincial Hospital and Nanjing Children's Hospital; collect clinical symptoms, signs and examination results of them; find out the specific surgical plan and time of surgery if they have undergone surgery; follow up for symptoms, medication and reexamin Echocardiography to confirm any endpoint events.
- Conditions
- Bicuspid Aortic Valve
- Keywords
- Bicuspid Aortic Valve, Echocardiography, Long-term progress
- Medical subject headings
- Bicuspid Aortic Valve Disease
What is being measured
The primary outcome is the main question the study is designed to answer.
All-cause death
Death from any causes
Measured: 1 year
Cardical mortality
Death due to cardiac disease including MI, arrhythmia, heart failure and aortic lesions
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Apr 2023
- Study start1 Dec 2022
- Primary completion1 Dec 2024 (estimated)
- Study completion1 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Bicuspid Aortic ValveStudies 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
- Other
- Time perspective
- Retrospective
- Enrolment
- 1,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
- Sponsor type
- University, hospital or other
- Collaborators
- The First Affiliated Hospital with Nanjing Medical University, Nanjing Children's Hospital
- Responsible party
- Sponsor
- Investigators
- Jing Yao, Phd, Study director, The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05818722
- Sponsor's protocol ID
- 2022-671
- Status last verified
- Feb 2023
- First submitted
- 21 Feb 2023
- Last updated
- 19 Apr 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Lee M, Sung J, Cho SJ, Choi SH, Cho SW, Oh JK, Park SJ, Kim DK. Aortic dilatation and calcification in asymptomatic patients with bicuspid aortic valve: analysis in a Korean health screening population. Int J Cardiovasc Imaging. 2013 Mar;29(3):553-60. doi: 10.1007/s10554-012-0116-3. Epub 2012 Aug 26.
PubMed 22923281Movahed MR, Hepner AD, Ahmadi-Kashani M. Echocardiographic prevalence of bicuspid aortic valve in the population. Heart Lung Circ. 2006 Oct;15(5):297-9. doi: 10.1016/j.hlc.2006.06.001. Epub 2006 Aug 17.
PubMed 16914375Fedak PWM. Bicuspid aortic valve and the specialty clinic: are your patients at risk? Cardiol Young. 2017 Apr;27(3):411-412. doi: 10.1017/S1047951117000282. Epub 2017 Mar 6. No abstract available.
PubMed 28260551Lo Presti F, Guzzardi DG, Bancone C, Fedak PWM, Della Corte A. The science of BAV aortopathy. Prog Cardiovasc Dis. 2020 Jul-Aug;63(4):465-474. doi: 10.1016/j.pcad.2020.06.009. Epub 2020 Jun 26.
PubMed 32599028Fernandes JF, Gill H, Nio A, Faraci A, Galli V, Marlevi D, Bissell M, Ha H, Rajani R, Mortier P, Myerson SG, Dyverfeldt P, Ebbers T, Nordsletten DA, Lamata P. Non-invasive cardiovascular magnetic resonance assessment of pressure recovery distance after aortic valve stenosis. J Cardiovasc Magn Reson. 2023 Jan 30;25(1):5. doi: 10.1186/s12968-023-00914-3.
PubMed 36717885
Study at a glance
From the registry record, last updated by the sponsor on 19 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multicentre Retrospective Analysis of the Characteristics and the Long-term Prognosis of the Bicuspid Aortic Valve
- ClinicalTrials.gov ID
- NCT05818722
- Acronym / sponsor ID
- 2022-671
- Conditions
- Bicuspid Aortic Valve
- Keywords
- Bicuspid Aortic Valve, Echocardiography, Long-term progress
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical SchoolUniversity, hospital or other
- Collaborators
- The First Affiliated Hospital with Nanjing Medical University, Nanjing Children's Hospital
- Study start
- 1 Dec 2022 (actual)
- Primary completion
- 1 Dec 2024 (estimated)
- Study completion
- 1 Dec 2025 (estimated)
- First posted
- 19 Apr 2023 (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.
Bicuspid Aortic Valve (BAV) is a common congenital heart disease with an incidence ranging from 0.16% in Asians to 2% in Westerners. Asian populations with BAV have different morphological characteristics from those of the Western populations, and further elucidation of these differences will serve as a guide for the treatment and follow-up of Asian patients. Therefore, we conducted this multicentre retrospective study to analysis the clinical features, long-term development and surgical prognosis of BAV .
Detailed description
Bicuspid Aortic Valve (BAV) is a common congenital heart disease with an incidence ranging from 0.16% in Asians to 2% in Westerners, and more than one half of patients require medical or surgical treatment within 20 years of diagnosis. Therefore, early diagnosis and effective treatment can help to reduce the incidence of irreversible cardiac impairment and adverse outcomes such as sudden death. Asian populations with BAV have morphological characteristics that differ from those of the Western populations, and further elucidation of these differences could serve as a guide for the treatment and follow-up of Chinese patients. Based on the above background, We conducted this multicentre retrospective study. We will search for patients diagnosed with BAV by echocardiography or other imaging examinations from December 2021 to October 2022 at Nanjing Gulou Hospital, Jiangsu Provincial Hospital and Nanjing Children's Hospital; collect clinical symptoms, signs and examination results of them; find out the specific surgical plan and time of surgery if they have undergone surgery; follow up for symptoms, medication and reexamin Echocardiography to confirm any endpoint events.
Study design
- Observational model
- Other
- Time perspective
- Retrospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients with Bicuspid Aortic Valve
Key inclusion criteria (1 listed)
- All patients with a suspected diagnosis of Bicuspid Aortic Valve by echocardiogram from December 2021 to October 2022
Key exclusion criteria (1 listed)
- Patients with suspected Bicuspid Aortic Valve not clearly diagnosed by echocardiography and not confirmed by cardiac surgery
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
All-cause death
Time frame: 1 year
Death from any causes
Cardical mortality
Time frame: 1 year
Death due to cardiac disease including MI, arrhythmia, heart failure and aortic lesions
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Apr 2023.
- Background: PubMed 22923281Lee M, Sung J, Cho SJ, Choi SH, Cho SW, Oh JK, Park SJ, Kim DK. Aortic dilatation and calcification in asymptomatic patients with bicuspid aortic valve: analysis in a Korean health screening population. Int J Cardiovasc Imaging. 2013 Mar;29(3):553-60. doi: 10.1007/s10554-012-0116-3. Epub 2012 Aug 26.
- Background: PubMed 16914375Movahed MR, Hepner AD, Ahmadi-Kashani M. Echocardiographic prevalence of bicuspid aortic valve in the population. Heart Lung Circ. 2006 Oct;15(5):297-9. doi: 10.1016/j.hlc.2006.06.001. Epub 2006 Aug 17.
- Background: PubMed 28260551Fedak PWM. Bicuspid aortic valve and the specialty clinic: are your patients at risk? Cardiol Young. 2017 Apr;27(3):411-412. doi: 10.1017/S1047951117000282. Epub 2017 Mar 6. No abstract available.
- Background: PubMed 32599028Lo Presti F, Guzzardi DG, Bancone C, Fedak PWM, Della Corte A. The science of BAV aortopathy. Prog Cardiovasc Dis. 2020 Jul-Aug;63(4):465-474. doi: 10.1016/j.pcad.2020.06.009. Epub 2020 Jun 26.
- Background: PubMed 36717885Fernandes JF, Gill H, Nio A, Faraci A, Galli V, Marlevi D, Bissell M, Ha H, Rajani R, Mortier P, Myerson SG, Dyverfeldt P, Ebbers T, Nordsletten DA, Lamata P. Non-invasive cardiovascular magnetic resonance assessment of pressure recovery distance after aortic valve stenosis. J Cardiovasc Magn Reson. 2023 Jan 30;25(1):5. doi: 10.1186/s12968-023-00914-3.
- Individual participant dataSharing planned: Undecided
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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.
Jing Yao, Phd study director
The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
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, run by The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School 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 1 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 19 Apr 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 Jing Yao, Phd (+8618905188727, w1835199709@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
All-cause death (time frame: 1 year). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05818722, which also lists 5 linked publications.
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 19 Apr 2023.