Dissection of Aorta, ThoracicGenSTANDNCT02852603
Study on Genetically Affected Sporadic Thoracic Aortic Aneurysm and Dissection
An observational study of Dissection of Aorta, Thoracic and Aneurysm of Aorta, Thoracic, run by Wuhan Asia Heart Hospital at 1 site in China.
Trial summary
Mortality of thoracic aortic aneurysm and dissection (TAAD) remains high because of the huge blood lost from the aorta. Questions about the potentially genetic effects on sporadic TAAD are raised by researchers to explore the possible mechanisms leading to sporadic TAAD and to establish new clinical approaches to… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Dissection of Aorta, Thoracic, Aneurysm of Aorta, Thoracic
- How many people
- 450 participants
- Where
- 1 siteChina
- Study dates
- Aug 2014to Jan 2020
- 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 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with thoracic aortic aneurysm and dissection.
Who may be able to join
- Patients with thoracic aortic aneurysm and dissection not due to trauma
Who cannot join
- Inability of the patient, parent or guardian to give consent
- Unwillingness to provide a blood specimen or participate in the study
Trial locations and contacts
1 site in 1 country.
About this study
Mortality of thoracic aortic aneurysm and dissection (TAAD) remains high because of the huge blood lost from the aorta. Questions about the potentially genetic effects on sporadic TAAD are raised by researchers to explore the possible mechanisms leading to sporadic TAAD and to establish new clinical approaches to prevent TAAD-caused adverse clinical outcomes. This study is intended to collect the gene information in sporadic TAAD patients and to explore the relationship between genetic variation and the incidence of sporadic TAAD for further study.
Read the detailed description
Thoracic aortic dissection (TAD) is a critical clinical condition partly due to the rupture of aortic aneurysm. Mostly, surgical treatment can reduce the symptoms and extend life span of patients with thoracic aortic aneurysm and dissection (TAAD). However, mortality of TAAD remains high because of the huge blood lost from the aorta. Sporadic TAAD was considered to be a server consequence of hypertension, though most patients with hypertension won't have TAAD as their final outcomes. Previous studies have revealed the associations between genetic abnormalities and familial TAAD, and genetic tests have applied to assist the diagnosis of certain TAAD. Therefore, the potentially genetic effects on sporadic TAAD are explored by researchers to understand the possible mechanisms leading to sporadic TAAD and to establish new clinical approaches to prevent TAAD-caused adverse clinical outcomes. This study is intended to collect the gene information in sporadic TAAD patients and to explore the relationship between genetic variation and the incidence of sporadic TAAD for further study.
- Keywords
- dissection, aneurysm, thoracic aorta
- Medical subject headings
- Aortic Dissection, Aortic Aneurysm, Aneurysm
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| thoracic aortic aneurysm and dissection | Patients with thoracic aortic aneurysm and/or dissection are recruited in the study. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Numbers of patients having thoracic aortic aneurysm and/or dissection are recorded. Diagnosis are confirmed by imaging analysis (CTA and/or Ultrasound) or by doctors during the operations.
Arterial dissection actually happened
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Aug 2016 (estimated)
- Study startAug 2014
- Primary completionJan 2019
- Study completionJan 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dissection of Aorta, ThoracicStudies 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
- Retrospective
- Enrolment
- 450 participants (actual)
Sponsor and investigators
- Lead sponsor
- Wuhan Asia Heart Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Fu Wai Hospital, Beijing, China
- Responsible party
- Principal investigator, Xuan Zheng, Wuhan Asia Heart Hospital
- Investigators
- Xuan Zheng, MD, PhD, Principal investigator, Wuhan Asia Heart Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02852603
- Sponsor's protocol ID
- 2016LMC-2
- Acronym
- GenSTAND
- Status last verified
- Apr 2021
- First submitted
- 27 Jul 2016
- Last updated
- 13 Apr 2021
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 13 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study on Genetically Affected Sporadic Thoracic Aortic Aneurysm and Dissection
- ClinicalTrials.gov ID
- NCT02852603
- Acronym / sponsor ID
- GenSTAND / 2016LMC-2
- Keywords
- dissection, aneurysm, thoracic aorta
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 450 participants (actual)
- Lead sponsor
- Wuhan Asia Heart HospitalUniversity, hospital or other
- Collaborators
- Fu Wai Hospital, Beijing, China
- Study start
- Aug 2014 (actual)
- Primary completion
- Jan 2019 (actual)
- Study completion
- Jan 2020 (actual)
- First posted
- 2 Aug 2016 (estimated)
- 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.
Mortality of thoracic aortic aneurysm and dissection (TAAD) remains high because of the huge blood lost from the aorta. Questions about the potentially genetic effects on sporadic TAAD are raised by researchers to explore the possible mechanisms leading to sporadic TAAD and to establish new clinical approaches to prevent TAAD-caused adverse clinical outcomes. This study is intended to collect the gene information in sporadic TAAD patients and to explore the relationship between genetic variation and the incidence of sporadic TAAD for further study.
Detailed description
Thoracic aortic dissection (TAD) is a critical clinical condition partly due to the rupture of aortic aneurysm. Mostly, surgical treatment can reduce the symptoms and extend life span of patients with thoracic aortic aneurysm and dissection (TAAD). However, mortality of TAAD remains high because of the huge blood lost from the aorta. Sporadic TAAD was considered to be a server consequence of hypertension, though most patients with hypertension won't have TAAD as their final outcomes. Previous studies have revealed the associations between genetic abnormalities and familial TAAD, and genetic tests have applied to assist the diagnosis of certain TAAD. Therefore, the potentially genetic effects on sporadic TAAD are explored by researchers to understand the possible mechanisms leading to sporadic TAAD and to establish new clinical approaches to prevent TAAD-caused adverse clinical outcomes. This study is intended to collect the gene information in sporadic TAAD patients and to explore the relationship between genetic variation and the incidence of sporadic TAAD for further study.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| thoracic aortic aneurysm and dissection | – | –Patients with thoracic aortic aneurysm and/or dissection are recruited in the study. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with thoracic aortic aneurysm and dissection.
Key inclusion criteria (1 listed)
- Patients with thoracic aortic aneurysm and dissection not due to trauma
Key exclusion criteria (2 listed)
- Inability of the patient, parent or guardian to give consent
- Unwillingness to provide a blood specimen or participate in the study
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
Numbers of patients having thoracic aortic aneurysm and/or dissection are recorded. Diagnosis are confirmed by imaging analysis (CTA and/or Ultrasound) or by doctors during the operations.
Time frame: 6 months
Arterial dissection actually happened
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Apr 2021.
- 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.
Xuan Zheng, MD, PhD principal investigator
Wuhan Asia Heart Hospital
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 Dissection of Aorta, Thoracic and Aneurysm of Aorta, Thoracic, run by Wuhan Asia Heart 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 2 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: finished, as of the sponsor's last update on 13 Apr 2021. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Numbers of patients having thoracic aortic aneurysm and/or dissection are recorded. Diagnosis are confirmed by imaging analysis (CTA and/or Ultrasound) or by doctors during the operations. (time frame: 6 months). 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 13 Apr 2021.