- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02852603
Study on Genetically Affected Sporadic Thoracic Aortic Aneurysm and Dissection (GenSTAND)
April 11, 2021 updated by: Xuan Zheng, Wuhan Asia Heart Hospital
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.
Study Overview
Status
Completed
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 Type
Observational
Enrollment (Actual)
450
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Hubei
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Wuhan, Hubei, China, 430022
- Wuhan Asia Heart Hospital
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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
18 years to 80 years (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
Patients with thoracic aortic aneurysm and dissection.
Description
Inclusion Criteria:
- Patients with thoracic aortic aneurysm and dissection not due to trauma
Exclusion Criteria:
- Inability of the patient, parent or guardian to give consent
- Unwillingness to provide a blood specimen or participate in the study
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
Cohorts and Interventions
Group / Cohort |
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thoracic aortic aneurysm and dissection
Patients with thoracic aortic aneurysm and/or dissection are recruited in the study.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
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Arterial dissection actually happened
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6 months
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Xuan Zheng, MD, PhD, Wuhan Asia Heart Hospital
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)
August 1, 2014
Primary Completion (ACTUAL)
January 1, 2019
Study Completion (ACTUAL)
January 1, 2020
Study Registration Dates
First Submitted
July 27, 2016
First Submitted That Met QC Criteria
August 1, 2016
First Posted (ESTIMATE)
August 2, 2016
Study Record Updates
Last Update Posted (ACTUAL)
April 13, 2021
Last Update Submitted That Met QC Criteria
April 11, 2021
Last Verified
April 1, 2021
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2016LMC-2
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
UNDECIDED
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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