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Study on Genetically Affected Sporadic Thoracic Aortic Aneurysm and Dissection (GenSTAND)

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ClinicalTrials.gov Identifier: NCT02852603
Recruitment Status : Recruiting
First Posted : August 2, 2016
Last Update Posted : November 6, 2017
Sponsor:
Collaborator:
Fu Wai Hospital, Beijing, China
Information provided by (Responsible Party):
Xuan Zheng, Wuhan Asia Heart Hospital

Brief 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 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.

Condition or disease
Dissection of Aorta, Thoracic Aneurysm of Aorta, Thoracic

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
Estimated Enrollment : 500 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Study on Genetically Affected Sporadic Thoracic Aortic Aneurysm and Dissection
Study Start Date : August 2014
Estimated Primary Completion Date : December 2018
Study Completion Date : June 2019

Resource links provided by the National Library of Medicine


Group/Cohort
thoracic aortic aneurysm and dissection
Patients with thoracic aortic aneurysm and/or dissection are recruited in the study.



Primary Outcome Measures :
  1. 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 ]

Biospecimen Retention:   Samples With DNA
Peripheral whole blood is obtained from patients. Serum, blood cell and DNA are separated and stored for further study.


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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients with thoracic aortic aneurysm and dissection.
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02852603


Contacts
Contact: Xuan Zheng, MD, PhD 86-2765796888 ext 8506 soniazheng@live.cn
Contact: Yuanping Hu 86-2765796888 ext 8501 1875281280@qq.com

Locations
China, Hubei
Wuhan Asia Heart Hospital Recruiting
Wuhan, Hubei, China, 430022
Contact: Xuan Zheng, MD, PhD    +86-2765796888 ext 8506    soniazheng@live.cn   
Sub-Investigator: Xuan Zheng, MD, PhD         
Sponsors and Collaborators
Wuhan Asia Heart Hospital
Fu Wai Hospital, Beijing, China

Responsible Party: Xuan Zheng, vice director of laboratory of molecular cardiology, Wuhan Asia Heart Hospital
ClinicalTrials.gov Identifier: NCT02852603     History of Changes
Other Study ID Numbers: 2016LMC-2
First Posted: August 2, 2016    Key Record Dates
Last Update Posted: November 6, 2017
Last Verified: October 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Keywords provided by Xuan Zheng, Wuhan Asia Heart Hospital:
dissection
aneurysm
thoracic aorta

Additional relevant MeSH terms:
Aneurysm
Aortic Aneurysm
Aortic Aneurysm, Thoracic
Vascular Diseases
Cardiovascular Diseases
Aortic Diseases