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Trial record 6 of 100 for:    "thoracic aortic aneurysms and aortic dissections" OR "Aortic Aneurysm, Thoracic"

A Registry Study on Genetics and Biomarkers of Thoracic Aortic Aneurysm/Dissection (ARSGBTAAD)

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ClinicalTrials.gov Identifier: NCT03010514
Recruitment Status : Recruiting
First Posted : January 5, 2017
Last Update Posted : January 5, 2017
Sponsor:
Information provided by (Responsible Party):
Beijing Institute of Heart, Lung and Blood Vessel Diseases

Brief Summary:
This is a national registry study to determine genetic risk factor and serial biomarkers of thoracic aortic aneurysm/dissection

Condition or disease
Aortic Aneurysm, Thoracic Aneurysm, Dissecting

Study Type : Observational
Estimated Enrollment : 600 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: A Chinese Registry to Determine the Genetic Risk Factors and Serumal Biomarkers for Thoracic Aortic Aneurysm/Dissection
Study Start Date : October 2016
Estimated Primary Completion Date : April 2019
Estimated Study Completion Date : October 2019

Resource links provided by the National Library of Medicine


Group/Cohort
case
control



Primary Outcome Measures :
  1. Age for each participant [ Time Frame: These data is collected from the cases' medical record in an average of 1 month after the sample recruiting ]
  2. Gender for each participant [ Time Frame: These data is collected from the cases' medical record in an average of 1 month after the sample recruiting ]
  3. Height for each participant [ Time Frame: These data is collected from the cases' medical record in an average of 1 month after the sample recruiting ]
  4. Weight for each participant [ Time Frame: These data is collected from the cases' medical record in an average of 1 month after the sample recruiting ]
  5. Contact information for each participant [ Time Frame: These data is collected from the cases' medical record in an average of 1 month after the sample recruiting ]
  6. Past Medical History including disease history, surgical history, and family medical history [ Time Frame: These data is collected from the cases' medical record in an average of 1 month after the sample recruiting ]
  7. Lifestyle including smoking history and drinking, specify how many years smoking or drinking lasted and detail quantity per day [ Time Frame: These data is collected from the cases' medical record in an average of 1 month after the sample recruiting ]
  8. Exon sequencing data of each participant [ Time Frame: Sequencing will be carried out in an average of 3 months after sample recruiting ]
  9. Serum biomarker screening data of each participant [ Time Frame: Screening will be carried out in an average of 3 months after sample recruiting ]
  10. The location of Aneurysm/Dissection [ Time Frame: These data is collected from the cases' medical record in an average of 1 month after the sample recruiting ]
  11. The size of Aneurysm/Dissection [ Time Frame: These data is collected from the cases' medical record in an average of 1 month after the sample recruiting ]
  12. blood biochemical index:blood lipid [ Time Frame: These data is collected from the cases' medical record in an average of 1 month after the sample recruiting ]
  13. blood biochemical index:blood glucose [ Time Frame: These data is collected from the cases' medical record in an average of 1 month after the sample recruiting ]
  14. blood biochemical index:uric acid [ Time Frame: These data is collected from the cases' medical record in an average of 1 month after the sample recruiting ]
  15. blood biochemical index:urea [ Time Frame: These data is collected from the cases' medical record in an average of 1 month after the sample recruiting ]
  16. blood biochemical index:creatinine [ Time Frame: These data is collected from the cases' medical record in an average of 1 month after the sample recruiting ]
  17. blood biochemical index:C reactive protein [ Time Frame: These data is collected from the cases' medical record in an average of 1 month after the sample recruiting ]
  18. blood biochemical index:d dime [ Time Frame: These data is collected from the cases' medical record in an average of 1 month after the sample recruiting ]
  19. Drug treatment [ Time Frame: These data is collected from the cases' medical record in an average of 1 month after the sample recruiting ]
  20. Surgery type [ Time Frame: These data is collected from the cases' medical record in an average of 1 month after the sample recruiting ]
  21. Prognosis information: all-cause death [ Time Frame: These data is collected during follow-up visit at 3/6/12 months after discharge ]
  22. Prognosis information: whether recidivation happened [ Time Frame: These data is collected during follow-up visit at 3/6/12 months after discharge ]
  23. Prognosis information including: whether other related disease happened [ Time Frame: These data is collected during follow-up visit at 3/6/12 months after discharge ]

Biospecimen Retention:   Samples With DNA

If a blood specimen is obtained, it will be separated and stored at -80 ℃ as plasma, viable cells, and extracted DNA. If a saliva specimen is obtained, it is stored for DNA.

If a tissue specimen is obtained, it will be cut into small pieces and stored at liquid nitrogen.



Information from the National Library of Medicine

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Ages Eligible for Study:   up to 80 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
case group consists of patients who was diagnosed as thoracic aortic aneurysm/dissection; control group is general population without aortic aneurysm/dissection
Criteria

Case Inclusion Criteria:

  1. Subject who was diagnosed as thoracic aortic aneurysm/dissection by CT angiography, interventional angiography or vascular ultrasound;
  2. Age is less than 80 years old;
  3. male and non pregnancy female;
  4. Subject understands study requirements aand agrees to sign an informed consent form prior to any study procedures.

Case Exclusion Criteria:

Subject has one of the following:

  1. Pseudoaneurysm;
  2. Previous infection or trauma in the damaged part of aorta;
  3. Pregnancy female;
  4. Participate in other clinical trials in the last 1 months.

Control Inclusion Criteria:

  1. Age and gender are matched with cases;
  2. No aortic disease was detected by outpatient ultrasound;
  3. No family history of cardiovascular disease;
  4. Normal biochemical indicators;

Criteria for culling, shedding and suspension testing:

  1. Culling: Unqualified cases and controls. Data of culled subjects can not be used for statistical analysis;
  2. Shedding: Subject that self withdrawal, loss to follow-up, or quitted by doctors; Reasons for shedding should be indicated for each shed subject.
  3. Suspension: a) The researchers found significant safety problems or wrong study design; b) Researchers cannot continue clinical research due to funding or management reasons; c) Director ends the study. When suspension happens, all the CRF table should be reserved for future reference.

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): NCT03010514


Contacts
Contact: Yulin Li, PHD lyllyl_1111@163.com

Locations
China
Beijing Anzhen Hospital Recruiting
Beijing, China, 100029
Contact: ke-xu Yang    86-010-64426153    EC@anzhenGCP.com   
Sponsors and Collaborators
Beijing Institute of Heart, Lung and Blood Vessel Diseases
Investigators
Study Director: Jie Du, PHD Beijing Anzhen Hospital

Responsible Party: Beijing Institute of Heart, Lung and Blood Vessel Diseases
ClinicalTrials.gov Identifier: NCT03010514     History of Changes
Other Study ID Numbers: BeijingIHLBVD2016017
First Posted: January 5, 2017    Key Record Dates
Last Update Posted: January 5, 2017
Last Verified: January 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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