ARSGBTAAD: A Registry Study on Genetics and Biomarkers of Thoracic Aortic Aneurysm/Dissection
Study Details
Study Description
Brief Summary
This is a national registry study to determine genetic risk factor and serial biomarkers of thoracic aortic aneurysm/dissection
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
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Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
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| case
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| control
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Outcome Measures
Primary Outcome Measures
- Age for each participant [These data is collected from the cases' medical record in an average of 1 month after the sample recruiting]
- Gender for each participant [These data is collected from the cases' medical record in an average of 1 month after the sample recruiting]
- Height for each participant [These data is collected from the cases' medical record in an average of 1 month after the sample recruiting]
- Weight for each participant [These data is collected from the cases' medical record in an average of 1 month after the sample recruiting]
- Contact information for each participant [These data is collected from the cases' medical record in an average of 1 month after the sample recruiting]
- Past Medical History including disease history, surgical history, and family medical history [These data is collected from the cases' medical record in an average of 1 month after the sample recruiting]
- Lifestyle including smoking history and drinking, specify how many years smoking or drinking lasted and detail quantity per day [These data is collected from the cases' medical record in an average of 1 month after the sample recruiting]
- Exon sequencing data of each participant [Sequencing will be carried out in an average of 3 months after sample recruiting]
- Serum biomarker screening data of each participant [Screening will be carried out in an average of 3 months after sample recruiting]
- The location of Aneurysm/Dissection [These data is collected from the cases' medical record in an average of 1 month after the sample recruiting]
- The size of Aneurysm/Dissection [These data is collected from the cases' medical record in an average of 1 month after the sample recruiting]
- blood biochemical index：blood lipid [These data is collected from the cases' medical record in an average of 1 month after the sample recruiting]
- blood biochemical index：blood glucose [These data is collected from the cases' medical record in an average of 1 month after the sample recruiting]
- blood biochemical index：uric acid [These data is collected from the cases' medical record in an average of 1 month after the sample recruiting]
- blood biochemical index：urea [These data is collected from the cases' medical record in an average of 1 month after the sample recruiting]
- blood biochemical index：creatinine [These data is collected from the cases' medical record in an average of 1 month after the sample recruiting]
- blood biochemical index：C reactive protein [These data is collected from the cases' medical record in an average of 1 month after the sample recruiting]
- blood biochemical index：d dime [These data is collected from the cases' medical record in an average of 1 month after the sample recruiting]
- Drug treatment [These data is collected from the cases' medical record in an average of 1 month after the sample recruiting]
- Surgery type [These data is collected from the cases' medical record in an average of 1 month after the sample recruiting]
- Prognosis information: all-cause death [These data is collected during follow-up visit at 3/6/12 months after discharge]
- Prognosis information: whether recidivation happened [These data is collected during follow-up visit at 3/6/12 months after discharge]
- Prognosis information including: whether other related disease happened [These data is collected during follow-up visit at 3/6/12 months after discharge]
Eligibility Criteria
Criteria
Case Inclusion Criteria:
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Subject who was diagnosed as thoracic aortic aneurysm/dissection by CT angiography, interventional angiography or vascular ultrasound;
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Age is less than 80 years old;
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male and non pregnancy female;
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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:
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Pseudoaneurysm;
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Previous infection or trauma in the damaged part of aorta;
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Pregnancy female;
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Participate in other clinical trials in the last 1 months.
Control Inclusion Criteria:
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Age and gender are matched with cases;
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No aortic disease was detected by outpatient ultrasound;
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No family history of cardiovascular disease;
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Normal biochemical indicators;
Criteria for culling, shedding and suspension testing:
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Culling: Unqualified cases and controls. Data of culled subjects can not be used for statistical analysis;
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Shedding: Subject that self withdrawal, loss to follow-up, or quitted by doctors; Reasons for shedding should be indicated for each shed subject.
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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.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Beijing Anzhen Hospital | Beijing | China | 100029 |
Sponsors and Collaborators
- Beijing Institute of Heart, Lung and Blood Vessel Diseases
Investigators
- Study Director: Jie Du, PHD, Beijing Anzhen Hospital
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- BeijingIHLBVD2016017