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

Beijing Institute of Heart, Lung and Blood Vessel Diseases

Status: Unknown

Conditions: Aortic Aneurysm, Thoracic; Aneurysm, Dissecting

Study type: Observational

Funder types: Other

Identifiers

NCT03010514

BeijingIHLBVD2016017

Details and patient eligibility

About

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

Enrollment: 600 estimated patients

Sex: All

Ages: Under 80 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion 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.

Trial design

600 participants in 2 patient groups

case

control