A Chinese Registry to Determine the Genetic Risk Factors and Serumal Biomarkers for Thoracic Aortic Aneurysm/Dissection
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 600
- 试验地点
- 1
- 主要终点
- Age for each participant
研究概览
简要总结
This is a national registry study to determine genetic risk factor and serial biomarkers of thoracic aortic aneurysm/dissection
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
入排标准
- 年龄范围
- — 至 80 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Subject who was diagnosed as thoracic aortic aneurysm/dissection by CT angiography, interventional angiography or vascular ultrasound;
- •Age is less than 80 years old;
- •male and non pregnancy female;
- •Subject understands study requirements aand agrees to sign an informed consent form prior to any study procedures.
排除标准
- •Subject has one of the following:
- •Pseudoaneurysm;
- •Previous infection or trauma in the damaged part of aorta;
- •Pregnancy female;
- •Participate in other clinical trials in the last 1 months.
- •Control Inclusion Criteria:
- •Age and gender are matched with cases;
- •No aortic disease was detected by outpatient ultrasound;
- •No family history of cardiovascular disease;
- •Normal biochemical indicators;
- •Criteria for culling, shedding and suspension testing:
- •Culling: Unqualified cases and controls. Data of culled subjects can not be used for statistical analysis;
- •Shedding: Subject that self withdrawal, loss to follow-up, or quitted by doctors; Reasons for shedding should be indicated for each shed subject.
- •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.
结局指标
主要结局
Age for each participant
时间窗: These data is collected from the cases' medical record in an average of 1 month after the sample recruiting
Prognosis information: all-cause death
时间窗: These data is collected during follow-up visit at 3/6/12 months after discharge
Gender for each participant
时间窗: These data is collected from the cases' medical record in an average of 1 month after the sample recruiting
Weight for each participant
时间窗: 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
时间窗: These data is collected from the cases' medical record in an average of 1 month after the sample recruiting
The location of Aneurysm/Dissection
时间窗: These data is collected from the cases' medical record in an average of 1 month after the sample recruiting
blood biochemical index：blood lipid
时间窗: These data is collected from the cases' medical record in an average of 1 month after the sample recruiting
blood biochemical index：blood glucose
时间窗: These data is collected from the cases' medical record in an average of 1 month after the sample recruiting
blood biochemical index：creatinine
时间窗: These data is collected from the cases' medical record in an average of 1 month after the sample recruiting
blood biochemical index：d dime
时间窗: These data is collected from the cases' medical record in an average of 1 month after the sample recruiting
Prognosis information including: whether other related disease happened
时间窗: These data is collected during follow-up visit at 3/6/12 months after discharge
Contact information for each participant
时间窗: 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
时间窗: These data is collected from the cases' medical record in an average of 1 month after the sample recruiting
blood biochemical index：uric acid
时间窗: These data is collected from the cases' medical record in an average of 1 month after the sample recruiting
Height for each participant
时间窗: These data is collected from the cases' medical record in an average of 1 month after the sample recruiting
Serum biomarker screening data of each participant
时间窗: Screening will be carried out in an average of 3 months after sample recruiting
blood biochemical index：urea
时间窗: 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
时间窗: These data is collected from the cases' medical record in an average of 1 month after the sample recruiting
Drug treatment
时间窗: These data is collected from the cases' medical record in an average of 1 month after the sample recruiting
Prognosis information: whether recidivation happened
时间窗: These data is collected during follow-up visit at 3/6/12 months after discharge
Exon sequencing data of each participant
时间窗: Sequencing will be carried out in an average of 3 months after sample recruiting
The size of Aneurysm/Dissection
时间窗: These data is collected from the cases' medical record in an average of 1 month after the sample recruiting
Surgery type
时间窗: These data is collected from the cases' medical record in an average of 1 month after the sample recruiting
次要结局
未报告次要终点