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

A Chinese Registry to Determine the Genetic Risk Factors and Serumal Biomarkers for Thoracic Aortic Aneurysm/Dissection

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

Study Overview

• Status: Unknown
• Conditions: Aneurysm, Dissecting; Aortic Aneurysm, Thoracic

• Study Type: Observational
• Enrollment (Anticipated): 600

Contacts and Locations

Study Locations

• China
  • Beijing, China, 100029
    • Recruiting
    • Beijing Anzhen Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: No older than 80 years (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• 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

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
case
control

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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

Collaborators and Investigators

• Sponsor: Beijing Institute of Heart, Lung and Blood Vessel Diseases

Study record dates

Study Major Dates

• Study Start: October 1, 2016
• Primary Completion (Anticipated): April 1, 2019
• Study Completion (Anticipated): October 1, 2019

Study Registration Dates

• First Submitted: December 21, 2016
• First Submitted That Met QC Criteria: January 3, 2017
• First Posted (Estimate): January 5, 2017

Study Record Updates

• Last Update Posted (Estimate): January 5, 2017
• Last Update Submitted That Met QC Criteria: January 3, 2017
• Last Verified: January 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Aortic Diseases; Aneurysm; Aneurysm, Dissecting; Aortic Aneurysm; Aortic Aneurysm, Thoracic
• Other Study ID Numbers: BeijingIHLBVD2016017

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED