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

Aortic Aneurysm, Thoracic Clinical Trial

— ARSGBTAAD  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03010514
• Other study ID #: BeijingIHLBVD2016017
• Status: Recruiting
• Phase: N/A
• First received: December 21, 2016
• Last updated: January 3, 2017
• Start date: October 2016
• Est. completion date: October 2019

Study information

• Verified date: January 2017
• Source: Beijing Institute of Heart, Lung and Blood Vessel Diseases
• Contact: Yulin Li, PHD
• Email: lyllyl_1111[@]163.com
• Is FDA regulated: No
• Health authority: China: Ethics Committee
• Study type: Observational

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 600
• Est. completion date: October 2019
• Est. primary completion date: April 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: N/A to 80 Years

Eligibility

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 Design

Observational Model: Cohort, Time Perspective: Retrospective

Related Conditions & MeSH terms

• Aneurysm
• Aneurysm, Dissecting
• Aortic Aneurysm
• Aortic Aneurysm, Thoracic

Locations

Country	Name	City	State
China	Beijing Anzhen Hospital	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Beijing Institute of Heart, Lung and Blood Vessel Diseases

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Age for each participant		These data is collected from the cases' medical record in an average of 1 month after the sample recruiting	Yes
Primary	Gender for each participant		These data is collected from the cases' medical record in an average of 1 month after the sample recruiting	Yes
Primary	Height for each participant		These data is collected from the cases' medical record in an average of 1 month after the sample recruiting	Yes
Primary	Weight for each participant		These data is collected from the cases' medical record in an average of 1 month after the sample recruiting	Yes
Primary	Contact information for each participant		These data is collected from the cases' medical record in an average of 1 month after the sample recruiting	Yes
Primary	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	Yes
Primary	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	Yes
Primary	Exon sequencing data of each participant		Sequencing will be carried out in an average of 3 months after sample recruiting	Yes
Primary	Serum biomarker screening data of each participant		Screening will be carried out in an average of 3 months after sample recruiting	Yes
Primary	The location of Aneurysm/Dissection		These data is collected from the cases' medical record in an average of 1 month after the sample recruiting	Yes
Primary	The size of Aneurysm/Dissection		These data is collected from the cases' medical record in an average of 1 month after the sample recruiting	Yes
Primary	blood biochemical index:blood lipid		These data is collected from the cases' medical record in an average of 1 month after the sample recruiting	Yes
Primary	blood biochemical index:blood glucose		These data is collected from the cases' medical record in an average of 1 month after the sample recruiting	Yes
Primary	blood biochemical index:uric acid		These data is collected from the cases' medical record in an average of 1 month after the sample recruiting	Yes
Primary	blood biochemical index:urea		These data is collected from the cases' medical record in an average of 1 month after the sample recruiting	Yes
Primary	blood biochemical index:creatinine		These data is collected from the cases' medical record in an average of 1 month after the sample recruiting	Yes
Primary	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	Yes
Primary	blood biochemical index:d dime		These data is collected from the cases' medical record in an average of 1 month after the sample recruiting	Yes
Primary	Drug treatment		These data is collected from the cases' medical record in an average of 1 month after the sample recruiting	Yes
Primary	Surgery type		These data is collected from the cases' medical record in an average of 1 month after the sample recruiting	Yes
Primary	Prognosis information: all-cause death		These data is collected during follow-up visit at 3/6/12 months after discharge	Yes
Primary	Prognosis information: whether recidivation happened		These data is collected during follow-up visit at 3/6/12 months after discharge	Yes
Primary	Prognosis information including: whether other related disease happened		These data is collected during follow-up visit at 3/6/12 months after discharge	Yes