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

NCT03010514 | Unknown DMC

• 1 other identifier: BeijingIHLBVD2016017
• Study Type: observational
• Target: 600
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Aortic Aneurysm, Thoracic; Aneurysm, Dissecting

Outcome Measures

Primary Outcomes (23)

• 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

Study Arms (2)

case

control

Eligibility Criteria

• Age: Up to 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• 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.

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

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

Study Sites (1)

Beijing Anzhen Hospital

Beijing, 100029, China

RECRUITING

Related Publications (1)

• Fang G, Tian Y, Huang S, Zhang X, Liu Y, Li Y, Du J, Gao S. KLF15 maintains contractile phenotype of vascular smooth muscle cells and prevents thoracic aortic dissection by interacting with MRTFB. J Biol Chem. 2024 May;300(5):107260. doi: 10.1016/j.jbc.2024.107260. Epub 2024 Apr 4.

  PMID: 38582447 DERIVED

Biospecimen

Retention: SAMPLES WITH DNA

If a blood specimen is obtained, it will be separated and stored at -80 ℃ as plasma, viable cells, and extracted DNA. If a saliva specimen is obtained, it is stored for DNA. If a tissue specimen is obtained, it will be cut into small pieces and stored at liquid nitrogen.

MeSH Terms

Conditions

Aortic Aneurysm, Thoracic; Aortic Dissection

Condition Hierarchy (Ancestors)

Aortic Aneurysm; Aneurysm; Vascular Diseases; Cardiovascular Diseases; Aortic Diseases; Dissection, Blood Vessel; Acute Aortic Syndrome

Study Officials

• Jie Du, PHD

  Beijing Anzhen Hospital

  STUDY DIRECTOR

Central Study Contacts

Yulin Li, PHD

CONTACT

lyllyl_1111@163.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 21, 2016
• First Posted: January 5, 2017
• Study Start: October 1, 2016
• Primary Completion: April 1, 2019
• Study Completion: October 1, 2019
• Last Updated: January 5, 2017

Record last verified: 2017-01

Locations

CN (1)