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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT03010514
Other study ID # BeijingIHLBVD2016017
Secondary ID
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


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
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