Aortic Aneurysm, ThoracicARSGBTAADNCT03010514
A Registry Study on Genetics and Biomarkers of Thoracic Aortic Aneurysm/Dissection
An observational study of Aortic Aneurysm, Thoracic and Aneurysm, Dissecting, run by Beijing Institute of Heart, Lung and Blood Vessel Diseases at 1 site in China.
Trial summary
This is a national registry study to determine genetic risk factor and serial biomarkers of thoracic aortic aneurysm/dissection Read more about this study
- Who is it for?
- Ages Up to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Aortic Aneurysm, Thoracic, Aneurysm, Dissecting
- How many people
- 600 participants
- Where
- 1 siteChina
- Study dates
- Oct 2016to Oct 2019
- Phase
- Observational
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 80 years
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: case group consists of patients who was diagnosed as thoracic aortic aneurysm/dissection; control group is general population without aortic aneurysm/dissection
Case Inclusion Criteria:
- 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.
Case Exclusion Criteria:
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.
Trial locations and contacts
1 site in 1 country.
Yulin Li, PHD contact
China1 site, 1 recruiting
- Recruiting
Beijing Anzhen Hospital
Beijing, 100029
ke-xu Yang, 86-010-64426153, EC@anzhenGCP.com
About this study
Official title: 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
- Conditions
- Aortic Aneurysm, Thoracic, Aneurysm, Dissecting
- Medical subject headings
- Aortic Aneurysm, Thoracic, Aortic Dissection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| case | Not described | |
| control | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Age for each participant
Measured: These data is collected from the cases' medical record in an average of 1 month after the sample recruiting
Gender for each participant
Measured: These data is collected from the cases' medical record in an average of 1 month after the sample recruiting
Height for each participant
Measured: These data is collected from the cases' medical record in an average of 1 month after the sample recruiting
Weight for each participant
Measured: These data is collected from the cases' medical record in an average of 1 month after the sample recruiting
Contact information for each participant
Measured: 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
Measured: 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
Measured: 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
Measured: Sequencing will be carried out in an average of 3 months after sample recruiting
Serum biomarker screening data of each participant
Measured: Screening will be carried out in an average of 3 months after sample recruiting
The location of Aneurysm/Dissection
Measured: These data is collected from the cases' medical record in an average of 1 month after the sample recruiting
The size of Aneurysm/Dissection
Measured: These data is collected from the cases' medical record in an average of 1 month after the sample recruiting
blood biochemical index：blood lipid
Measured: These data is collected from the cases' medical record in an average of 1 month after the sample recruiting
blood biochemical index：blood glucose
Measured: These data is collected from the cases' medical record in an average of 1 month after the sample recruiting
blood biochemical index：uric acid
Measured: These data is collected from the cases' medical record in an average of 1 month after the sample recruiting
blood biochemical index：urea
Measured: These data is collected from the cases' medical record in an average of 1 month after the sample recruiting
blood biochemical index：creatinine
Measured: 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
Measured: These data is collected from the cases' medical record in an average of 1 month after the sample recruiting
blood biochemical index：d dime
Measured: These data is collected from the cases' medical record in an average of 1 month after the sample recruiting
Drug treatment
Measured: These data is collected from the cases' medical record in an average of 1 month after the sample recruiting
Surgery type
Measured: These data is collected from the cases' medical record in an average of 1 month after the sample recruiting
Prognosis information: all-cause death
Measured: These data is collected during follow-up visit at 3/6/12 months after discharge
Prognosis information: whether recidivation happened
Measured: These data is collected during follow-up visit at 3/6/12 months after discharge
Prognosis information including: whether other related disease happened
Measured: These data is collected during follow-up visit at 3/6/12 months after discharge
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jan 2017 (estimated)
- Study startOct 2016
- Primary completionApr 2019 (estimated)
- Study completionOct 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Aortic Aneurysm, ThoracicStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 600 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Beijing Institute of Heart, Lung and Blood Vessel Diseases
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jie Du, PHD, Study director, Beijing Anzhen Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03010514
- Sponsor's protocol ID
- BeijingIHLBVD2016017
- Acronym
- ARSGBTAAD
- Status last verified
- Jan 2017
- First submitted
- 21 Dec 2016
- Last updated
- 5 Jan 2017
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided
Publications
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.
PubMed 38582447