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
- Are there results?
- None posted in the registry
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
Study at a glance
From the registry record, last updated by the sponsor on 5 Jan 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Chinese Registry to Determine the Genetic Risk Factors and Serumal Biomarkers for Thoracic Aortic Aneurysm/Dissection
- ClinicalTrials.gov ID
- NCT03010514
- Acronym / sponsor ID
- ARSGBTAAD / BeijingIHLBVD2016017
- Conditions
- Aortic Aneurysm, Thoracic, Aneurysm, Dissecting
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 600 participants (estimated)
- Lead sponsor
- Beijing Institute of Heart, Lung and Blood Vessel DiseasesUniversity, hospital or other
- Study start
- Oct 2016
- Primary completion
- Apr 2019 (estimated)
- Study completion
- Oct 2019 (estimated)
- First posted
- 5 Jan 2017 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a national registry study to determine genetic risk factor and serial biomarkers of thoracic aortic aneurysm/dissection
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| case | – | – |
| control | – | – |
Who may qualify
- Ages
- Up to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Age for each participant
Time frame: These data is collected from the cases' medical record in an average of 1 month after the sample recruiting
Gender for each participant
Time frame: These data is collected from the cases' medical record in an average of 1 month after the sample recruiting
Height for each participant
Time frame: These data is collected from the cases' medical record in an average of 1 month after the sample recruiting
Weight for each participant
Time frame: These data is collected from the cases' medical record in an average of 1 month after the sample recruiting
Contact information for each participant
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: Sequencing will be carried out in an average of 3 months after sample recruiting
Serum biomarker screening data of each participant
Time frame: Screening will be carried out in an average of 3 months after sample recruiting
The location of Aneurysm/Dissection
Time frame: These data is collected from the cases' medical record in an average of 1 month after the sample recruiting
The size of Aneurysm/Dissection
Time frame: These data is collected from the cases' medical record in an average of 1 month after the sample recruiting
blood biochemical index：blood lipid
Time frame: These data is collected from the cases' medical record in an average of 1 month after the sample recruiting
blood biochemical index：blood glucose
Time frame: These data is collected from the cases' medical record in an average of 1 month after the sample recruiting
blood biochemical index：uric acid
Time frame: These data is collected from the cases' medical record in an average of 1 month after the sample recruiting
blood biochemical index：urea
Time frame: These data is collected from the cases' medical record in an average of 1 month after the sample recruiting
blood biochemical index：creatinine
Time frame: 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
Time frame: These data is collected from the cases' medical record in an average of 1 month after the sample recruiting
blood biochemical index：d dime
Time frame: These data is collected from the cases' medical record in an average of 1 month after the sample recruiting
Drug treatment
Time frame: These data is collected from the cases' medical record in an average of 1 month after the sample recruiting
Surgery type
Time frame: These data is collected from the cases' medical record in an average of 1 month after the sample recruiting
Prognosis information: all-cause death
Time frame: These data is collected during follow-up visit at 3/6/12 months after discharge
Prognosis information: whether recidivation happened
Time frame: These data is collected during follow-up visit at 3/6/12 months after discharge
Prognosis information including: whether other related disease happened
Time frame: These data is collected during follow-up visit at 3/6/12 months after discharge
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jan 2017.
- Derived from this study: PubMed 38582447Fang 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Yulin Li, PHD contact
Jie Du, PHD study director
Beijing Anzhen Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
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.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 5 Jan 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Yulin Li, PHD (lyllyl_1111@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Age for each participant (time frame: These data is collected from the cases' medical record in an average of 1 month after the sample recruiting). The study lists 23 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03010514, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Jan 2017.