Aortic Aneurysm, Thoracic Clinical Trial
— ARSGBTAADOfficial 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
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. |
Observational Model: Cohort, Time Perspective: Retrospective
Country | Name | City | State |
---|---|---|---|
China | Beijing Anzhen Hospital | Beijing |
Lead Sponsor | Collaborator |
---|---|
Beijing Institute of Heart, Lung and Blood Vessel Diseases |
China,
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 |
Status | Clinical Trial | Phase | |
---|---|---|---|
Active, not recruiting |
NCT02777593 -
Evaluation of the GORE® TBE Device in the Treatment of Lesions of the Aortic Arch and Descending Thoracic Aorta, Zone 2
|
N/A | |
Completed |
NCT02876263 -
Noninvasive Neuromonitoring of Surgery of the Thoracic Aorta
|
N/A | |
Terminated |
NCT02538822 -
Risk of Rupture of Aneurysms of the Thoracic Ascending Aorta (ATA) From the Dynamic Imaging
|
N/A | |
Completed |
NCT04930172 -
TOtal tRansfemoral branCHed endovasCular tHoracoabdominal Aortic Repair Registry
|
||
Completed |
NCT03207568 -
RE-GENERATION: The Safety and Performance of the Relay Pro and Relay NBS Pro Stent-graft Devices in the European Union (EU)
|
N/A | |
Completed |
NCT02266342 -
GORE® TAG® Thoracic Endoprosthesis French Mandatory Registry
|
||
Completed |
NCT00757003 -
To Evaluate the Safety and Efficacy for GORE TAG Thoracic Endoprosthesis in the Treatment of Thoracic Aortic Disease
|
Phase 3 | |
Recruiting |
NCT03574311 -
Preoperative Intravenous Ferric Carboxymaltose and Placebo in the Treatment of Patients Undergoing Cardiac Surgery
|
Phase 4 | |
Suspended |
NCT03410420 -
Detection of Hypoxia in Human Thoracic Aorta Using Pimonidazole Hydrochloride
|
Phase 1 | |
Recruiting |
NCT05703893 -
Investigation of the Neurovegetative Pattern in Patients With Thoracic Aortic Aneurysms (TAA)
|
||
Enrolling by invitation |
NCT05800743 -
Evaluation of the GORE® Ascending Stent Graft
|
N/A | |
Completed |
NCT02253082 -
Vasculopathic Injury and Plasma as Endothelial Rescue - OCTAplas Trial (EudraCT no. 2014-000452-28)
|
Phase 4 | |
Recruiting |
NCT02323581 -
Endovascular Treatment of TAAA and Aortic Arch Aneurysms Using Fenestrated and Branched Stent Grafts
|
N/A | |
Active, not recruiting |
NCT03414866 -
Thoraflex Hybrid Post-Market Study
|
||
Recruiting |
NCT01985906 -
Safety and Efficacy of Multiple Overlapping Uncovered Stents for Pararenal Aortic Aneurysm Repair
|
N/A | |
Active, not recruiting |
NCT02818972 -
RelayPro Thoracic Stent-Graft in Subjects With Thoracic Aortic Aneurysms and Penetrating Atherosclerotic Ulcers
|
N/A | |
Completed |
NCT03479164 -
Development of Ultra-Low Dose CT Based Screening for Aortic Aneurysms
|
N/A | |
Completed |
NCT01775046 -
Valiant Thoracic Stent Graft With the Captivia Delivery System in the Treatment of Descending Thoracic Aortic Diseases (VALIANT CAPTIVIA France)
|
||
Recruiting |
NCT04814238 -
Minimally Invasive Aortic Root and Aorta surGery rEgistry
|
||
Completed |
NCT01756911 -
Evaluation of the Safety and Efficacy of the Multilayer Stent
|
N/A |