Clinical trial NCT03010514: A Registry Study on Genetics and Biomarkers of Thoracic Aortic Aneurysm/Dissection
Official title: A Chinese Registry to Determine the Genetic Risk Factors and Serumal Biomarkers for Thoracic Aortic Aneurysm/Dissection
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Aortic Aneurysm, Thoracic
Aneurysm, Dissecting
Lead sponsor: Beijing Institute of Heart, Lung and Blood Vessel Diseases
Sponsor class: OTHER
First posted: 2017-01-05
Enrollment: 600
Sex: ALL
Maximum age (years): 80
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: RETROSPECTIVE
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

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


Eligibility criteria: 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.

Primary outcomes:
measure: Age for each participant
timeFrame: These data is collected from the cases' medical record in an average of 1 month after the sample recruiting
measure: Gender for each participant
timeFrame: These data is collected from the cases' medical record in an average of 1 month after the sample recruiting
measure: Height for each participant
timeFrame: These data is collected from the cases' medical record in an average of 1 month after the sample recruiting
measure: Weight for each participant
timeFrame: These data is collected from the cases' medical record in an average of 1 month after the sample recruiting
measure: Contact information for each participant
timeFrame: These data is collected from the cases' medical record in an average of 1 month after the sample recruiting
measure: Past Medical History including disease history, surgical history, and family medical history
timeFrame: These data is collected from the cases' medical record in an average of 1 month after the sample recruiting
measure: Lifestyle including smoking history and drinking, specify how many years smoking or drinking lasted and detail quantity per day
timeFrame: These data is collected from the cases' medical record in an average of 1 month after the sample recruiting
measure: Exon sequencing data of each participant
timeFrame: Sequencing will be carried out in an average of 3 months after sample recruiting
measure: Serum biomarker screening data of each participant
timeFrame: Screening will be carried out in an average of 3 months after sample recruiting
measure: The location of Aneurysm/Dissection
timeFrame: These data is collected from the cases' medical record in an average of 1 month after the sample recruiting
measure: The size of Aneurysm/Dissection
timeFrame: These data is collected from the cases' medical record in an average of 1 month after the sample recruiting
measure: blood biochemical index：blood lipid
timeFrame: These data is collected from the cases' medical record in an average of 1 month after the sample recruiting
measure: blood biochemical index：blood glucose
timeFrame: These data is collected from the cases' medical record in an average of 1 month after the sample recruiting
measure: blood biochemical index：uric acid
timeFrame: These data is collected from the cases' medical record in an average of 1 month after the sample recruiting
measure: blood biochemical index：urea
timeFrame: These data is collected from the cases' medical record in an average of 1 month after the sample recruiting
measure: blood biochemical index：creatinine
timeFrame: These data is collected from the cases' medical record in an average of 1 month after the sample recruiting
measure: blood biochemical index：C reactive protein
timeFrame: These data is collected from the cases' medical record in an average of 1 month after the sample recruiting
measure: blood biochemical index：d dime
timeFrame: These data is collected from the cases' medical record in an average of 1 month after the sample recruiting
measure: Drug treatment
timeFrame: These data is collected from the cases' medical record in an average of 1 month after the sample recruiting
measure: Surgery type
timeFrame: These data is collected from the cases' medical record in an average of 1 month after the sample recruiting
measure: Prognosis information: all-cause death
timeFrame: These data is collected during follow-up visit at 3/6/12 months after discharge
measure: Prognosis information: whether recidivation happened
timeFrame: These data is collected during follow-up visit at 3/6/12 months after discharge
measure: Prognosis information including: whether other related disease happened
timeFrame: These data is collected during follow-up visit at 3/6/12 months after discharge
Secondary outcomes:
Other outcomes:
Locations:
city: Beijing
country: China
facility: Beijing Anzhen Hospital
Study officials:
affiliation: Beijing Anzhen Hospital
name: Jie Du, PHD
role: STUDY_DIRECTOR
References: