A Single-center Trial of Patients With Aortic Dissection... | NCT02378103

Studies
A Single-center Trial of Patients With Aortic Dissection in the Chinese XinJiang Province

NCT02378103

Sponsor

Xiang Ma

Status

Unknown status

Last Update Posted

Feb 4, 2016Estimated

Enrollment

100Estimated

Phase

Not provided

Conditions

Aortic Dissection

Interventions

Not provided

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Feb 2016

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Active, not recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Feb 2015

Primary Completion Date

Mar 2016Estimated

Completion Date

Aug 2016Estimated

First Submitted Date

Feb 14, 2015

First Submission Date that Met QC Criteria

Feb 27, 2015

First Posted Date

Mar 4, 2015Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Feb 3, 2016

Last Update Posted Date

Feb 4, 2016Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Xiang Ma, A Single-center Trial of Patients with Aortic Dissection in the Chinese XinJiang Province, First Affiliated Hospital of Xinjiang Medical UniversitySponsor-Investigator

Lead Sponsor

Xiang MaOTHER

Collaborators

Not provided

Description Module

Brief Summary

To evaluate epidemiological features of risk factors for aortic dissection (AD) in Chinese XinJiang Province patients.

Detailed Description

The epidemiological features of risk factors for aortic dissection (AD) in China were obtained from developed population in east of China, however, such information was not available for the remote population. Moreover, people in the western region have significant difference with developed population in lifestyle, diet, ethnic and so on. Therefore, the aim of our study was to evaluate epidemiological features of risk factors for AD in Chinese remote patients. We anticipated that this analysis would provide helpful information preventing and controlling AD in Chinese XinJiang Province.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

100Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Case		Diagnosis of aortic dissection was based on history and physical examination, and confirmed by imaging, visualization at surgery, and/or postmortem examination. Simple aortic aneurysm and pseudoaneurysm were excluded. Simple aortic aneurysm and pseudoaneurysm were excluded. Surgical and endovascular treatments were the main interventions and performed in the case group.
Control		As the control group, patients without AD were obtained from the hospitalized patients in the same period.

Interventions

Not provided

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Participants with related events for aortic dissection in Chinese XinJiang population		1 year

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Clinical diagnosis of aortic dissection
≥18 years old
good compliance with the instructions and cooperate with follow-up voluntarily signed the informed consent form

Exclusion Criteria:

pregnant or lactating female
bad compliance with the instructions and follow-up
estimated remaining life is less than 12 months
Aortic aneurysm、Acute Myocardial infarction、Acute Cerebral accident

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

80 Years

Standard Ages

AdultOlder Adult

Study Population

Between March, 2015 and March, 2016, we aim to collect 100 patients with AD as the case group. As the control group, 100 patients without AD were obtained from the hospitalized patients in the same period.

Sampling Method

Probability Sample

Condition Browse Module

MeSH Terms

ID	Term
D000784	Aortic Dissection

Ancestor Terms

ID	Term
D000094665	Dissection, Blood Vessel
D000783	Aneurysm
D014652	Vascular Diseases
D002318	Cardiovascular Diseases

Browse Leaves

Not provided

Browse Branches

Not provided