Significance of Serum Tenascin C in Patients With Acute Aortic Disease

NCT ID: NCT02816892

Last Updated: 2016-06-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

100 participants

Study Classification

OBSERVATIONAL

Study Start Date

2016-06-30

Study Completion Date

2016-12-31

Brief Summary

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This study aims to investigate Serum Tenascin C levels in patients with acute symptoms relating to a known or newly diagnosed aortic aneurysm in emergency department and reveals the possible role of Tenascin C in the development of the disease.

Detailed Description

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Patients with acute and chronic aortic disease /survivors and non-survivors were compared. Further subgroup analysis on the characteristics of the aneurysm and patients were performed. The aneurysms (ruptured and dissected) were divided according to the style of the Stanford classification,according to the location of the pathology in aneurysms of the ascending thoracic aorta .the descending thoracic aorta, or the abdominal aorta.The subgroup were divided according to the extent of propagation of the disease (rupture,covered rupture, acute dissection, chronic dissection and ectasia). Rupture was defined by direct visualisation of the discontinuity of the aortic wall by computed tomography, sonography, intraoperative findings or at autopsy with detection of blood in the pleural, pericardial or abdominal cavity. Covert rupture was defined as an intramural haematoma without detection of free blood in the body cavities. Acute dissection was defined when blood separating the layers of the aortic media was newly diagnosed. Chronic dissection was defined as the absence of any visible propagation of a known dissection compared to preexisting examinations. Ectatic aneurysm was defined as a permanent localised dilatation of the aorta with a diameter of at least 50% greater than normal. Documentation of the surgical interventions and autopsy reports was used to confirm the diagnosis. In all patients the investigators collected the history, age of the patients, duration of pain, blood pressure at admission and laboratory parameters (haematocrit, creatinine) and Tenascin C Serum levels after admission to our emergency department immediately. The patients were followed up until hospital discharge and the outcome (survived/died) was recorded.

Conditions

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Aortic Dissection

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Rupture group

Rupture was defined by direct visualisation of the discontinuity of the aortic wall by computed tomography, sonography, intraoperative findings or at autopsy with detection of blood in the pleural, pericardial or abdominal cavity.

No interventions assigned to this group

Covert rupture group

Covert rupture was defined as an intramural haematoma without detection of free blood in the body cavities.

No interventions assigned to this group

Acute dissection group

Acute dissection was defined when blood separating the layers of the aortic media was newly diagnosed.

No interventions assigned to this group

Chronic dissection group

Chronic dissection was defined as the absence of any visible propagation of a known dissection compared to preexisting examinations.

No interventions assigned to this group

Ectatic aneurysm group

Ectatic aneurysm was defined as a permanent localised dilatation of the aorta with a diameter of at least 50% greater than normal

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

* adults
* sudden severe thoracic or abdominal pain

Exclusion Criteria

* lesser than 18 years
* pregnant women
* trauma
* tumour
Minimum Eligible Age

18 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Central South University

OTHER

Sponsor Role lead

Responsible Party

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CHAI Xiangping

Vice Director of emergency department,director of hospital office

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Xiangping Chai, M.D.

Role: STUDY_CHAIR

Second Xiangya Hospital of Central South University

Locations

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The Second Xiangya Hospital of Central South University

Changsha, Hunan, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Xiangping Chai, M.D.

Role: CONTACT

+86-13787204259

Facility Contacts

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Tao Guo, M.D.

Role: primary

Other Identifiers

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2XY-ED-002

Identifier Type: -

Identifier Source: org_study_id

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