Significance of Serum Tenascin C in Patients With Acute Aortic Disease

• Conditions: Aortic Dissection

• Registration Number: NCT02816892
• Lead Sponsor: Central South University

Brief Summary

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

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.

Study Timeline

• Study First Submitted: 2016-04-25
• Status Verified: 2016-06
• Study Start: 2016-06
• Study First Submitted QC: 2016-06-25
• Last Update Submitted: 2016-06-25
• Study First Posted: 2016-06-29
• Last Update Posted: 2016-06-29
• Primary Completion: 2016-12
• Study Completion: 2016-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

• adults
• sudden severe thoracic or abdominal pain

Exclusion Criteria

• lesser than 18 years
• pregnant women
• trauma
• tumour

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The level of serum tenascin-C	lesser than 48hours	serum tenascin-C in ng/ml was measured by elasia

Secondary Outcome Measures

Name	Time	Method
The level of D-D，C-reactive protein，elastic protein fragment	lesser than 48hours	The level of D-D in ng/ml，C-reactive proteinin ng/ml，elastic protein fragmentin ng/ml was measured by elasia
Characteristics of enrolled subjects	lesser than 48hours	age in years,sex,IBM in kg/m\^2 and associated history was collected

Trial Locations

Locations (1)

The Second Xiangya Hospital of Central South University; 🇨🇳 Changsha, Hunan, China