Significance of Serum Tenascin C in Patients With Acute Aortic Disease

Aortic Dissection Clinical Trial

Official title:

Significance of Serum Tenascin C in Patients With Acute Aortic Disease

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02816892
• Other study ID #: 2XY-ED-002
• Status: Recruiting
• Phase: N/A
• First received: April 25, 2016
• Last updated: June 25, 2016
• Start date: June 2016
• Est. completion date: December 2016

Study information

• Verified date: June 2016
• Source: Central South University
• Contact: Xiangping Chai, M.D.
• Phone: +86-13787204259
• Email: laochaicn[@]aliyun.com
• Is FDA regulated: No
• Health authority: China: National Natural Science Foundation
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: December 2016
• Est. primary completion date: December 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 90 Years

Eligibility

Inclusion Criteria:

• adults

• sudden severe thoracic or abdominal pain

Exclusion Criteria:

• lesser than 18 years

• pregnant women

• trauma

• tumour

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Aortic Diseases
• Aortic Dissection

Locations

Country	Name	City	State
China	The Second Xiangya Hospital of Central South University	Changsha	Hunan

Sponsors (1)

Lead Sponsor	Collaborator
Central South University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The level of serum tenascin-C	serum tenascin-C in ng/ml was measured by elasia	lesser than 48hours	Yes
Secondary	Characteristics of enrolled subjects	age in years,sex,IBM in kg/m^2 and associated history was collected	lesser than 48hours	Yes
Secondary	The level of D-D,C-reactive protein,elastic protein fragment	The level of D-D in ng/ml,C-reactive proteinin ng/ml,elastic protein fragmentin ng/ml was measured by elasia	lesser than 48hours	Yes