Significance of Serum Tenascin C in Patients With Acute Aortic Disease

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.

Study Overview

• Status: Unknown
• Conditions: Aortic Dissection

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 Type: Observational
• Enrollment (Anticipated): 100

Contacts and Locations

• Study Contact: Name: Xiangping Chai, M.D.; Phone Number: +86-13787204259; Email: laochaicn@aliyun.com

Study Locations

• China
  • Hunan
    • Changsha, Hunan, China, 410011
      • Recruiting
      • The second Xiangya Hospital of Central South University
      • Contact: Tao Guo, M.D.; Email: 447921730@qq.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 90 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Adult patients who were suspected acute aortic disease in emergency department of the second xiangya hospital.

Description

Inclusion Criteria:

• adults
• sudden severe thoracic or abdominal pain

Exclusion Criteria:

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

Study Plan

How is the study designed?

Number of groups / cohorts

5

Cohorts and Interventions

Group / Cohort
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.
Covert rupture group; Covert rupture was defined as an intramural haematoma without detection of free blood in the body cavities.
Acute dissection group; Acute dissection was defined when blood separating the layers of the aortic media was newly diagnosed.
Chronic dissection group; Chronic dissection was defined as the absence of any visible propagation of a known dissection compared to preexisting examinations.
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The level of serum tenascin-C	serum tenascin-C in ng/ml was measured by elasia	lesser than 48hours

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Characteristics of enrolled subjects	age in years,sex,IBM in kg/m^2 and associated history was collected	lesser than 48hours
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

Collaborators and Investigators

• Sponsor: Central South University
• Investigators: Study Chair: Xiangping Chai, M.D., Central South University

Study record dates

Study Major Dates

• Study Start: June 1, 2016
• Primary Completion (Anticipated): December 1, 2016
• Study Completion (Anticipated): December 1, 2016

Study Registration Dates

• First Submitted: April 25, 2016
• First Submitted That Met QC Criteria: June 25, 2016
• First Posted (Estimate): June 29, 2016

Study Record Updates

• Last Update Posted (Estimate): June 29, 2016
• Last Update Submitted That Met QC Criteria: June 25, 2016
• Last Verified: June 1, 2016

More Information

Terms related to this study

• Keywords: biomarkers; diagnosis; aortic dissection
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Aneurysm; Aneurysm, Dissecting; Aortic Diseases
• Other Study ID Numbers: 2XY-ED-002

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES