Significance of Serum Tenascin C in Patients With Acute Aortic Disease

NCT02816892 | Unknown DMC

• 1 other identifier: 2XY-ED-002
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Aortic Dissection

Keywords

aortic dissection; biomarkers; diagnosis

Outcome Measures

Primary Outcomes (1)

• The level of serum tenascin-C

  serum tenascin-C in ng/ml was measured by elasia

  lesser than 48hours

Secondary Outcomes (2)

• Characteristics of enrolled subjects

  lesser than 48hours

• The level of D-D，C-reactive protein，elastic protein fragment

  lesser than 48hours

Study Arms (5)

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

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

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

You may qualify if:

• adults
• sudden severe thoracic or abdominal pain

You may not qualify if:

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

Sponsors & Collaborators

• Central South University: lead

Study Sites (1)

The Second Xiangya Hospital of Central South University

Changsha, Hunan, 410011, China

RECRUITING

MeSH Terms

Conditions

Aortic Dissection; Disease

Condition Hierarchy (Ancestors)

Dissection, Blood Vessel; Aneurysm; Vascular Diseases; Cardiovascular Diseases; Acute Aortic Syndrome; Aortic Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Xiangping Chai, M.D.

  Second Xiangya Hospital of Central South University

  STUDY CHAIR

Central Study Contacts

Xiangping Chai, M.D.

CONTACT

+86-13787204259; laochaicn@aliyun.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Vice Director of emergency department，director of hospital office

Study Record Dates

• First Submitted: April 25, 2016
• First Posted: June 29, 2016
• Study Start: June 1, 2016
• Primary Completion: December 1, 2016
• Study Completion: December 1, 2016
• Last Updated: June 29, 2016

Record last verified: 2016-06

Data Sharing

• IPD Sharing: Will share

Locations

CN (1)