Clinical trial NCT02816892: Significance of Serum Tenascin C in Patients With Acute Aortic Disease
Official title: Significance of Serum Tenascin C in Patients With Acute Aortic Disease
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Aortic Dissection
Keywords: aortic dissection
biomarkers
diagnosis
Lead sponsor: Central South University
Sponsor class: OTHER
First posted: 2016-06-29
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Adult patients who were suspected acute aortic disease in emergency department of the second xiangya hospital.

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.

Eligibility criteria: Inclusion Criteria:

* adults
* sudden severe thoracic or abdominal pain

Exclusion Criteria:

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

Primary outcomes:
measure: The level of serum tenascin-C
timeFrame: lesser than 48hours
Secondary outcomes:
measure: Characteristics of enrolled subjects
timeFrame: lesser than 48hours
measure: The level of D-D，C-reactive protein，elastic protein fragment
timeFrame: lesser than 48hours
Other outcomes:
Locations:
city: Changsha
country: China
facility: The Second Xiangya Hospital of Central South University
state: Hunan
Study officials:
affiliation: Central South University
name: Xiangping Chai, M.D.
role: STUDY_CHAIR
References: