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Status unknownNCT02816892Updated Jun 29, 2016

Significance of Serum Tenascin C in Patients With Acute Aortic Disease

An observational study in Aortic Dissection, sponsored by Central South University. Status unknown at 1 site in China. Open to participants aged 18 Years to 90 Years. Per ClinicalTrials.gov, last updated 2016-06-29.

Sponsored by Central South University · Observational

The sponsor has not verified this record recently (last verified Jun 2016), so the status shown — last known as Recruiting — may be out of date.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
100
Ages
18 Years to 90 Years
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Aortic Dissection

Keywords

  • aortic dissection
  • biomarkers
  • diagnosis
03

In context

Aortic Dissection

386 studies on the registry are indexed under Aortic Dissection; 117 are open to participants now.

This study's planned enrollment of 100 is below the median of 183 across 180 observational studies indexed under Aortic Dissection.

Browse Aortic Dissection studies →

Lead sponsor

Central South University is the lead sponsor of 126 studies on the registry; 29 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 90 Years
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Probability sample

Study population

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

Inclusion criteria

  • adults
  • sudden severe thoracic or abdominal pain

Exclusion criteria

Exclusion Criteria:

  • lesser than 18 years
  • pregnant women
  • trauma
  • tumour
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
100 participants (estimated)
Patient registry
No

Groups and cohorts

  • 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

06

What researchers measure

Primary outcomes

  1. The level of serum tenascin-C

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

    Time frame: lesser than 48hours

Secondary outcomes

  1. Characteristics of enrolled subjects

    age in years,sex,IBM in kg/m\^2 and associated history was collected

    Time frame: lesser than 48hours

  2. 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

    Time frame: lesser than 48hours

07

Study locations

1 of 1 sites recruiting
  • The Second Xiangya Hospital of Central South University
    Changsha, Hunan 410011, China
    Recruiting
08

References and documents

Individual participant data

Plan to share: Yes

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 29, 2016, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT02816892
Lead sponsor
Central South University
Responsible party
CHAI Xiangping (Vice Director of emergency department,director of hospital office, Central South University) — Principal investigator
First posted
Jun 29, 2016
Start date
Jun 2016
Primary completion
Dec 2016 (estimated)
Completion
Dec 2016 (estimated)
Last update
Jun 29, 2016

Study contacts

Xiangping Chai, M.D.
Contact
laochaicn@aliyun.com
+86-13787204259
Xiangping Chai, M.D.
study chair · Central South University

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Jun 2016. You cannot join it, but the record below documents what was studied.

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