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Potential Biomarkers for Early Diagnosis of Acute Aortic Dissection

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ClinicalTrials.gov Identifier: NCT01860768
Recruitment Status : Unknown
Verified May 2013 by CHAI Xiangping, Central South University.
Recruitment status was:  Recruiting
First Posted : May 23, 2013
Last Update Posted : May 27, 2013
Sponsor:
Information provided by (Responsible Party):
CHAI Xiangping, Central South University

Brief Summary:

Acute aortic dissection (AAD) is an acute vascular lesions with high early misdiagnosis rate(31.8%), and mortality rate was 38%. In recent years, the incidence is rising and serious threat to human health. At present, the clinical diagnosis of AAD commonly used imaging methods, including chest X-ray, B ultrasound, CT, MRI and aortic angiography. Chest X-ray and two-dimensional ultrasound is limited in diagnosis of AAD, esophageal ultrasonography can display the intimal, identify the true and false lumen, but greater risk. CT, MRI and aortic angiography can be used as diagnosis method, but time-consuming, expensive and requires handling patients in emergency situations, should not be used as the preferred. Therefore, it is significance that biomarkers with high specificity and sensitivity for clinical fast diagnosis of AAD.

Parts small sample tests found that single serum α-smooth muscle actin (α-SMA), myosin heavy chain(MHC) and human soluble elastin fragments (sELAF) levels in patients with AAD were significantly higher than that of others (normal people, acute myocardial infarction patients). But because of the small study sample, limited control risk factors and incomplete comparison, their conclusions were questionable. In our previous studies also found that serum α-SMA, MHC and sELAF levels and the pathogenesis of AAD and prognosis are closely related. Therefore, on the basis, a prospective study is needed. We observe all the three biomarkers in enrolled patients with acute chest pain in emergency department, levels in healthy volunteers as the blank control. Then make definite diagnosis of the enrolled patients, and further observe the biomarkers dynamic change in AAD. Lastly, evaluate the early diagnostic value of combination serum α-SMA, MHC and sELAF level on patients with AAD.


Condition or disease
Aortic Dissection Biomarkers and Early Diagnosis

Detailed Description:

This is a prospective clinical study designed to procure blood samples from patients who present to the Emergency Department with suspected AAD.

Subjects enrolled in this study will sign and informed consent and have 3 blood samples drawn at different time points during their emergency department visit. In addition, data will be collected about the patient's health history, hospital procedures, and final diagnosis.

Blood samples collected in this study will be sent to laboratory for long-term storage and analysis in the future for these blood markers as they become available. No genetic testing will be conducted on these samples.


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Study Type : Observational
Estimated Enrollment : 200 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Potential Biomarkers for Early Diagnosis of Acute Aortic Dissection
Study Start Date : May 2013
Estimated Primary Completion Date : February 2014
Estimated Study Completion Date : April 2014

Group/Cohort
acute aortic dissectin patients
definite diagnosis by computed tomography arteriography (CTA).
acute chest pain patients
aortic dissection is exclude by aorta CTA



Primary Outcome Measures :
  1. Diagnostic accuracy(sensitivity and specificity of 400 participates for diagnosing acute aortic dissection) of serum biomarkers on patients with AAD. [ Time Frame: 1 day (Emergency room without follow-up) ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Alll patients presenting to the Second Xiangya Hospital of Central South Unversity Emergency Department with acute chest pain.
Criteria

Inclusion Criteria:

  • chest pain without diagnosis confirmed
  • symptom occurred in 2 hours
  • ≥18 years old
  • Can complete the base information
  • Able and willing to give written consent

Exclusion Criteria:

  • known AAD
  • known causes of acute chest pain such as tumour and trauma
  • pregnant or lactating female
  • Associated chronic inflammatory diseases

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01860768


Contacts
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Contact: CHAI Xiangping, MD +86-13787204259 fenghuaxuepiao@qq.com

Locations
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China, Hunan
The Second Xiangya Hospital of Central South University Recruiting
Changsha, Hunan, China, 410011
Contact: PENG Wen, Master       suiyuehuakai@qq.com   
Sponsors and Collaborators
Central South University

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Responsible Party: CHAI Xiangping, vice director of emergency department; vice director of hospital office, Central South University
ClinicalTrials.gov Identifier: NCT01860768     History of Changes
Other Study ID Numbers: 2XY-ED-001
First Posted: May 23, 2013    Key Record Dates
Last Update Posted: May 27, 2013
Last Verified: May 2013

Keywords provided by CHAI Xiangping, Central South University:
Acute aortic dissection
Serum biomarkers
Early diagnosis

Additional relevant MeSH terms:
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Aneurysm, Dissecting
Aneurysm
Vascular Diseases
Cardiovascular Diseases