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Serum Biomarker of Plaque Vulnerability and Contrast Ultrasound of Carotid Artery

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01842490
First Posted: April 29, 2013
Last Update Posted: August 25, 2014
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Weon Kim, Kyunghee University Medical Center
March 23, 2013
April 29, 2013
August 25, 2014
May 2010
October 2013   (Final data collection date for primary outcome measure)
Peak plasma concentration of Biomarker that is statistically significant different according to the presence of intraplaque neovascularization on contrast enhanced ultrasound of carotid artery [ Time Frame: after performing contrast enhanced ultrasound of carotid artery, upto 3 hospital days ]
Same as current
Complete list of historical versions of study NCT01842490 on ClinicalTrials.gov Archive Site
the number of the patients with history of cardiovascular event including myocardial infarction, cerebral vascular event and peripheral arterial disease and the number of 1 year clinical outcome of cardiovascular event [ Time Frame: after performing contrast enhanced ultrasound of carotid artery, upto 1 year clinical follow up ]
Same as current
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Serum Biomarker of Plaque Vulnerability and Contrast Ultrasound of Carotid Artery
Can Serum Biomarker of Plaque Vulnerability be Identified Through the Contrast-enhanced Ultrasound of Carotid Artery
No serum biomarker has qualified for clinical use until now. However several biomarkers, especially markers of inflammatory or proteolytic activity seem to promising in the identification of vulnerable plaques. Moreover, recent study confirmed that contrast-enhanced ultrasound imaging(CEUS) can visualize intraplaque neovascularization and represent the plaque vulnerability. In this study we try to identify indicators through analysis of the relationship between plaque neovascularization seen by CEUS and well known biomarkers such as serum matrix metalloproteinase(MMP)-2, MMP-9, cathepsin family(L,S,V), cystatin C, lipoprotein phospholipase A2, and hs-crp
Not Provided
Observational
Observational Model: Case Control
Time Perspective: Prospective
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Retention:   Samples Without DNA
Description:
serum
Non-Probability Sample
The patients were selected from those who admitted due to chest pain and underwent carotid duplex ultrasound examination at KyungHee university medical center, Seoul, South Korea.
Intraplaque Neovascularization Evaluated by Carotid Enhanced Ultrasound Well Reflect the Plaque Vulnerability
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
120
December 2013
October 2013   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • patients with carotid plaques size more than 2mm by carotid ultrasound

Exclusion Criteria:

  • known allergy to albumin, or to the ultrasound contrast agent
  • the patients with history of carotid endarterectomy and carotid stent
  • acute myocardial infarction, cardiogenic shock
  • connective tissue disease and malignancy
  • creatinine clearance lower than 30ml/min and the history of dialysis
Sexes Eligible for Study: All
Child, Adult, Senior
No
Contact information is only displayed when the study is recruiting subjects
Korea, Republic of
 
 
NCT01842490
INCA
Yes
Not Provided
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Weon Kim, Kyunghee University Medical Center
Kyunghee University Medical Center
Not Provided
Not Provided
Kyunghee University Medical Center
April 2013