Serum Biomarker of Plaque Vulnerability and Contrast Ultrasound of Carotid Artery

This study is currently recruiting participants.
Verified April 2013 by Kyunghee University Medical Center
Sponsor:
Information provided by (Responsible Party):
Weon Kim, Kyunghee University Medical Center
ClinicalTrials.gov Identifier:
NCT01842490
First received: March 23, 2013
Last updated: April 24, 2013
Last verified: April 2013

March 23, 2013
April 24, 2013
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 ] [ Designated as safety issue: No ]
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 ] [ Designated as safety issue: No ]
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

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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.
 
Recruiting
120
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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
Both
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No
Contact: Weon Kim, MD, PhD +82-2-958-8167 mylovekw@hanmail.net
Korea, Republic of
 
NCT01842490
INCA
Yes
Weon Kim, Kyunghee University Medical Center
Kyunghee University Medical Center
Not Provided
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Kyunghee University Medical Center
April 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP