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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
  Purpose
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

Condition
Intraplaque Neovascularization Evaluated by Carotid Enhanced Ultrasound Well Reflect the Plaque Vulnerability

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Prospective
Official Title: Can Serum Biomarker of Plaque Vulnerability be Identified Through the Contrast-enhanced Ultrasound of Carotid Artery

Resource links provided by NLM:


Further study details as provided by Weon Kim, Kyunghee University Medical Center:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Biospecimen Retention:   Samples Without DNA
serum

Estimated Enrollment: 120
Study Start Date: May 2010
Study Completion Date: December 2013
Primary Completion Date: October 2013 (Final data collection date for primary outcome measure)
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
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.
Criteria

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
  Contacts and Locations
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): NCT01842490


Locations
Korea, Republic of
Division of Cardiology, Department of Internal Medicine, Kyung Hee University School of Medicine
Seoul, Korea, Republic of, 130-872
Sponsors and Collaborators
Kyunghee University Medical Center
  More Information

Responsible Party: Weon Kim, Assoiciate Professor, Kyunghee University Medical Center
ClinicalTrials.gov Identifier: NCT01842490     History of Changes
Other Study ID Numbers: INCA
First Submitted: March 23, 2013
First Posted: April 29, 2013
Last Update Posted: August 25, 2014
Last Verified: April 2013

Keywords provided by Weon Kim, Kyunghee University Medical Center:
Biomarker
Carotid enhanced ultrasound
Intraplaque neovascularization

Additional relevant MeSH terms:
Neovascularization, Pathologic
Metaplasia
Pathologic Processes