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Serum Biomarker of Plaque Vulnerability and Contrast Ultrasound of Carotid Artery

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Weon Kim, Kyunghee University Medical Center
ClinicalTrials.gov Identifier:
NCT01842490
First received: March 23, 2013
Last updated: August 22, 2014
Last verified: April 2013
  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 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 ] [ Designated as safety issue: No ]

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 ] [ Designated as safety issue: No ]

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

Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: Weon Kim, Assoiciate Professor, Kyunghee University Medical Center
ClinicalTrials.gov Identifier: NCT01842490     History of Changes
Other Study ID Numbers: INCA
Study First Received: March 23, 2013
Last Updated: August 22, 2014
Health Authority: Korea: Food and Drug Administration

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

Additional relevant MeSH terms:
Neovascularization, Pathologic
Metaplasia
Pathologic Processes

ClinicalTrials.gov processed this record on November 25, 2014