Division of Cardiology, Department of Internal Medicine, Kyung Hee University School of Medicine
Seoul, 130-872, South Korea
Completed
NCT Number: NCT01842490
Serum Biomarker of Plaque Vulnerability and Contrast 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
Completed
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Sex eligibility
All sexes
Study type
Observational
Primary location
Who can participate
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
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
Treatment and study plan
Primary outcomes
-
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 outcomes
-
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
Sponsors and collaborators
Lead sponsor
Kyunghee University Medical Center
Other
Registry information
Official study title
Can Serum Biomarker of Plaque Vulnerability be Identified Through the Contrast-enhanced Ultrasound of Carotid Artery
Important dates
- Study start
- 2010
- Primary completion
- 2013
- Study completion
- 2013
- First posted
- Apr 29, 2013
- Registry last updated
- Aug 25, 2014
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.