Serum Biomarker of Plaque Vulnerability and Contrast Ultrasound of Carotid Artery

Completed

• Conditions: Intraplaque Neovascularization Evaluated by Carotid Enhanced Ultrasound Well Reflect the Plaque Vulnerability

• Registration Number: NCT01842490
• Lead Sponsor: Kyunghee University Medical Center

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2010-05
• Study First Submitted: 2013-03-23
• Status Verified: 2013-04
• Study First Submitted QC: 2013-04-24
• Study First Posted: 2013-04-29
• Primary Completion: 2013-10
• Study Completion: 2013-12
• Last Update Submitted: 2014-08-22
• Last Update Posted: 2014-08-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 120

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Peak plasma concentration of Biomarker that is statistically significant different according to the presence of intraplaque neovascularization on contrast enhanced ultrasound of carotid artery	after performing contrast enhanced ultrasound of carotid artery, upto 3 hospital days

Secondary Outcome Measures

Name	Time	Method
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	after performing contrast enhanced ultrasound of carotid artery, upto 1 year clinical follow up

Trial Locations

Locations (1)

Division of Cardiology, Department of Internal Medicine, Kyung Hee University School of Medicine; 🇰🇷 Seoul, Korea, Republic of