Intraplaque Neovascularization Evaluated by Carotid Enhanced Ultrasound Well Reflect the Plaque Vulnerability Clinical Trial
Official title:
Can Serum Biomarker of Plaque Vulnerability be Identified Through the Contrast-enhanced Ultrasound of Carotid Artery
| Verified date | April 2013 |
| Source | Kyunghee University Medical Center |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | Korea: Food and Drug Administration |
| Study type | Observational |
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
| Status | Completed |
| Enrollment | 120 |
| Est. completion date | December 2013 |
| Est. primary completion date | October 2013 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | N/A and older |
| Eligibility |
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 |
Observational Model: Case Control, Time Perspective: Prospective
| Country | Name | City | State |
|---|---|---|---|
| Korea, Republic of | Division of Cardiology, Department of Internal Medicine, Kyung Hee University School of Medicine | Seoul |
| Lead Sponsor | Collaborator |
|---|---|
| Kyunghee University Medical Center |
Korea, Republic of,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | 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 | No | |
| Secondary | 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 | No |