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NCT00795067 Clinical Trial

Relation of Circulating Endothelium-derived Microparticle to Carotid Atherosclerosis

Atherosclerosis Clinical Trial

Official title:
Relation of Circulating Endothelium-derived Microparticle to Carotid Atherosclerosis

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00795067
Other study ID # KurumeU-08060
Secondary ID
Status Completed
Phase N/A
First received November 20, 2008
Last updated March 30, 2015
Start date November 2008
Est. completion date November 2013

Study information
Verified date March 2015
Source Kurume University
Contact n/a
Is FDA regulated No
Health authority Japan: Ministry of Health, Labor and Welfare
Study type Observational

Clinical Trial Summary

The investigators hypothesized that circulating endothelium-derived microparticle (EMP) may be a useful surrogate marker of atherosclerosis and future episode of cerebrovascular events. Peripheral blood is drawn at the time of carotid ultrasound examination. Circulating EMPs are counted using flow-cytometry. The correlation among circulating EMP, ultrasound findings, and atherosclerotic risk factors are determined by multiple stepwise regression analysis. The prevalence of cerebrovascular events is also determined during 3-year follow-up period.

Recruitment information / eligibility
Status Completed
Enrollment 154
Est. completion date November 2013
Est. primary completion date November 2010
Accepts healthy volunteers No
Gender Both
Age group 20 Years and older
Eligibility Inclusion Criteria:

- Patients who undergo carotid ultrasound examination for screening of atherosclerosis

Exclusion Criteria:

- Cerebrovascular events within the last 12 months

- Acute coronary syndrome, coronary and peripheral intervention within the last 6 months

- Uncontrolled heart failure

- Other severe systemic diseases

Study Design

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

Locations
Country Name City State
Japan Kurume University Hospital Kurume Fukuoka

Sponsors (1)
Lead Sponsor Collaborator
Kurume University

Country where clinical trial is conducted

Japan, 

Outcome
Type Measure Description Time frame Safety issue
Primary The number of circulating EMPs at the time of carotid ultrasound examination No
Secondary The occurrence of cerebrovascular and/or cardiovascular events 3 years No
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