- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00795067
Relation of Circulating Endothelium-derived Microparticle to Carotid Atherosclerosis
March 30, 2015 updated by: Hisashi Kai, Kurume University
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.
Study Overview
Status
Completed
Conditions
Study Type
Observational
Enrollment (Actual)
154
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Fukuoka
-
Kurume, Fukuoka, Japan, 830-0011
- Kurume University Hospital
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
20 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
Patients who undergo carotid ultrasound examination for screening of atheroscrelosis
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
---|
Carotid atherosclerosis group
Patients who undergo carotid ultrasound examination for carotid atherosclerosis screening
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
The number of circulating EMPs
Time Frame: at the time of carotid ultrasound examination
|
at the time of carotid ultrasound examination
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
The occurrence of cerebrovascular and/or cardiovascular events
Time Frame: 3 years
|
3 years
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Chair: Tsutomu Imaizumi, MD, PhD, Kurume University
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
November 1, 2008
Primary Completion (Actual)
November 1, 2010
Study Completion (Actual)
November 1, 2013
Study Registration Dates
First Submitted
November 20, 2008
First Submitted That Met QC Criteria
November 20, 2008
First Posted (Estimate)
November 21, 2008
Study Record Updates
Last Update Posted (Estimate)
March 31, 2015
Last Update Submitted That Met QC Criteria
March 30, 2015
Last Verified
March 1, 2015
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- KurumeU-08060
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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