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Relation of Circulating Endothelium-derived Microparticle to Carotid Atherosclerosis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00795067
Recruitment Status : Completed
First Posted : November 21, 2008
Last Update Posted : March 31, 2015
Sponsor:
Information provided by (Responsible Party):

Study Description
Brief 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.

Condition or disease
Atherosclerosis

Study Design

Study Type : Observational
Actual Enrollment : 154 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Relation of Circulating Endothelium-derived Microparticle to Carotid Atherosclerosis
Study Start Date : November 2008
Primary Completion Date : November 2010
Study Completion Date : November 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Atherosclerosis
U.S. FDA Resources

Groups and Cohorts

Group/Cohort
Carotid atherosclerosis group
Patients who undergo carotid ultrasound examination for carotid atherosclerosis screening


Outcome Measures

Primary Outcome Measures :
  1. The number of circulating EMPs [ Time Frame: at the time of carotid ultrasound examination ]

Secondary Outcome Measures :
  1. The occurrence of cerebrovascular and/or cardiovascular events [ Time Frame: 3 years ]

Biospecimen Retention:   Samples Without DNA
platelet-poor plasma whole blood urine

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients who undergo carotid ultrasound examination for screening of atheroscrelosis
Criteria

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
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00795067


Locations
Japan
Kurume University Hospital
Kurume, Fukuoka, Japan, 830-0011
Sponsors and Collaborators
Kurume University
Investigators
Study Chair: Tsutomu Imaizumi, MD, PhD Kurume University
More Information

Responsible Party: Hisashi Kai, Associate professor of Medicine, Kurume University
ClinicalTrials.gov Identifier: NCT00795067     History of Changes
Other Study ID Numbers: KurumeU-08060
First Posted: November 21, 2008    Key Record Dates
Last Update Posted: March 31, 2015
Last Verified: March 2015

Additional relevant MeSH terms:
Atherosclerosis
Carotid Artery Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Cardiovascular Diseases
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases