Relation of Circulating Endothelium-Derived Microparticle to Carotid Atherosclerosis - Full Text View

Sponsored by:	Kurume University
Information provided by:	Kurume University
ClinicalTrials.gov Identifier:	NCT00795067

Purpose

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
Atherosclerosis

U.S. FDA Resources

Study Type:	Observational
Study Design:	Case-Only, Prospective
Official Title:	Relation of Circulating Endothelium-Derived Microparticle to Carotid Atherosclerosis

Further study details as provided by Kurume University:

Primary Outcome Measures:

The number of circulating EMPs [ Time Frame: at the time of carotid ultrasound examination ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

The occurrence of cerebrovascular and/or cardiovascular events [ Time Frame: 3 years ] [ Designated as safety issue: No ]

Biospecimen Retention: Samples Without DNA

Biospecimen Description:

platelet-poor plasma whole blood urine

Estimated Enrollment:	200
Study Start Date:	November 2008
Estimated Study Completion Date:	November 2013
Estimated Primary Completion Date:	November 2010 (Final data collection date for primary outcome measure)

Groups/Cohorts
1 Patients who undergo carotid ultrasound examination for carotid atherosclerosis screening

Eligibility

Ages Eligible for Study:	20 Years and older
Genders Eligible for Study:	Both
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

Please refer to this study by its ClinicalTrials.gov identifier: NCT00795067

Contacts

Contact: Hisashi Kai, MD, PhD	+81-942-31-7562	naikai@med.kurume-u.ac.jp
Contact: Takahiro Anegawa, MD	+81-942-31-7667	anegawa_takahiro@kurume-u.ac.jp

Locations

Japan, Fukuoka
Kurume University Hospital	Recruiting
Kurume, Fukuoka, Japan, 830-0011
Contact: Hisashi Kai, MD, PhD +81-942-31-7562 naikai@med.kurume-u.ac.jp
Contact: Takahiro Anegawa, MD +81-942-31-7562 angawa_takahiro@kurume-u.ac.jp
Principal Investigator: Hisashi Kai, MD, PhD

Sponsors and Collaborators

Kurume University

Investigators

Study Chair:

Tsutomu Imaizumi, MD, PhD

Kurume University

More Information

Responsible Party:	Cardio-vascular Medicine Kurume University ( Tsutomu Imaizumi/Chair of Cardio-vascular Medicine Kurume University )
Study ID Numbers:	KurumeU-08060
Study First Received:	November 20, 2008
Last Updated:	November 20, 2008
ClinicalTrials.gov Identifier:	NCT00795067
Health Authority:	Japan: Ministry of Health, Labor and Welfare

Study placed in the following topic categories:

Arterial Occlusive Diseases
Atherosclerosis
Vascular Diseases
Central Nervous System Diseases

Arteriosclerosis
Brain Diseases
Carotid Artery Diseases
Cerebrovascular Disorders

Additional relevant MeSH terms:

Nervous System Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on January 14, 2009