Relation of Circulating Endothelium-derived Microparticle to Carotid Atherosclerosis

The recruitment status of this study is unknown because the information has not been verified recently.
Verified May 2010 by Kurume University.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Kurume University
ClinicalTrials.gov Identifier:
NCT00795067
First received: November 20, 2008
Last updated: June 22, 2011
Last verified: May 2010
  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

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Relation of Circulating Endothelium-derived Microparticle to Carotid Atherosclerosis

Resource links provided by NLM:


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

platelet-poor plasma whole blood urine


Estimated Enrollment: 200
Study Start Date: November 2008
Estimated Study Completion Date: November 2013
Primary Completion Date: November 2010 (Final data collection date for primary outcome measure)
Groups/Cohorts
Carotid atherosclerosis group
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
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

No publications provided

Responsible Party: Tsutomu Imaizumi/Chair of Cardio-vascular Medicine Kurume University, Cardio-vascular Medicine Kurume University
ClinicalTrials.gov Identifier: NCT00795067     History of Changes
Other Study ID Numbers: KurumeU-08060
Study First Received: November 20, 2008
Last Updated: June 22, 2011
Health Authority: Japan: Ministry of Health, Labor and Welfare

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

ClinicalTrials.gov processed this record on October 23, 2014