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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):
Hisashi Kai, Kurume University

Tracking Information
First Submitted Date November 20, 2008
First Posted Date November 21, 2008
Last Update Posted Date March 31, 2015
Study Start Date November 2008
Actual Primary Completion Date November 2010   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: November 20, 2008)
The number of circulating EMPs [ Time Frame: at the time of carotid ultrasound examination ]
Original Primary Outcome Measures Same as current
Change History Complete list of historical versions of study NCT00795067 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures
 (submitted: November 20, 2008)
The occurrence of cerebrovascular and/or cardiovascular events [ Time Frame: 3 years ]
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Relation of Circulating Endothelium-derived Microparticle to Carotid Atherosclerosis
Official Title Relation of Circulating Endothelium-derived Microparticle to Carotid Atherosclerosis
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.
Detailed Description Not Provided
Study Type Observational
Study Design Observational Model: Case-Only
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Retention:   Samples Without DNA
Description:
platelet-poor plasma whole blood urine
Sampling Method Non-Probability Sample
Study Population Patients who undergo carotid ultrasound examination for screening of atheroscrelosis
Condition Atherosclerosis
Intervention Not Provided
Study Groups/Cohorts Carotid atherosclerosis group
Patients who undergo carotid ultrasound examination for carotid atherosclerosis screening
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: March 30, 2015)
154
Original Estimated Enrollment
 (submitted: November 20, 2008)
200
Actual Study Completion Date November 2013
Actual Primary Completion Date November 2010   (Final data collection date for primary outcome measure)
Eligibility 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
Sex/Gender
Sexes Eligible for Study: All
Ages 20 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Japan
Removed Location Countries  
 
Administrative Information
NCT Number NCT00795067
Other Study ID Numbers KurumeU-08060
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Hisashi Kai, Kurume University
Study Sponsor Kurume University
Collaborators Not Provided
Investigators
Study Chair: Tsutomu Imaizumi, MD, PhD Kurume University
PRS Account Kurume University
Verification Date March 2015