NCT00795067

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
154

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Nov 2008

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2008

Completed
19 days until next milestone

First Submitted

Initial submission to the registry

November 20, 2008

Completed
1 day until next milestone

First Posted

Study publicly available on registry

November 21, 2008

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2010

Completed
3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2013

Completed
Last Updated

March 31, 2015

Status Verified

March 1, 2015

Enrollment Period

2 years

First QC Date

November 20, 2008

Last Update Submit

March 30, 2015

Conditions

Atherosclerosis

Outcome Measures

Primary Outcomes (1)

  • The number of circulating EMPs

    at the time of carotid ultrasound examination

Secondary Outcomes (1)

  • The occurrence of cerebrovascular and/or cardiovascular events

    3 years

Study Arms (1)

Carotid atherosclerosis group

Patients who undergo carotid ultrasound examination for carotid atherosclerosis screening

Eligibility Criteria

Age20 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients who undergo carotid ultrasound examination for screening of atheroscrelosis

You may qualify if:

  • Patients who undergo carotid ultrasound examination for screening of atherosclerosis

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kurume University Hospital

Kurume, Fukuoka, 830-0011, Japan

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

platelet-poor plasma whole blood urine

MeSH Terms

Conditions

Atherosclerosis

Condition Hierarchy (Ancestors)

ArteriosclerosisArterial Occlusive DiseasesVascular DiseasesCardiovascular Diseases

Study Officials

  • Tsutomu Imaizumi, MD, PhD

    Kurume University

    STUDY CHAIR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate professor of Medicine

Study Record Dates

First Submitted

November 20, 2008

First Posted

November 21, 2008

Study Start

November 1, 2008

Primary Completion

November 1, 2010

Study Completion

November 1, 2013

Last Updated

March 31, 2015

Record last verified: 2015-03

Locations

JP(1)