Relation of Circulating Endothelium-derived Microparticle... | NCT00795067

Studies
Relation of Circulating Endothelium-derived Microparticle to Carotid Atherosclerosis

NCT00795067

Sponsor

Kurume University

Status

Completed

Last Update Posted

Mar 31, 2015Estimated

Enrollment

154Actual

Phase

Not provided

Conditions

Atherosclerosis

Interventions

Not provided

Countries

Japan

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Mar 2015

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Nov 2008

Primary Completion Date

Nov 2010Actual

Completion Date

Nov 2013Actual

First Submitted Date

Nov 20, 2008

First Submission Date that Met QC Criteria

Nov 20, 2008

First Posted Date

Nov 21, 2008Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 30, 2015

Last Update Posted Date

Mar 31, 2015Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

154Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Carotid atherosclerosis group		Patients who undergo carotid ultrasound examination for carotid atherosclerosis screening

Interventions

Not provided

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
The number of circulating EMPs		at the time of carotid ultrasound examination

Secondary Outcomes

Measure	Description	Time Frame
The occurrence of cerebrovascular and/or cardiovascular events		3 years

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

20 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Patients who undergo carotid ultrasound examination for screening of atheroscrelosis

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Tsutomu Imaizumi, MD, PhD	Kurume University	Study Chair

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Kurume University Hospital		Kurume	Fukuoka	830-0011	Japan

Condition Browse Module

MeSH Terms

ID	Term
D050197	Atherosclerosis

Ancestor Terms

ID	Term
D001161	Arteriosclerosis
D001157	Arterial Occlusive Diseases
D014652	Vascular Diseases
D002318	Cardiovascular Diseases

Browse Leaves

Not provided

Browse Branches

Not provided