Effects of Chronic Smoking on Circulating Endothelial and... | NCT00795249

Studies
Effects of Chronic Smoking on Circulating Endothelial and Platelet-derived Microparticle

NCT00795249

Sponsor

Kurume University

Status

Completed

Last Update Posted

Jun 23, 2011Estimated

Enrollment

100Actual

Phase

Early Phase 1

Conditions

Atherosclerosis

Interventions

smoking cessation

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

May 2010

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 2010Actual

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

Jun 22, 2011

Last Update Posted Date

Jun 23, 2011Estimated

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 EMP is a useful surrogate marker of early stage of endothelial damage. To determine the effects of chronic smoking on circulating EMP, from healthy volunteers who have habit of chronic smoking, peripheral blood is drawn at the time of flow-mediated dilatation (FMD) examination. Spot urine is also collected. Circulating EMPs are counted using flow-cytometry. After 2-week smoking cessation, the measurements were repeated.

Detailed Description

Not provided

Design Module

Study Type

Interventional

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

Early Phase 1

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

100Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
smoker	Experimental	Individuals who have a habit of chronic smoking without any coronary risk factors	Behavioral: smoking cessation
non-smoker	No Intervention	the age-matched healthy volunteers

Interventions

Name	Type	Description	Arm Group Labels	Other Names
smoking cessation	Behavioral	After baseline examination, the group is asked to quit smoking for 2 weeks.	smoker

Measure	Description	Time Frame
The number of circulating EMP		2 weeks

Measure	Description	Time Frame
FMD		2 weeks

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

healthy individuals who have no coronary risk factors

Exclusion Criteria:

hypertension
dyslipidemia
chronic kidney disease
liver dysfunction
obesity (BMI>25.0)
cerebrovascular disease
other severe systemic diseases (cancer, inflammatory diseases, etc)

Accepts Healthy Volunteers

Yes

Sex

Male

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

20 Years

Maximum Age

40 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

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