NCT00795249

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
100

participants targeted

Target at P75+ for early_phase_1

Timeline
Completed

Started Nov 2008

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

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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
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2010

Completed
Last Updated

June 23, 2011

Status Verified

May 1, 2010

Enrollment Period

2 years

First QC Date

November 20, 2008

Last Update Submit

June 22, 2011

Conditions

Atherosclerosis

Outcome Measures

Primary Outcomes (1)

  • The number of circulating EMP

    2 weeks

Secondary Outcomes (1)

  • FMD

    2 weeks

Study Arms (2)

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

smoking cessationBEHAVIORAL

After baseline examination, the group is asked to quit smoking for 2 weeks.

smoker

Eligibility Criteria

Age20 Years - 40 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • healthy individuals who have no coronary risk factors

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kurume University Hospital

Kurume, Fukuoka, 830-0011, Japan

Location

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
interventional
Phase
early phase 1
Allocation
RANDOMIZED
Masking
NONE
Purpose
SCREENING
Intervention Model
PARALLEL
Sponsor Type
OTHER

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, 2010

Last Updated

June 23, 2011

Record last verified: 2010-05

Locations

JP(1)