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

This study has been completed.
Sponsor:
Information provided by:
Kurume University
ClinicalTrials.gov Identifier:
NCT00795249
First received: November 20, 2008
Last updated: June 22, 2011
Last verified: May 2010

November 20, 2008
June 22, 2011
November 2008
November 2010   (final data collection date for primary outcome measure)
The number of circulating EMP [ Time Frame: 2 weeks ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00795249 on ClinicalTrials.gov Archive Site
FMD [ Time Frame: 2 weeks ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Effects of Chronic Smoking on Circulating Endothelial and Platelet-derived Microparticle
Effects of Chronic Smoking on Circulating Endothelial and Platelet-derived Microparticle

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.

Not Provided
Interventional
Phase 0
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Screening
Atherosclerosis
Behavioral: smoking cessation
After baseline examination, the group is asked to quit smoking for 2 weeks.
  • Experimental: smoker
    Individuals who have a habit of chronic smoking without any coronary risk factors
    Intervention: Behavioral: smoking cessation
  • No Intervention: non-smoker
    the age-matched healthy volunteers
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
100
November 2010
November 2010   (final data collection date for primary outcome measure)

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)
Male
20 Years to 40 Years
Yes
Contact information is only displayed when the study is recruiting subjects
Japan
 
NCT00795249
KurumeU-08061
Yes
Tsutomu Imaizumi/Chair of Cardio-vascular Medicine Kurume University, Cardio-vascular Medicine Kurume University
Kurume University
Not Provided
Study Chair: Tsutomu Imaizumi, MD, PhD Kurume University
Kurume University
May 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP