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

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ClinicalTrials.gov Identifier: NCT00795249
Recruitment Status : Completed
First Posted : November 21, 2008
Last Update Posted : June 23, 2011
Sponsor:
Information provided by:
Kurume University

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.

Condition or disease Intervention/treatment Phase
Atherosclerosis Behavioral: smoking cessation Early Phase 1

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Screening
Official Title: Effects of Chronic Smoking on Circulating Endothelial and Platelet-derived Microparticle
Study Start Date : November 2008
Primary Completion Date : November 2010
Study Completion Date : November 2010

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Experimental: smoker
Individuals who have a habit of chronic smoking without any coronary risk factors
Behavioral: smoking cessation
After baseline examination, the group is asked to quit smoking for 2 weeks.
No Intervention: non-smoker
the age-matched healthy volunteers



Primary Outcome Measures :
  1. The number of circulating EMP [ Time Frame: 2 weeks ]

Secondary Outcome Measures :
  1. FMD [ Time Frame: 2 weeks ]


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Ages Eligible for Study:   20 Years to 40 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00795249


Locations
Japan
Kurume University Hospital
Kurume, Fukuoka, Japan, 830-0011
Sponsors and Collaborators
Kurume University
Investigators
Study Chair: Tsutomu Imaizumi, MD, PhD Kurume University

Responsible Party: Tsutomu Imaizumi/Chair of Cardio-vascular Medicine Kurume University, Cardio-vascular Medicine Kurume University
ClinicalTrials.gov Identifier: NCT00795249     History of Changes
Other Study ID Numbers: KurumeU-08061
First Posted: November 21, 2008    Key Record Dates
Last Update Posted: June 23, 2011
Last Verified: May 2010

Additional relevant MeSH terms:
Atherosclerosis
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Cardiovascular Diseases