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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00795249
First Posted: November 21, 2008
Last Update Posted: June 23, 2011
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Kurume University
  Purpose
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 Intervention Phase
Atherosclerosis Behavioral: smoking cessation Early Phase 1

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:


Further study details as provided by Kurume University:

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

Secondary Outcome Measures:
  • FMD [ Time Frame: 2 weeks ]

Enrollment: 100
Study Start Date: November 2008
Study Completion Date: November 2010
Primary Completion Date: November 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Information from the National Library of Medicine

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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)
  Contacts and Locations
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
  More Information

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 Submitted: November 20, 2008
First Posted: November 21, 2008
Last Update Posted: June 23, 2011
Last Verified: May 2010

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


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