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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
  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
Phase 0

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • FMD [ Time Frame: 2 weeks ] [ Designated as safety issue: No ]

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

Ages Eligible for Study:   20 Years to 40 Years
Genders 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

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
Study First Received: November 20, 2008
Last Updated: June 22, 2011
Health Authority: Japan: Ministry of Health, Labor and Welfare

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

ClinicalTrials.gov processed this record on November 20, 2014