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Effect of Passive Smoking on Platelet Function and Endothelial Function

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ClinicalTrials.gov Identifier: NCT00923988
Recruitment Status : Completed
First Posted : June 18, 2009
Last Update Posted : August 11, 2009
Sponsor:
Information provided by:
Kantonsspital Graubünden

Tracking Information
First Submitted Date  ICMJE June 17, 2009
First Posted Date  ICMJE June 18, 2009
Last Update Posted Date August 11, 2009
Study Start Date  ICMJE June 2009
Actual Primary Completion Date August 2009   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 17, 2009)
Change in platelet aggregation and/or endothelial function [ Time Frame: 12-24 hours ]
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT00923988 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Effect of Passive Smoking on Platelet Function and Endothelial Function
Official Title  ICMJE Acute Effects of Short-term Exposure to Secondhand Smoke on Platelet Activation and Endothelial Function
Brief Summary Passive smoking is associated with an increased risk for cardiovascular events. However, the exact mechanisms by which passive smoking affects cardiovascular health are not entirely understood. In the present study, the researchers investigate the effects of short-term exposure to secondhand smoke on platelet function and peripheral microvascular endothelial function in healthy individuals. For this purpose, platelet function and endothelial function are measured before and after a 1-hour exposure to secondhand smoke in a concentration that is encountered in bars and restaurants without smoke-free policies. The researchers' hypothesis is that short-term exposure leads to platelet activation and impairment of endothelial function.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Condition  ICMJE
  • Endothelial Function
  • Platelet Aggregation
Intervention  ICMJE Other: secondhand smoke exposure
Participants will be exposed to secondhand smoke for one hour. As a measure of secondhand smoke exposition, room carbon monoxide concentration will be continuously measured using an Ambient Carbon Monoxide Monitor APMA-360 and kept constant between 4.5-6.0 ppm. Levels in this magnitude are typically seen in smoking areas of restaurants and bars.
Study Arms  ICMJE Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Estimated Enrollment  ICMJE
 (submitted: June 17, 2009)
40
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE August 2009
Actual Primary Completion Date August 2009   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • healthy individuals
  • nonsmokers
  • no regular medication (in particular no drugs affecting platelet function or vascular function)

Exclusion Criteria:

  • exposition to secondhand smoke within 1 week before inclusion
  • use of drugs affecting platelet function or vascular function within 1 week before study inclusion
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 50 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Switzerland
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00923988
Other Study ID Numbers  ICMJE SHS-EF
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Walter H. Reinhart, Head of the Department of Internal Medicine, Kantonsspital Graubuenden, Kantonsspital Graubuenden, Chur, Switzerland
Study Sponsor  ICMJE Kantonsspital Graubünden
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Piero O. Bonetti, MD Division of Cardiology, Department of Internal Medicine, Kantonsspital Graubuenden, Loestrasse 170, CH-7000 Chur, Switzerland
PRS Account Kantonsspital Graubünden
Verification Date August 2009

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