Effect of Passive Smoking on Platelet Function and Endothelial Function

This study has been completed.
Sponsor:
Information provided by:
Kantonsspital Graubünden
ClinicalTrials.gov Identifier:
NCT00923988
First received: June 17, 2009
Last updated: August 10, 2009
Last verified: August 2009
  Purpose

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.


Condition Intervention
Endothelial Function
Platelet Aggregation
Other: secondhand smoke exposure

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Acute Effects of Short-term Exposure to Secondhand Smoke on Platelet Activation and Endothelial Function

Resource links provided by NLM:


Further study details as provided by Kantonsspital Graubünden:

Primary Outcome Measures:
  • Change in platelet aggregation and/or endothelial function [ Time Frame: 12-24 hours ] [ Designated as safety issue: No ]

Estimated Enrollment: 40
Study Start Date: June 2009
Study Completion Date: August 2009
Primary Completion Date: August 2009 (Final data collection date for primary outcome measure)
Intervention Details:
    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.
  Eligibility

Ages Eligible for Study:   18 Years to 50 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
  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: NCT00923988

Locations
Switzerland
Kantonsspital Graubuenden
Chur, Switzerland, 7000
Sponsors and Collaborators
Kantonsspital Graubünden
Investigators
Principal Investigator: Piero O. Bonetti, MD Division of Cardiology, Department of Internal Medicine, Kantonsspital Graubuenden, Loestrasse 170, CH-7000 Chur, Switzerland
  More Information

No publications provided

Responsible Party: Walter H. Reinhart, Head of the Department of Internal Medicine, Kantonsspital Graubuenden, Kantonsspital Graubuenden, Chur, Switzerland
ClinicalTrials.gov Identifier: NCT00923988     History of Changes
Other Study ID Numbers: SHS-EF
Study First Received: June 17, 2009
Last Updated: August 10, 2009
Health Authority: Switzerland: Ethikkommission

Keywords provided by Kantonsspital Graubünden:
Secondhand smoke
passive smoking
platelet function
endothelial function

ClinicalTrials.gov processed this record on October 01, 2014