Effect of Passive Smoking on Platelet Function and Endothelial Function

Endothelial Function Clinical Trial

Official title:

Acute Effects of Short-term Exposure to Secondhand Smoke on Platelet Activation and Endothelial Function

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00923988
• Other study ID #: SHS-EF
• Status: Completed
• Phase: N/A
• First received: June 17, 2009
• Last updated: August 10, 2009
• Start date: June 2009
• Est. completion date: August 2009

Study information

• Verified date: August 2009
• Source: Kantonsspital Graubünden
• Contact: n/a
• Is FDA regulated: No
• Health authority: Switzerland: Ethikkommission
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: August 2009
• Est. primary completion date: August 2009
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 50 Years

Eligibility

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

Study Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Endothelial Function
• Platelet Aggregation

Intervention

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.

Locations

Country	Name	City	State
Switzerland	Kantonsspital Graubuenden	Chur

Sponsors (1)

Lead Sponsor	Collaborator
Kantonsspital Graubünden

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in platelet aggregation and/or endothelial function		12-24 hours	No