- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00923988
Effect of Passive Smoking on Platelet Function and Endothelial Function
August 10, 2009 updated by: Kantonsspital Graubünden
Acute Effects of Short-term Exposure to Secondhand Smoke on Platelet Activation and Endothelial Function
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Anticipated)
40
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Chur, Switzerland, 7000
- Kantonsspital Graubuenden
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 50 years (ADULT)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: PREVENTION
- Allocation: NA
- Interventional Model: SINGLE_GROUP
- Masking: NONE
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Change in platelet aggregation and/or endothelial function
Time Frame: 12-24 hours
|
12-24 hours
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Piero O. Bonetti, MD, Division of Cardiology, Department of Internal Medicine, Kantonsspital Graubuenden, Loestrasse 170, CH-7000 Chur, Switzerland
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
June 1, 2009
Primary Completion (ACTUAL)
August 1, 2009
Study Completion (ACTUAL)
August 1, 2009
Study Registration Dates
First Submitted
June 17, 2009
First Submitted That Met QC Criteria
June 17, 2009
First Posted (ESTIMATE)
June 18, 2009
Study Record Updates
Last Update Posted (ESTIMATE)
August 11, 2009
Last Update Submitted That Met QC Criteria
August 10, 2009
Last Verified
August 1, 2009
More Information
Terms related to this study
Other Study ID Numbers
- SHS-EF
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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