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Dose-dependent Effects of Second-hand Smoke on Vascular Function

This study has been completed.
Sponsor:
Information provided by:
University of California, San Francisco
ClinicalTrials.gov Identifier:
NCT01007760
First received: November 3, 2009
Last updated: July 18, 2011
Last verified: July 2011
History of Changes

November 3, 2009
July 18, 2011
November 2009
June 2010   (final data collection date for primary outcome measure)
Brachial Artery Flow-mediated dilation (FMD) [ Time Frame: Same day - before/after exposure ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01007760 on ClinicalTrials.gov Archive Site
Plasma measurement of asymmetric dimethylarginine (ADMA) and Nitrotyrosine levels [ Time Frame: Same day - before/after exposure ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Dose-dependent Effects of Second-hand Smoke on Vascular Function
Dose-dependent Biological Mechanisms of Second-hand Smoke on Endothelial Function and Oxidative Stress

The purpose of this study is to determine the vascular effects of brief second-hand smoke exposure on normal healthy individuals.

Second-hand smoke remains a significant public health threat. Despite evidence to suggest that secondhand smoke contributes to adverse cardiovascular outcomes, little is known about the dose-dependent vascular effects of brief secondhand smoke exposure at low doses commonly encountered in the community. This study will investigate the acute vascular effects and dose-dependent biological mechanisms of secondhand smoke on endothelial function and oxidative stress.
Interventional
Not Provided
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Outcomes Assessor)
Primary Purpose: Basic Science
Cardiovascular Disease
Other: Respirable suspended particles (RSP) PM 2.5 dose of second-hand smoke
acute one time exposure
Other Name: Respirable suspended particles (RSP) PM 2.5 dose of second-hand smoke
  • Placebo Comparator: Room air
    Intervention: Other: Respirable suspended particles (RSP) PM 2.5 dose of second-hand smoke
  • Active Comparator: Low dose exposure second-hand smoke
    Intervention: Other: Respirable suspended particles (RSP) PM 2.5 dose of second-hand smoke
  • Active Comparator: High dose exposure second-hand smoke
    Intervention: Other: Respirable suspended particles (RSP) PM 2.5 dose of second-hand smoke
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
33
July 2011
June 2010   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Healthy non-smoking adults

Exclusion Criteria:

  • Reported Active Smoking
  • History of diabetes, hypertension, chronic respiratory disease, coronary artery disease, prior myocardial infarction or heart failure
  • Pregnancy or breastfeeding
  • Current use of prescription drugs within 14 days of trial
  • Reported significant passive smoke exposure or elevated cotinine levels
Both
18 Years to 40 Years
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01007760
TRDRP-18FT-0049
No
Peter Ganz, M.D., UCSF
University of California, San Francisco
Not Provided
Principal Investigator: Peter Ganz, MD UCSF San Francisco General Hospital
University of California, San Francisco
July 2011

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