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
  Purpose

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


Condition Intervention
Cardiovascular Disease
Other: Respirable suspended particles (RSP) PM 2.5 dose of second-hand smoke

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Outcomes Assessor)
Primary Purpose: Basic Science
Official Title: Dose-dependent Biological Mechanisms of Second-hand Smoke on Endothelial Function and Oxidative Stress

Resource links provided by NLM:


Further study details as provided by University of California, San Francisco:

Primary Outcome Measures:
  • Brachial Artery Flow-mediated dilation (FMD) [ Time Frame: Same day - before/after exposure ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Plasma measurement of asymmetric dimethylarginine (ADMA) and Nitrotyrosine levels [ Time Frame: Same day - before/after exposure ] [ Designated as safety issue: No ]

Enrollment: 33
Study Start Date: November 2009
Study Completion Date: July 2011
Primary Completion Date: June 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Room air 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
Active Comparator: Low dose exposure second-hand smoke 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
Active Comparator: High dose exposure second-hand smoke 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

Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   18 Years to 40 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01007760

Locations
United States, California
UCSF San Francisco General Hospital
San Francisco, California, United States, 94110
Sponsors and Collaborators
University of California, San Francisco
Investigators
Principal Investigator: Peter Ganz, MD UCSF San Francisco General Hospital
  More Information

No publications provided

Responsible Party: Peter Ganz, M.D., UCSF
ClinicalTrials.gov Identifier: NCT01007760     History of Changes
Other Study ID Numbers: TRDRP-18FT-0049
Study First Received: November 3, 2009
Last Updated: July 18, 2011
Health Authority: United States: Institutional Review Board

Keywords provided by University of California, San Francisco:
Tobacco smoke
Oxidative stress
Endothelial Function
Atherosclerosis
Arterial Stiffness
Microvascular Function

Additional relevant MeSH terms:
Cardiovascular Diseases

ClinicalTrials.gov processed this record on April 23, 2014