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

Overview

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

Full Title of Study: “Dose-dependent Biological Mechanisms of Second-hand Smoke on Endothelial Function and Oxidative Stress”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Non-Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Basic Science
    • Masking: Double (Participant, Outcomes Assessor)
  • Study Primary Completion Date: June 2010

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.

Interventions

  • Other: Respirable suspended particles (RSP) PM 2.5 dose of second-hand smoke
    • acute one time exposure

Arms, Groups and Cohorts

  • Placebo Comparator: Room air
  • Active Comparator: Low dose exposure second-hand smoke
  • Active Comparator: High dose exposure second-hand smoke

Clinical Trial Outcome Measures

Primary Measures

  • Brachial Artery Flow-mediated dilation (FMD)
    • Time Frame: Same day – before/after exposure

Secondary Measures

  • Plasma measurement of asymmetric dimethylarginine (ADMA) and Nitrotyrosine levels
    • Time Frame: Same day – before/after exposure

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: 40 Years

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

  • Lead Sponsor
    • University of California, San Francisco
  • Provider of Information About this Clinical Study
    • Peter Ganz, M.D., UCSF
  • Overall Official(s)
    • Peter Ganz, MD, Principal Investigator, UCSF San Francisco General Hospital

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