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

July 18, 2011 updated by: University of California, San Francisco

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

33

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

  • United States
    • California
      • San Francisco, California, United States, 94110
        • UCSF San Francisco General Hospital

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 40 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

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: Basic Science
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Room air
Other: Respirable suspended particles (RSP) PM 2.5 dose of second-hand smoke
acute one time exposure
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
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

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of California, San Francisco

Investigators

  • Principal Investigator: Peter Ganz, MD, UCSF San Francisco General Hospital

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

November 1, 2009

Primary Completion (Actual)

June 1, 2010

Study Completion (Actual)

July 1, 2011

Study Registration Dates

First Submitted

November 3, 2009

First Submitted That Met QC Criteria

November 3, 2009

First Posted (Estimate)

November 4, 2009

Study Record Updates

Last Update Posted (Estimate)

July 19, 2011

Last Update Submitted That Met QC Criteria

July 18, 2011

Last Verified

July 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • TRDRP-18FT-0049

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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