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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 July 29, 2014