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

Not Applicable

Completed

• Conditions: Cardiovascular Disease
• Interventions: Other: Respirable suspended particles (RSP) PM 2.5 dose of second-hand smoke

• Registration Number: NCT01007760
• Lead Sponsor: University of California, San Francisco

Brief Summary

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

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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2009-11
• Study First Submitted: 2009-11-03
• Study First Submitted QC: 2009-11-03
• Study First Posted: 2009-11-04
• Primary Completion: 2010-06
• Status Verified: 2011-07
• Study Completion: 2011-07
• Last Update Submitted: 2011-07-18
• Last Update Posted: 2011-07-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 33

Inclusion Criteria

• Healthy non-smoking adults

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Room air	Respirable suspended particles (RSP) PM 2.5 dose of second-hand smoke	-
Low dose exposure second-hand smoke	Respirable suspended particles (RSP) PM 2.5 dose of second-hand smoke	-
High dose exposure second-hand smoke	Respirable suspended particles (RSP) PM 2.5 dose of second-hand smoke	-

Primary Outcome Measures

Name	Time	Method
Brachial Artery Flow-mediated dilation (FMD)	Same day - before/after exposure

Secondary Outcome Measures

Name	Time	Method
Plasma measurement of asymmetric dimethylarginine (ADMA) and Nitrotyrosine levels	Same day - before/after exposure

Trial Locations

Locations (1)

UCSF San Francisco General Hospital; 🇺🇸 San Francisco, California, United States