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

Dose-dependent Biological Mechanisms of Second-hand Smoke on Endothelial Function and Oxidative Stress

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01007760

Enrollment

Registered

2009-11-04

Start date

2009-11-30

Completion date

2011-07-31

Last updated

2011-07-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cardiovascular Disease

Keywords

Tobacco smoke, Oxidative stress, Endothelial Function, Atherosclerosis, Arterial Stiffness, Microvascular Function

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.

Interventions

OTHERRespirable suspended particles (RSP) PM 2.5 dose of second-hand smoke

acute one time exposure

Study design

Allocation

NON_RANDOMIZED

Intervention model

PARALLEL

Primary purpose

BASIC_SCIENCE

Masking

DOUBLE (Subject, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to 40 Years

Healthy volunteers

Yes

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

Design outcomes

Primary

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

Secondary

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

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026