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

Study Overview
=================
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.

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

Conditions
-----------------
Cardiovascular Disease

Intervention / Treatment
-----------------
* Other: Respirable suspended particles (RSP) PM 2.5 dose of second-hand smoke


Participation Criteria
=================
Eligibility 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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 40 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Basic Science
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Room air<br> | Other: Respirable suspended particles (RSP) PM 2.5 dose of second-hand smoke<br>* acute one time exposure<br>|
| Active Comparator: Low dose exposure second-hand smoke<br> | Other: Respirable suspended particles (RSP) PM 2.5 dose of second-hand smoke<br>* acute one time exposure<br>|
| Active Comparator: High dose exposure second-hand smoke<br> | Other: Respirable suspended particles (RSP) PM 2.5 dose of second-hand smoke<br>* acute one time exposure<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

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

Secondary Outcome Measures

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

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Tobacco smoke, Oxidative stress, Endothelial Function, Atherosclerosis, Arterial Stiffness, Microvascular Function