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

Cardiovascular Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01007760
• Other study ID #: TRDRP-18FT-0049
• Status: Completed
• Phase: N/A
• First received: November 3, 2009
• Last updated: July 18, 2011
• Start date: November 2009
• Est. completion date: July 2011

Study information

• Verified date: July 2011
• Source: University of California, San Francisco
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 33
• Est. completion date: July 2011
• Est. primary completion date: June 2010
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 40 Years

Eligibility

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 Design

Allocation: Non-Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Cardiovascular Disease
• Cardiovascular Diseases

Intervention

Other:
• Respirable suspended particles (RSP) PM 2.5 dose of second-hand smoke
acute one time exposure

Locations

Country	Name	City	State
United States	UCSF San Francisco General Hospital	San Francisco	California

Sponsors (1)

Lead Sponsor	Collaborator
University of California, San Francisco

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Brachial Artery Flow-mediated dilation (FMD)		Same day - before/after exposure	No
Secondary	Plasma measurement of asymmetric dimethylarginine (ADMA) and Nitrotyrosine levels		Same day - before/after exposure	No