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

• Sponsor: University of California, San Francisco (Other)
• Overall Status: Completed
• CT.gov ID: NCT01007760
• Collaborator: (none)
• Enrollment: 33
• Location: 1
• Arms: 3
• Duration (Months): 19.9
• Patients Per Site Per Month: 1.7

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Cardiovascular Disease	Other: Respirable suspended particles (RSP) PM 2.5 dose of second-hand smoke	N/A

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.

Study Design

• Study Type: Interventional
• Actual Enrollment: 33 participants
• Allocation: Non-Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Outcomes Assessor)
• Primary Purpose: Basic Science
• Official Title: Dose-dependent Biological Mechanisms of Second-hand Smoke on Endothelial Function and Oxidative Stress
• Study Start Date: Nov 1, 2009
• Actual Primary Completion Date: Jun 1, 2010
• Actual Study Completion Date: Jul 1, 2011

Arms and Interventions

Arm	Intervention/Treatment
Placebo Comparator: Room air	Other: Respirable suspended particles (RSP) PM 2.5 dose of second-hand smoke; acute one time exposure
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
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

Outcome Measures

Primary Outcome Measures

1. Brachial Artery Flow-mediated dilation (FMD) [Same day - before/after exposure]

Secondary Outcome Measures

1. Plasma measurement of asymmetric dimethylarginine (ADMA) and Nitrotyrosine levels [Same day - before/after exposure]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 40 Years
• Sexes Eligible for Study: All
• Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• ClinicalTrials.gov Identifier: NCT01007760
• Other Study ID Numbers: TRDRP-18FT-0049
• First Posted: Nov 4, 2009
• Last Update Posted: Jul 19, 2011
• Last Verified: Jul 1, 2011

• Keywords provided by , ,: Tobacco smoke; Oxidative stress; Endothelial Function; Atherosclerosis; Arterial Stiffness; Microvascular Function
• Additional relevant MeSH terms: Cardiovascular Diseases

Study Results

No Results Posted as of Jul 19, 2011