NCT01007760

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
33

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Nov 2009

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2009

Completed
2 days until next milestone

First Submitted

Initial submission to the registry

November 3, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

November 4, 2009

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2010

Completed
1.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2011

Completed
Last Updated

July 19, 2011

Status Verified

July 1, 2011

Enrollment Period

7 months

First QC Date

November 3, 2009

Last Update Submit

July 18, 2011

Conditions

Cardiovascular Disease

Keywords

Tobacco smokeOxidative stressEndothelial FunctionAtherosclerosisArterial StiffnessMicrovascular Function

Outcome Measures

Primary Outcomes (1)

  • Brachial Artery Flow-mediated dilation (FMD)

    Same day - before/after exposure

Secondary Outcomes (1)

  • Plasma measurement of asymmetric dimethylarginine (ADMA) and Nitrotyrosine levels

    Same day - before/after exposure

Study Arms (3)

Room air

PLACEBO COMPARATOR
Other: Respirable suspended particles (RSP) PM 2.5 dose of second-hand smoke

Low dose exposure second-hand smoke

ACTIVE COMPARATOR
Other: Respirable suspended particles (RSP) PM 2.5 dose of second-hand smoke

High dose exposure second-hand smoke

ACTIVE COMPARATOR
Other: Respirable suspended particles (RSP) PM 2.5 dose of second-hand smoke

Interventions

Respirable suspended particles (RSP) PM 2.5 dose of second-hand smokeOTHER

acute one time exposure

High dose exposure second-hand smokeLow dose exposure second-hand smokeRoom air

Eligibility Criteria

Age18 Years - 40 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Healthy non-smoking adults

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

UCSF San Francisco General Hospital

San Francisco, California, 94110, United States

Location

MeSH Terms

Conditions

Cardiovascular DiseasesAtherosclerosis

Interventions

Tobacco Smoke Pollution

Condition Hierarchy (Ancestors)

ArteriosclerosisArterial Occlusive DiseasesVascular Diseases

Intervention Hierarchy (Ancestors)

SmokeParticulate MatterComplex MixturesAir PollutionEnvironmental PollutionPublic HealthEnvironment and Public Health

Study Officials

  • Peter Ganz, MD

    UCSF San Francisco General Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

November 3, 2009

First Posted

November 4, 2009

Study Start

November 1, 2009

Primary Completion

June 1, 2010

Study Completion

July 1, 2011

Last Updated

July 19, 2011

Record last verified: 2011-07

Locations

US(1)