NCT00923988

Brief Summary

Passive smoking is associated with an increased risk for cardiovascular events. However, the exact mechanisms by which passive smoking affects cardiovascular health are not entirely understood. In the present study, the researchers investigate the effects of short-term exposure to secondhand smoke on platelet function and peripheral microvascular endothelial function in healthy individuals. For this purpose, platelet function and endothelial function are measured before and after a 1-hour exposure to secondhand smoke in a concentration that is encountered in bars and restaurants without smoke-free policies. The researchers' hypothesis is that short-term exposure leads to platelet activation and impairment of endothelial function.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jun 2009

Shorter than P25 for not_applicable

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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2009

Completed
16 days until next milestone

First Submitted

Initial submission to the registry

June 17, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

June 18, 2009

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2009

Completed
Last Updated

August 11, 2009

Status Verified

August 1, 2009

Enrollment Period

2 months

First QC Date

June 17, 2009

Last Update Submit

August 10, 2009

Conditions

Keywords

Secondhand smokepassive smokingplatelet functionendothelial function

Outcome Measures

Primary Outcomes (1)

  • Change in platelet aggregation and/or endothelial function

    12-24 hours

Interventions

Participants will be exposed to secondhand smoke for one hour. As a measure of secondhand smoke exposition, room carbon monoxide concentration will be continuously measured using an Ambient Carbon Monoxide Monitor APMA-360 and kept constant between 4.5-6.0 ppm. Levels in this magnitude are typically seen in smoking areas of restaurants and bars.

Eligibility Criteria

Age18 Years - 50 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • healthy individuals
  • nonsmokers
  • no regular medication (in particular no drugs affecting platelet function or vascular function)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kantonsspital Graubuenden

Chur, 7000, Switzerland

Location

Study Officials

  • Piero O. Bonetti, MD

    Division of Cardiology, Department of Internal Medicine, Kantonsspital Graubuenden, Loestrasse 170, CH-7000 Chur, Switzerland

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

June 17, 2009

First Posted

June 18, 2009

Study Start

June 1, 2009

Primary Completion

August 1, 2009

Study Completion

August 1, 2009

Last Updated

August 11, 2009

Record last verified: 2009-08

Locations