Research Study on the Effects of Smoking on Arteries

NCT ID: NCT00948454

Last Updated: 2009-10-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

105 participants

Study Classification

OBSERVATIONAL

Study Start Date

2003-01-31

Study Completion Date

2006-06-30

Brief Summary

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The current proposal, will elucidate the role of oxidant stress (OS) on arterial function as measured by flow mediated vasodilation. In addition, the investigators will address the hypothesis, that a pro-oxidant might have different degrees of effects on different biological targets, by performing quantitative assessment of the effects of OS on lipids, proteins and DNA.

Detailed Description

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Conditions

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Smoking

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

CROSS_SECTIONAL

Study Groups

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Light smokers

2 blood draws, 3 urine collections and a test called an FMD which tests the circulation in your arm via ultrasound will be performed on the study day. Subjects will bring their own cigarettes on that day and smoke their regular amount. Female subjects will also have a pregnancy test done on the test day.

No interventions assigned to this group

Heavy Smokers

2 blood draws, 3 urine collections and a test called an FMD which tests the circulation in your arm via ultrasound will be performed on the study day. Subjects will bring their own cigarettes on that day and smoke their regular amount. Female subjects will also have a pregnancy test done on the test day.

No interventions assigned to this group

Non Smokers

2 blood draws, 3 urine collections and a test called an FMD which tests the circulation in your arm via ultrasound will be performed on the study day. Female subjects will also have a pregnancy test done on the test day.

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

* Chronic smokers (of between 4 and 20 years duration) and non-smokers will be recruited to the GCRC. Smokers will be allocated to a "light" group, smoking 4-10 cigarettes per day and a "heavy" smoking group who smoke 11-20 cigarettes per day.
* Non-smokers will be defined as those with a life time consumption of no more than 20 cigarettes, do not live or work in a smoky atmosphere.
* All individuals will have a normal history and clinical examination, including a normal EKG, urinalysis and serum chemistry, haemogram and negative urinary pregnancy test.

Exclusion Criteria

* previously suffered an acute major cardiovascular event
* those with a chronic disease
* those taking chronic medication
* those with a history of alcoholism or substance abuse
* Ex-smokers
* Subjects, who have less than or equal to 60% platelet aggregation in response to arachidonic acid
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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National Institutes of Health (NIH)

NIH

Sponsor Role collaborator

University of Pennsylvania

OTHER

Sponsor Role lead

Responsible Party

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University of Pennsylvania

Principal Investigators

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Garret A FitzGerald, MD

Role: PRINCIPAL_INVESTIGATOR

University of Pennsylvania

Locations

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University of Pennsylvania

Philadelphia, Pennsylvania, United States

Site Status

Countries

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United States

Other Identifiers

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0775

Identifier Type: -

Identifier Source: secondary_id

704074

Identifier Type: -

Identifier Source: org_study_id

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