NCT00948454|Completed
Research Study on the Effects of Smoking on Arteries
The Dose Effect Of Cigarette-Smoking On Indices Of Arterial Function And Oxidative Stress
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The Dose Effect Of Cigarette-Smoking On Indices Of Arterial Function And Oxidative Stress
Sponsor study identifier
Secondary identifiers
observational
105
1 country
1
Study Start
January 2003
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
May 2006
Actual (reported)Study Completion
June 2006
Actual (reported)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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
June 2006
Actual (reported)Click on a node to explore related trials.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
January 2003
Date type not reportedThis date has not been verified as actual or estimated.
May 2006
Actual (reported)June 2006
Actual (reported)July 28, 2009
Actual (reported)July 29, 2009
Actual (reported)To assess the dose-related effects of cigarette smoking on flow mediated arterial function in humans.
Study Day
To assess the dose-related effects of cigarette smoking on COX activation.
Twice during study day
To assess the dose-related effects of cigarette smoking on novel indices of lipid peroxidation, protein oxidation and DNA modification by lipid adducts.
Study day
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.
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.
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.
Chronic smokers (of between 4 and 20 years duration) and non-smokers will be recruited. 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.
University of Pennsylvania
Philadelphia, Pennsylvania, 19104, United States
Buffy coat from 4ml of blood will be stored for future genomic and proteomic analysis. Blood will also be collected for telemore length. This will be performed at an outside institution. Identifiers will be stripped from the samples prior to send out.
Garret A FitzGerald, MD
University of Pennsylvania
105 participants (actual enrollment reported by the registry).
First Submitted
July 28, 2009
First Posted
July 29, 2009
Study Start
January 2003
Date type not reportedThis date has not been verified as actual or estimated.
Young Adults' Responses to Anti-smoking Messages
Contact the study team to confirm eligibility.
Primary Completion
May 2006
Actual (reported)Study Completion
June 2006
Actual (reported)Last Updated
October 27, 2009
Record last verified: 2009-10
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Source: ClinicalTrials.gov.
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