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Research Study on the Effects of Smoking on Arteries

This study has been completed.
Sponsor:
Collaborator:
Information provided by:
University of Pennsylvania
ClinicalTrials.gov Identifier:
NCT00948454
First received: July 28, 2009
Last updated: October 23, 2009
Last verified: October 2009

July 28, 2009
October 23, 2009
January 2003
May 2006   (final data collection date for primary outcome measure)
To assess the dose-related effects of cigarette smoking on flow mediated arterial function in humans. [ Time Frame: Study Day ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00948454 on ClinicalTrials.gov Archive Site
  • To assess the dose-related effects of cigarette smoking on COX activation. [ Time Frame: Twice during study day ] [ Designated as safety issue: No ]
  • To assess the dose-related effects of cigarette smoking on novel indices of lipid peroxidation, protein oxidation and DNA modification by lipid adducts. [ Time Frame: Study day ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Research Study on the Effects of Smoking on Arteries
The Dose Effect Of Cigarette-Smoking On Indices Of Arterial Function And Oxidative Stress

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.

Not Provided
Observational
Observational Model: Case Control
Time Perspective: Cross-Sectional
Not Provided
Retention:   Samples With DNA
Description:

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.

Non-Probability Sample

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.

Smoking
Not Provided
  • 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.
  • 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.
  • 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.
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
105
June 2006
May 2006   (final data collection date for primary outcome measure)

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
Both
18 Years and older
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00948454
704074, 0775
No
Garret A. FitzGerald Chair Department of Pharmacology Director, Institute for Translational Medicine & Therapeutics, University of Pennsylvania
University of Pennsylvania
National Institutes of Health (NIH)
Principal Investigator: Garret A FitzGerald, MD University of Pennsylvania
University of Pennsylvania
October 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP