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Research Study on the Effects of Smoking on Arteries

This study has been completed.
Sponsor:
Collaborator:
National Institutes of Health (NIH)
Information provided by:
University of Pennsylvania
ClinicalTrials.gov Identifier:
NCT00948454
First received: July 28, 2009
Last updated: October 23, 2009
Last verified: October 2009
History of Changes
  Purpose

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.


Condition
Smoking

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Cross-Sectional
Official Title: The Dose Effect Of Cigarette-Smoking On Indices Of Arterial Function And Oxidative Stress

Resource links provided by NLM:

MedlinePlus related topics: Smoking
U.S. FDA Resources

Further study details as provided by University of Pennsylvania:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Biospecimen Retention:   Samples With DNA

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.


Enrollment: 105
Study Start Date: January 2003
Study Completion Date: June 2006
Primary Completion Date: May 2006 (Final data collection date for primary outcome measure)
Groups/Cohorts
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

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.

Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00948454

Locations
United States, Pennsylvania
University of Pennsylvania
Philadelphia, Pennsylvania, United States, 19104
Sponsors and Collaborators
University of Pennsylvania
National Institutes of Health (NIH)
Investigators
Principal Investigator: Garret A FitzGerald, MD University of Pennsylvania
  More Information

No publications provided

Responsible Party: Garret A. FitzGerald Chair Department of Pharmacology Director, Institute for Translational Medicine & Therapeutics, University of Pennsylvania
ClinicalTrials.gov Identifier: NCT00948454     History of Changes
Other Study ID Numbers: 704074, 0775
Study First Received: July 28, 2009
Last Updated: October 23, 2009
Health Authority: United States: Institutional Review Board

Keywords provided by University of Pennsylvania:
smoking

Additional relevant MeSH terms:
Smoking
Habits

ClinicalTrials.gov processed this record on May 16, 2013