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OpenTrials
Completed

NCT Number: NCT00948454

Research Study on the Effects of Smoking on Arteries

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.

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Key information

Conditions

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. To assess the dose-related effects of cigarette smoking on flow mediated arterial function in humans.

    Time frame: Study Day

Secondary outcomes

  1. To assess the dose-related effects of cigarette smoking on COX activation.

    Time frame: Twice during study day

  2. 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

Sponsors and collaborators

Lead sponsor

University of Pennsylvania

Other

Collaborators

  • National Institutes of Health (NIH)

Registry information

Official study title

The Dose Effect Of Cigarette-Smoking On Indices Of Arterial Function And Oxidative Stress

Important dates

Study start
2003
Primary completion
2006
Study completion
2006
First posted
Jul 29, 2009
Registry last updated
Oct 27, 2009

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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