Clinical trial NCT00948454: Research Study on the Effects of Smoking on Arteries
Official title: The Dose Effect Of Cigarette-Smoking On Indices Of Arterial Function And Oxidative Stress
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Smoking
Keywords: smoking
Lead sponsor: University of Pennsylvania
Sponsor class: OTHER
Collaborators: name: National Institutes of Health (NIH)
First posted: 2009-07-29
Enrollment: 105
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
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.

Brief summary: 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.


Eligibility 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

Primary outcomes:
measure: To assess the dose-related effects of cigarette smoking on flow mediated arterial function in humans.
timeFrame: Study Day
Secondary outcomes:
measure: To assess the dose-related effects of cigarette smoking on COX activation.
timeFrame: Twice during study day
measure: To assess the dose-related effects of cigarette smoking on novel indices of lipid peroxidation, protein oxidation and DNA modification by lipid adducts.
timeFrame: Study day
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: University of Pennsylvania
state: Pennsylvania
Study officials:
affiliation: University of Pennsylvania
name: Garret A FitzGerald, MD
role: PRINCIPAL_INVESTIGATOR
References: