Research Study on the Effects of Smoking on Arteries

Smoking Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00948454
• Other study ID #: 704074
• Secondary ID: 0775
• Status: Completed
• Phase: N/A
• First received: July 28, 2009
• Last updated: October 23, 2009
• Start date: January 2003
• Est. completion date: June 2006

Study information

• Verified date: October 2009
• Source: University of Pennsylvania
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 105
• Est. completion date: June 2006
• Est. primary completion date: May 2006
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Observational Model: Case Control, Time Perspective: Cross-Sectional

Related Conditions & MeSH terms

• Smoking

Locations

Country	Name	City	State
United States	University of Pennsylvania	Philadelphia	Pennsylvania

Sponsors (2)

Lead Sponsor	Collaborator
University of Pennsylvania	National Institutes of Health (NIH)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To assess the dose-related effects of cigarette smoking on flow mediated arterial function in humans.		Study Day	No
Secondary	To assess the dose-related effects of cigarette smoking on COX activation.		Twice during study day	No
Secondary	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	No