SmokingNCT00948454
Research Study on the Effects of Smoking on Arteries
An observational study of Smoking, run by University of Pennsylvania at 1 site in United States.
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… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Smoking
- How many people
- 105 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2003to Jun 2006
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Pennsylvania
Philadelphia, Pennsylvania, 19104
About this study
Official title: 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.
- Conditions
- Smoking
- Keywords
- smoking
- Medical subject headings
- Smoking
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
To assess the dose-related effects of cigarette smoking on flow mediated arterial function in humans.
Measured: Study Day
Secondary outcomes (2)
To assess the dose-related effects of cigarette smoking on COX activation.
Measured: Twice during study day
To assess the dose-related effects of cigarette smoking on novel indices of lipid peroxidation, protein oxidation and DNA modification by lipid adducts.
Measured: Study day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jul 2009 (estimated)
- Study startJan 2003
- Primary completionMay 2006
- Study completionJun 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SmokingStudies of the same condition, open and under way.
- More trials run by University of PennsylvaniaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 105 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Pennsylvania
- Sponsor type
- University, hospital or other
- Collaborators
- National Institutes of Health (NIH)
- Investigators
- Garret A FitzGerald, MD, Principal investigator, University of Pennsylvania
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00948454
- Sponsor's protocol ID
- 704074
- Other IDs
- 0775
- Status last verified
- Oct 2009
- First submitted
- 28 Jul 2009
- Last updated
- 27 Oct 2009
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Oct 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Dose Effect Of Cigarette-Smoking On Indices Of Arterial Function And Oxidative Stress
- ClinicalTrials.gov ID
- NCT00948454
- Acronym / sponsor ID
- 704074
- Conditions
- Smoking
- Keywords
- smoking
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 105 participants (actual)
- Lead sponsor
- University of PennsylvaniaUniversity, hospital or other
- Collaborators
- National Institutes of Health (NIH)
- Study start
- Jan 2003
- Primary completion
- May 2006 (actual)
- Study completion
- Jun 2006 (actual)
- First posted
- 29 Jul 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
To assess the dose-related effects of cigarette smoking on flow mediated arterial function in humans.
Time frame: Study Day
2 secondary outcomes
To assess the dose-related effects of cigarette smoking on COX activation.
Time frame: Twice during study day
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Oct 2009.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Garret A FitzGerald, MD principal investigator
University of Pennsylvania
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Smoking, run by University of Pennsylvania at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Oct 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To assess the dose-related effects of cigarette smoking on flow mediated arterial function in humans. (time frame: Study Day). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Oct 2009.