- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01346956
Acute Cardiovascular Effects of Cigarette Smoking
May 3, 2011 updated by: Andhra Medical College
Twenty healthy smokers will be subjected to measurement of Pulse, Blood Pressure, electrocardiogram (ECG) and Echo at baseline and after smoking a cigarette.
The measurements will be compare for any cardiovascular effects of a cigarette smoking on these parameters.
Study Overview
Status
Completed
Conditions
Detailed Description
Twenty male persons habituated to smoking (at least 5 cigarettes/day) will be recruited after an informed consent.
Healthy persons with no systemic illness will be included.
After a history and a routine examination, subjects will be asked to abstain from smoking for 3 hours and then their pulse, BP, ECG and echo recorded.
The measurements will be repeated after 15 min.
and the average of these two taken as baseline readings.
Then, they will be asked to smoke a cigarette and the measurements taken again.
Special focus will be on Doppler measures of left ventricular (LV) function.
The measurements are repeated immediately and at 5,10 and 15 min.
The data will be analyzed for any cardiovascular effects of smoking a cigarette.
Chi square test for proportions and t-test for means will be done.
A p value < 0.05 will be taken as significant.
Study Type
Observational
Enrollment (Actual)
20
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Andhra Pradesh
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Visakhapatnam, Andhra Pradesh, India, 530002
- Andhra Medical College
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
Male
Sampling Method
Non-Probability Sample
Study Population
Twenty healthy male smokers
Description
Inclusion Criteria:
- Healthy male smokers (at least 5 cigarettes /day) >18 years old.
Exclusion Criteria:
- Any cardiac or respiratory or systemic illness,including hypertension.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Venkatachelam R Chitrapu, MD DM, Andhra Medical College
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
July 1, 2002
Primary Completion (Actual)
August 1, 2002
Study Completion (Actual)
August 1, 2002
Study Registration Dates
First Submitted
May 2, 2011
First Submitted That Met QC Criteria
May 3, 2011
First Posted (Estimate)
May 4, 2011
Study Record Updates
Last Update Posted (Estimate)
May 4, 2011
Last Update Submitted That Met QC Criteria
May 3, 2011
Last Verified
January 1, 2003
More Information
Terms related to this study
Other Study ID Numbers
- 02AMCRAVSAND07
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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