SmokingNCT01346956
Acute Cardiovascular Effects of Cigarette Smoking
An observational study of Smoking, run by Andhra Medical College at 1 site in India.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older, men onlyHealthy volunteers can take part
- Conditions the study is for
- Smoking
- How many people
- 20 participants
- Where
- 1 siteIndia
- Study dates
- Jul 2002to Aug 2002
- 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
- Men only
- Healthy volunteers accepted
- Adult, Older adult
Study population: Twenty healthy male smokers
Who may be able to join
- Healthy male smokers (at least 5 cigarettes /day) >18 years old.
Who cannot join
- Any cardiac or respiratory or systemic illness,including hypertension.
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- Smoking
- Keywords
- Cigarette, Smoking, Cardiovascular Effects, 2D Echocardiography, Doppler
- Medical subject headings
- Smoking
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 May 2011 (estimated)
- Study startJul 2002
- Primary completionAug 2002
- Study completionAug 2002
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.
- 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 only
- Time perspective
- Prospective
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Andhra Medical College
- Sponsor type
- Other government
- Investigators
- Venkatachelam R Chitrapu, MD DM, Principal investigator, Andhra Medical College
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01346956
- Sponsor's protocol ID
- 02AMCRAVSAND07
- Status last verified
- Jan 2003
- First submitted
- 2 May 2011
- Last updated
- 4 May 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 May 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Acute Cardiovascular Effects of Cigarette Smoking
- ClinicalTrials.gov ID
- NCT01346956
- Acronym / sponsor ID
- 02AMCRAVSAND07
- Conditions
- Smoking
- Keywords
- Cigarette, Smoking, Cardiovascular Effects, 2D Echocardiography, Doppler
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Andhra Medical CollegeOther government
- Study start
- Jul 2002
- Primary completion
- Aug 2002 (actual)
- Study completion
- Aug 2002 (actual)
- First posted
- 4 May 2011 (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.
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.
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 design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Twenty healthy male smokers
Key inclusion criteria (1 listed)
- Healthy male smokers (at least 5 cigarettes /day) >18 years old.
Key exclusion criteria (1 listed)
- Any cardiac or respiratory or systemic illness,including hypertension.
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
Not reported in the source record.
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 4 May 2011.
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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.
Venkatachelam R Chitrapu, MD DM principal investigator
Andhra Medical College
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 Andhra Medical College at 1 site in India.
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 1 inclusion and 1 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 4 May 2011. 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 India. 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.
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 4 May 2011.