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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01346956
Other study ID # 02AMCRAVSAND07
Secondary ID
Status Completed
Phase N/A
First received May 2, 2011
Last updated May 3, 2011
Start date July 2002
Est. completion date August 2002

Study information

Verified date January 2003
Source Andhra Medical College
Contact n/a
Is FDA regulated No
Health authority India: Drugs Controller General of India
Study type Observational

Clinical 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 20
Est. completion date August 2002
Est. primary completion date August 2002
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Male
Age group 18 Years and older
Eligibility 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 Design

Observational Model: Case-Only, Time Perspective: Prospective


Related Conditions & MeSH terms


Locations

Country Name City State
India Andhra Medical College Visakhapatnam Andhra Pradesh

Sponsors (1)

Lead Sponsor Collaborator
Andhra Medical College

Country where clinical trial is conducted

India, 

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