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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00395928
Other study ID # KB/126/2001
Secondary ID
Status Completed
Phase N/A
First received November 2, 2006
Last updated November 3, 2006
Start date November 2001
Est. completion date November 2004

Study information

Verified date November 2006
Source Medical University of Warsaw
Contact n/a
Is FDA regulated No
Health authority Poland: Ministry of Health
Study type Observational

Clinical Trial Summary

Impairment of relaxation, the early phase of ventricular diastole is the first stage of heart diastolic dysfunction. Left ventricular diastolic function can be determined noninvasively by Echo- Doppler – derived mitral valve flow velocities. The addition of pulmonary venous flow pattern enables more accurate assessment of left ventricle diastolic function. The role of the right ventricle in haemodynamic function of the heart is now emphasized. The right ventricle diastolic function can be assess by recording the Doppler tricuspid valve flow pattern. Impaired LV diastolic function usually precedes systolic dysfunction and may cause clinical signs of congestive heart failure. Cigarette smoking is one of the major risk factors for cardiovascular diseases. The aim of the study was to assess left and right ventricular diastolic function in healthy, young and slim smokers before and after smoking one cigarette.

Echocardiographic examination: before and after smoking one cigarette Echocardiographic evaluation of mitral valve flow, pulmonary venous flow, tricuspid valve flow and hepatic vein flow to assess diastolic function of ventricles.


Description:

Echocardiographic examination: in left lateral position after 10 minutes rest. The first examination: after a 2-hour non-smoking period, the second: immediately after smoking one cigarette containing 0.9 mg of nicotine. The duration of the second examination: no more than 15 minutes.

Echocardiography equipment: Hewlett-Packard SONOS 2000 (Andover, Massachusetts) imaging system. The transducer’s frequency: 2 MHz.

From the apical four chamber view the visualisation of transmitral flow, pulmonary venous flow and transtricuspid flow. From subcostal view the visualisation of right superior hepatic vein and the hepatic vein flow.


Recruitment information / eligibility

Status Completed
Enrollment 33
Est. completion date November 2004
Est. primary completion date
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 18 Years to 40 Years
Eligibility Inclusion Criteria:

- Smokers smoking over 10 cigarettes per day over the last 5 years

- Body mass index < 25 kg/m2

- Normal blood pressure and normal parameters of echocardiographic examination (wall thickness, left- and right- chamber size, valvular function and left and right ventricular systolic function)

- Normal results of routine physical examination, chest x-ray, standard rest electrocardiogram and routine laboratory tests.

Exclusion Criteria:

- Body mass index > 25 kg/m2

- Abnormal blood pressure

- Abnormal parameters of echocardiographic examination (wall thickness, left- and right- chamber size, valvular function and left and right ventricular systolic function)

- Abnormal results of routine physical examination, chest x-ray, standard rest electrocardiogram and routine laboratory tests.

Study Design

Observational Model: Defined Population, Time Perspective: Cross-Sectional


Related Conditions & MeSH terms


Locations

Country Name City State
Poland Internal Medicine and Cardiology Dpt,Institute of Dentistry,Warsaw Medical University Warsaw Lindleya 4

Sponsors (1)

Lead Sponsor Collaborator
Medical University of Warsaw

Country where clinical trial is conducted

Poland, 

References & Publications (4)

Alam M, Samad BA, Wardell J, Andersson E, Höglund C, Nordlander R. Acute effects of smoking on diastolic function in healthy participants: studies by conventional doppler echocardiography and doppler tissue imaging. J Am Soc Echocardiogr. 2002 Oct;15(10 Pt 2):1232-7. — View Citation

Klein AL, Tajik AJ. Doppler assessment of pulmonary venous flow in healthy subjects and in patients with heart disease. J Am Soc Echocardiogr. 1991 Jul-Aug;4(4):379-92. Review. — View Citation

Oh JK, Appleton CP, Hatle LK, Nishimura RA, Seward JB, Tajik AJ. The noninvasive assessment of left ventricular diastolic function with two-dimensional and Doppler echocardiography. J Am Soc Echocardiogr. 1997 Apr;10(3):246-70. — View Citation

Voutilainen S, Kupari M, Hippeläinen M, Karppinen K, Ventilä M, Heikkilä J. Factors influencing Doppler indexes of left ventricular filling in healthy persons. Am J Cardiol. 1991 Sep 1;68(6):653-9. — View Citation

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