Cardiovascular DiseasesNCT00395928
Chronic and Acute Effects of Smoking on the Left and Right Ventricular Relaxation in Young Healthy Smokers
An observational study of Cardiovascular Diseases, run by Medical University of Warsaw at 1 site in Poland.
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. Read more about this study
- Who is it for?
- Ages 18 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Cardiovascular Diseases
- How many people
- 33 participants
- Where
- 1 sitePoland
- Study dates
- Nov 2001to Nov 2004
- 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 to 40 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Poland1 site
Internal Medicine and Cardiology Dpt,Institute of Dentistry,Warsaw Medical University
Warsaw, Lindleya 4, 02 005
About this study
Official title: Chronic and Acute Effect of Smoking on the Left and Right Ventricular Systolic and Diastolic Function in Young Healthy Smokers
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.
Read the detailed 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.
- Conditions
- Cardiovascular Diseases
- Keywords
- heart, echocardiography, diastolic function, left ventricle, right ventricle, cigarette smoking, Smoking, Heart Ventricles, Diastole, Doppler Echocardiography
- Medical subject headings
- Cardiovascular Diseases, Cigarette Smoking, Smoking, Heart Murmurs
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Nov 2006 (estimated)
- Study startNov 2001
- Study completionNov 2004
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Cardiovascular DiseasesStudies of the same condition, open and under way.
- More trials run by Medical University of WarsawThe 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
- Defined population
- Time perspective
- Other
- Enrolment
- 33 participants
Sponsor and investigators
- Lead sponsor
- Medical University of Warsaw
- Sponsor type
- University, hospital or other
- Investigators
- Danuta Liszewska-Pfejfer, Prof., Study chair, Internal Medicine and Cardiology Dpt, Warsaw Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00395928
- Sponsor's protocol ID
- KB/126/2001
- Status last verified
- Nov 2006
- First submitted
- 2 Nov 2006
- Last updated
- 6 Nov 2006
- Results posted
- No
Publications
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. doi: 10.1016/s0894-7317(97)70062-2.
PubMed 9109691Klein 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. doi: 10.1016/s0894-7317(14)80448-3.
PubMed 1910836Voutilainen S, Kupari M, Hippelainen M, Karppinen K, Ventila M, Heikkila J. Factors influencing Doppler indexes of left ventricular filling in healthy persons. Am J Cardiol. 1991 Sep 1;68(6):653-9. doi: 10.1016/0002-9149(91)90360-w.
PubMed 1877483Alam M, Samad BA, Wardell J, Andersson E, Hoglund 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. doi: 10.1067/mje.2002.124006.
PubMed 12411910
Study at a glance
From the registry record, last updated by the sponsor on 6 Nov 2006. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Chronic and Acute Effect of Smoking on the Left and Right Ventricular Systolic and Diastolic Function in Young Healthy Smokers
- ClinicalTrials.gov ID
- NCT00395928
- Acronym / sponsor ID
- KB/126/2001
- Conditions
- Cardiovascular Diseases
- Keywords
- heart, echocardiography, diastolic function, left ventricle, right ventricle, cigarette smoking, Smoking, Heart Ventricles
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 33 participants
- Lead sponsor
- Medical University of WarsawUniversity, hospital or other
- Study start
- Nov 2001
- Study completion
- Nov 2004
- First posted
- 6 Nov 2006 (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.
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.
Detailed 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.
Study design
- Observational model
- Defined population
- Time perspective
- Other
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
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 6 Nov 2006.
- Background: PubMed 9109691Oh 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. doi: 10.1016/s0894-7317(97)70062-2.
- Background: PubMed 1910836Klein 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. doi: 10.1016/s0894-7317(14)80448-3.
- Background: PubMed 1877483Voutilainen S, Kupari M, Hippelainen M, Karppinen K, Ventila M, Heikkila J. Factors influencing Doppler indexes of left ventricular filling in healthy persons. Am J Cardiol. 1991 Sep 1;68(6):653-9. doi: 10.1016/0002-9149(91)90360-w.
- Background: PubMed 12411910Alam M, Samad BA, Wardell J, Andersson E, Hoglund 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. doi: 10.1067/mje.2002.124006.
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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.
Danuta Liszewska-Pfejfer, Prof. study chair
Internal Medicine and Cardiology Dpt, Warsaw Medical University
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 Cardiovascular Diseases, run by Medical University of Warsaw at 1 site in Poland.
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 4 inclusion and 4 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 6 Nov 2006. 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 Poland. 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?
On the ClinicalTrials.gov record for NCT00395928, which also lists 4 linked publications.
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 6 Nov 2006.