Atrial FibrillationNCT00646997
Impact of Left Atrial Function on Postoperative Atrial Fibrillation
An observational study of Atrial Fibrillation, run by Florence Nightingale Hospital, Istanbul at 1 site in Turkey (Türkiye).
Trial summary
We aimed to demonstrate the impact of left atrial functions which were evaluated by three different echocardiographic modalities , on postoperative atrial fibrillation. Read more about this study
- Who is it for?
- Ages 30 to 80 years
- Conditions the study is for
- Atrial Fibrillation
- How many people
- 80 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- Mar 2008to May 2008
- 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 30 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Tertiary care clinic
Who may be able to join
- 1Coronary artery disease evidenced by coronary angiography
- 2Patients with a decision of undergoing elective coronary artery bypass greft operation
- 3Sinus rhythm in electrocardiography
Who cannot join
- 1Rheumatic valve disease
- 2Having prosthetic valve
- 3CABG accompanied by other cardiac interventions (such as valvular surgery, ASD closure...etc)
- 4Left ventricular l ejection fraction <40%
- 5Mild to moderate mitral stenosis or regurgitation
- 6Having atrial fibrillation or a history of atrial fibrillation attach during the last two weeks.
Show all 10Show fewer
- 7Congenital heart disease
- 8Chronic liver disease
- 9Chronic renal disease
- 10Malignancy
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
TC.Istanbul Bilim University, Florence Nightingale Hospital, Division of Cardiology
Istanbul, 34381
About this study
Official title: Impact Of Velocity Vector Imaging, Tissue Doppler Imaging, Conventional Echocardiography And P Wave Dispertion In Evaluating Post-Operative Atrial Fibrillation After Coronary Bypass Graft Surgery
We aimed to demonstrate the impact of left atrial functions which were evaluated by three different echocardiographic modalities , on postoperative atrial fibrillation.
Read the detailed description
Postoperative atrial fibrillation after coronary artery bypass greft operation (CABG) is major complication with a prevalence of 10-50%. Although the men mechanism is not known, in recent studies, age and left atrial function have been demonstrated as the most responsible factors. Velocity vector imaging (VVI) is a new modality which may give accurate and detailed information on both left atrial segmental and global function. In this study, our aim was to assess preoperative left atrial function by using three different echocardiographic modalities, VVI, tissue Doppler imaging and conventional echocardiography and evaluate the relation between the left atrial functions and the development of post-operative atrial fibrillation after CABG.
- Conditions
- Atrial Fibrillation
- Keywords
- atrial fibrillation, left atrium, velocity vector imaging
- Medical subject headings
- Atrial Fibrillation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Patients with postoperative atrial fibrillation | |
| 2 | Patients without postoperative atrial fibrillation. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Velocity vector imaging derived left atrial segmenter function, Tissue doppler derved left atrial segmenter function, conventional analysis of atrial function by 2D and pulsed wave echocardiography.
Measured: April 2008
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Mar 2008 (estimated)
- Study startMar 2008
- Primary completionMay 2008
- Study completionMay 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Atrial FibrillationStudies 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 crossover
- Time perspective
- Prospective
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Florence Nightingale Hospital, Istanbul
- Sponsor type
- University, hospital or other
- Investigators
- Saide Aytekin, Professor, Study director, T.C. Istanbul Bilim University, Florence Nightingale Hospital, Division of Cardiology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00646997
- Sponsor's protocol ID
- YT1977/2
- Status last verified
- Jun 2008
- First submitted
- 26 Mar 2008
- Last updated
- 30 Jun 2008
- Results posted
- No
- Data monitoring committee
- Yes
Publications
1-Leung JM, Bellows WH, Schiller NB. Impairment of left atrial function predicts post-operative atrial fibrillation after coronary artery bypass graft surgery. European H J. 2004,25,1836-1844 2-Nakai T , Lee R, Schiller N, et al. The relative importance of left atrial function versus dimension in predicting atrial fibrilation after coronary bypass graft surgery. Am H Journal. 2002; 143:181-6
Study at a glance
From the registry record, last updated by the sponsor on 30 Jun 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact Of Velocity Vector Imaging, Tissue Doppler Imaging, Conventional Echocardiography And P Wave Dispertion In Evaluating Post-Operative Atrial Fibrillation After Coronary Bypass Graft Surgery
- ClinicalTrials.gov ID
- NCT00646997
- Acronym / sponsor ID
- YT1977/2
- Conditions
- Atrial Fibrillation
- Keywords
- atrial fibrillation, left atrium, velocity vector imaging
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Florence Nightingale Hospital, IstanbulUniversity, hospital or other
- Study start
- Mar 2008
- Primary completion
- May 2008 (actual)
- Study completion
- May 2008 (actual)
- First posted
- 31 Mar 2008 (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.
We aimed to demonstrate the impact of left atrial functions which were evaluated by three different echocardiographic modalities , on postoperative atrial fibrillation.
Detailed description
Postoperative atrial fibrillation after coronary artery bypass greft operation (CABG) is major complication with a prevalence of 10-50%. Although the men mechanism is not known, in recent studies, age and left atrial function have been demonstrated as the most responsible factors. Velocity vector imaging (VVI) is a new modality which may give accurate and detailed information on both left atrial segmental and global function. In this study, our aim was to assess preoperative left atrial function by using three different echocardiographic modalities, VVI, tissue Doppler imaging and conventional echocardiography and evaluate the relation between the left atrial functions and the development of post-operative atrial fibrillation after CABG.
Study design
- Observational model
- Case crossover
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | – | –Patients with postoperative atrial fibrillation |
| 2 | – | –Patients without postoperative atrial fibrillation. |
Who may qualify
- Ages
- 30 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Tertiary care clinic
Key inclusion criteria (3 listed)
- 1Coronary artery disease evidenced by coronary angiography
- 2Patients with a decision of undergoing elective coronary artery bypass greft operation
- 3Sinus rhythm in electrocardiography
Key exclusion criteria (10 listed)
- 1Rheumatic valve disease
- 2Having prosthetic valve
- 3CABG accompanied by other cardiac interventions (such as valvular surgery, ASD closure...etc)
- 4Left ventricular l ejection fraction <40%
- 5Mild to moderate mitral stenosis or regurgitation
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
Velocity vector imaging derived left atrial segmenter function, Tissue doppler derved left atrial segmenter function, conventional analysis of atrial function by 2D and pulsed wave echocardiography.
Time frame: April 2008
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 30 Jun 2008.
- Background1-Leung JM, Bellows WH, Schiller NB. Impairment of left atrial function predicts post-operative atrial fibrillation after coronary artery bypass graft surgery. European H J. 2004,25,1836-1844 2-Nakai T , Lee R, Schiller N, et al. The relative importance of left atrial function versus dimension in predicting atrial fibrilation after coronary bypass graft surgery. Am H Journal. 2002; 143:181-6
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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.
Saide Aytekin, Professor study director
T.C. Istanbul Bilim University, Florence Nightingale Hospital, Division of Cardiology
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 Atrial Fibrillation, run by Florence Nightingale Hospital, Istanbul at 1 site in Turkey (Türkiye).
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 3 inclusion and 10 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 30 Jun 2008. 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 Turkey (Türkiye). 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.
What does the primary outcome measure?
Velocity vector imaging derived left atrial segmenter function, Tissue doppler derved left atrial segmenter function, conventional analysis of atrial function by 2D and pulsed wave echocardiography. (time frame: April 2008). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00646997, which also lists 1 linked publication.
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 30 Jun 2008.