Atrium; FibrillationNCT03487419
Echocardiographic Left Atrial Function Assessment and Atrial Fibrillation Post-Coronary Artery Bypass Surgery
An observational study of Atrium; Fibrillation, run by National Heart Institute, Egypt at 1 site in Egypt.
Trial summary
The aim of this study to investigate the correlation between preoperative LA function using 2D echocardiography and left atrium 2D speckle tracking strain echocardiography and the development of Post Operative AF after CABG. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Atrium; Fibrillation
- How many people
- 100 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Aug 2018to 1 Dec 2020
- How long will I take part?
- 1 Month
- 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
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: adult patients with preoperative sinus rhythm who were referred for elective isolated CABG (no other concomitant cardiac or extracardiac procedures) were enrolled. Standard transthoracic echocardiography and left atrial 2D speckle tracking strain echocardiography were performed preoperatively. After surgery, patients received continuous electrocardiography (ECG) monitoring throughout hospitalization in the coronary care unit.
Who may be able to join
- • Patients with preoperative sinus rhythm who were referred for elective isolated CABG (no other concomitant cardiac or extracardiac procedures).
- Patient age more than18 years old.
Who cannot join
- • Any type of arrhythmia other than sinus.
- Hyperthyroidism or hypothyroidism.
- Renal failure requiring hemodialysis .
- Moderate to severe valvular heart disease.
- Current use of antiarrhythmic drugs .
- Recent myocardial infarction within a month before surgery.
- Patient with redo CABG.
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
National Heart Institute
Cairo, Kit Kat, 12651
faten dr farid, md, 01005586659, faten-farid@hotmail.com
About this study
Official title: Relationship Between Echocardiographic Left Atrial Function Assessment and Atrial Fibrillation Post-Coronary Artery Bypass Surgery
The aim of this study to investigate the correlation between preoperative LA function using 2D echocardiography and left atrium 2D speckle tracking strain echocardiography and the development of Post Operative AF after CABG.
the investigators chose electrocardiography as a reference standard for detection of Post Operative AF. LA dysfunction is diagnosed with Echocardiography
Read the detailed description
Atrial fibrillation (AF) is one of the most common postoperative complications following cardiac surgery. This in turn translates into longer hospitalization, increased cost of hospitalization as well as association with thromboembolic events and mortality .
Despite new-onset postoperative atrial fibrillation (NoPOAF) occurring in 20-40% of patients following coronary artery bypass graft (CABG) surgery, the underlying mechanisms are not well established. However, it has been traditionally thought to be transient and benign to the patient.
Recent evidence suggests that POAF may be more 'malignant' than previously thought, associated with follow-up mortality and morbidity.
Previously, increased left atrial (LA) size and LA dysfunction have been shown to be related to the subsequent development of atrial fibrillation (AF), stroke, myocardial infarction, and heart failure.
Also, recent studies suggest that LA dysfunction caused by the effects of oxidative stress, inflammation, and atrial fibrosis, has a role. In other words, by acute functional depression, preoperative LA dysfunction may be the starting point of the development of POAF after coronary artery bypass grafting (CABG).(8) Therefore, as the improvement in the evaluation of LA function, preoperative LA dysfunction may emerge as an important component in the identification of patients with the risk of POAF after CABG surgery.
Echocardiography is the most common diagnostic method for assessing atrial function but the technique has some limitations. Traditionally, assessment of left atrial function has been performed by measuring volumes with 2D echocardiography. Additionally, it can be assessed with transmitral Doppler and pulmonary vein Doppler. Recently, an alternative method has been incorporated, namely, measurement of myocardial deformation with color tissue Doppler-derived strain.
However, this method has several limitations, such as suboptimal reproducibility, angle-dependence, signal artifacts and the fact that it only measures regional strain and does not obtain information about the curved portion of the atrial roof. To overcome these limitations in the quantification of atrial function, the use of speckle tracking echocardiography (STE) strain has been proposed. This technique is not derived from Doppler but rather from 2D echocardiography, it is angle-independent, and allows us to measure global as well as regional atrial strain. STE is a new technique of 2D echocardiography image analysis that allows the study of regional atrial myocardial deformation expressed by a dimensionless parameter.
2-dimensional (2D) speckle tracking strain imaging is a feasible and reproducible technique for the assessment of LA function by evaluating LA deformation dynamics.
- Conditions
- Atrium; Fibrillation
- Keywords
- left atrial echocardiography, new onset atrial fibrillation, coronary artery bypass grafting, speckle tracking echocardiography
- 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 |
|---|---|---|
| patients develop atrial fibrillation | patients post coronary artery bypass grafting who develop atrial fibrillation post operative | |
| patients who not develop atrial fibrillation | patients post coronary artery bypass grafting who don't develop atrial fibrillation post operative |
What is being measured
The primary outcome is the main question the study is designed to answer.
Development of new onset atrial fibrillation post coronary artery bypass grafting surgery during ICU stay and hospital stay till discharge and its relation to left atrial function assessed by echocardiography
assessment of left atrium function by echocardiography and its relation to incidence of new onset atrial fibrillation during hospital stay
Measured: baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Apr 2018
- Study start1 Aug 2018
- Primary completion30 Dec 2019 (estimated)
- Study completion1 Dec 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (10)Papers the sponsor has linked to this study.
- Other trials for Atrium; 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
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 100 participants (estimated)
- Target duration
- 1 Month
Sponsor and investigators
- Lead sponsor
- National Heart Institute, Egypt
- Sponsor type
- Other government
- Responsible party
- Principal investigator, hossam ahmed hamed hussein, National Heart Institute, Egypt
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03487419
- Sponsor's protocol ID
- left atrial speckle tracking
- Status last verified
- Apr 2019
- First submitted
- 27 Mar 2018
- Last updated
- 1 May 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Echahidi N, Pibarot P, O'Hara G, Mathieu P. Mechanisms, prevention, and treatment of atrial fibrillation after cardiac surgery. J Am Coll Cardiol. 2008 Feb 26;51(8):793-801. doi: 10.1016/j.jacc.2007.10.043.
PubMed 18294562Haghjoo M. Pharmacological and nonpharmacological prevention of atrial fibrillation after coronary artery bypass surgery. J Tehran Heart Cent. 2012 Winter;7(1):2-9. Epub 2012 Feb 28.
PubMed 23074627Levy D, Kannel WB. Postoperative atrial fibrillation and mortality: do the risks merit changes in clinical practice? J Am Coll Cardiol. 2004 Mar 3;43(5):749-51. doi: 10.1016/j.jacc.2003.12.011. No abstract available.
PubMed 14998611Borde D, Gandhe U, Hargave N, Pandey K, Mathew M, Joshi S. Prediction of postoperative atrial fibrillation after coronary artery bypass grafting surgery: is CHA 2 DS 2 -VASc score useful? Ann Card Anaesth. 2014 Jul-Sep;17(3):182-7. doi: 10.4103/0971-9784.135841.
PubMed 24994728Mariscalco G, Engstrom KG. Postoperative atrial fibrillation is associated with late mortality after coronary surgery, but not after valvular surgery. Ann Thorac Surg. 2009 Dec;88(6):1871-6. doi: 10.1016/j.athoracsur.2009.07.074.
PubMed 19932252Abhayaratna WP, Seward JB, Appleton CP, Douglas PS, Oh JK, Tajik AJ, Tsang TS. Left atrial size: physiologic determinants and clinical applications. J Am Coll Cardiol. 2006 Jun 20;47(12):2357-63. doi: 10.1016/j.jacc.2006.02.048.
PubMed 16781359Elahi MM, Flatman S, Matata BM. Tracing the origins of postoperative atrial fibrillation: the concept of oxidative stress-mediated myocardial injury phenomenon. Eur J Cardiovasc Prev Rehabil. 2008 Dec;15(6):735-41. doi: 10.1097/HJR.0b013e328317f38a.
PubMed 19020458Her AY, Kim JY, Kim YH, Choi EY, Min PK, Yoon YW, Lee BK, Hong BK, Rim SJ, Kwon HM. Left atrial strain assessed by speckle tracking imaging is related to new-onset atrial fibrillation after coronary artery bypass grafting. Can J Cardiol. 2013 Mar;29(3):377-83. doi: 10.1016/j.cjca.2012.06.006. Epub 2012 Aug 15.
PubMed 22902158Cianciulli TF, Saccheri MC, Lax JA, Bermann AM, Ferreiro DE. Two-dimensional speckle tracking echocardiography for the assessment of atrial function. World J Cardiol. 2010 Jul 26;2(7):163-70. doi: 10.4330/wjc.v2.i7.163.
PubMed 21160748Vianna-Pinton R, Moreno CA, Baxter CM, Lee KS, Tsang TS, Appleton CP. Two-dimensional speckle-tracking echocardiography of the left atrium: feasibility and regional contraction and relaxation differences in normal subjects. J Am Soc Echocardiogr. 2009 Mar;22(3):299-305. doi: 10.1016/j.echo.2008.12.017.
PubMed 19258177
Study at a glance
From the registry record, last updated by the sponsor on 1 May 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Relationship Between Echocardiographic Left Atrial Function Assessment and Atrial Fibrillation Post-Coronary Artery Bypass Surgery
- ClinicalTrials.gov ID
- NCT03487419
- Acronym / sponsor ID
- left atrial speckle tracking
- Conditions
- Atrium; Fibrillation
- Keywords
- left atrial echocardiography, new onset atrial fibrillation, coronary artery bypass grafting, speckle tracking echocardiography
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- National Heart Institute, EgyptOther government
- Study start
- 1 Aug 2018 (actual)
- Primary completion
- 30 Dec 2019 (estimated)
- Study completion
- 1 Dec 2020 (estimated)
- First posted
- 4 Apr 2018 (actual)
- 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.
The aim of this study to investigate the correlation between preoperative LA function using 2D echocardiography and left atrium 2D speckle tracking strain echocardiography and the development of Post Operative AF after CABG.
the investigators chose electrocardiography as a reference standard for detection of Post Operative AF. LA dysfunction is diagnosed with Echocardiography
Detailed description
Atrial fibrillation (AF) is one of the most common postoperative complications following cardiac surgery. This in turn translates into longer hospitalization, increased cost of hospitalization as well as association with thromboembolic events and mortality .
Despite new-onset postoperative atrial fibrillation (NoPOAF) occurring in 20-40% of patients following coronary artery bypass graft (CABG) surgery, the underlying mechanisms are not well established. However, it has been traditionally thought to be transient and benign to the patient.
Recent evidence suggests that POAF may be more 'malignant' than previously thought, associated with follow-up mortality and morbidity.
Previously, increased left atrial (LA) size and LA dysfunction have been shown to be related to the subsequent development of atrial fibrillation (AF), stroke, myocardial infarction, and heart failure.
Also, recent studies suggest that LA dysfunction caused by the effects of oxidative stress, inflammation, and atrial fibrosis, has a role. In other words, by acute functional depression, preoperative LA dysfunction may be the starting point of the development of POAF after coronary artery bypass grafting (CABG).(8) Therefore, as the improvement in the evaluation of LA function, preoperative LA dysfunction may emerge as an important component in the identification of patients with the risk of POAF after CABG surgery.
Echocardiography is the most common diagnostic method for assessing atrial function but the technique has some limitations. Traditionally, assessment of left atrial function has been performed by measuring volumes with 2D echocardiography. Additionally, it can be assessed with transmitral Doppler and pulmonary vein Doppler. Recently, an alternative method has been incorporated, namely, measurement of myocardial deformation with color tissue Doppler-derived strain.
However, this method has several limitations, such as suboptimal reproducibility, angle-dependence, signal artifacts and the fact that it only measures regional strain and does not obtain information about the curved portion of the atrial roof. To overcome these limitations in the quantification of atrial function, the use of speckle tracking echocardiography (STE) strain has been proposed. This technique is not derived from Doppler but rather from 2D echocardiography, it is angle-independent, and allows us to measure global as well as regional atrial strain. STE is a new technique of 2D echocardiography image analysis that allows the study of regional atrial myocardial deformation expressed by a dimensionless parameter.
2-dimensional (2D) speckle tracking strain imaging is a feasible and reproducible technique for the assessment of LA function by evaluating LA deformation dynamics.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Target follow-up
- 1 Month
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| patients develop atrial fibrillation | – | –patients post coronary artery bypass grafting who develop atrial fibrillation post operative |
| patients who not develop atrial fibrillation | – | –patients post coronary artery bypass grafting who don't develop atrial fibrillation post operative |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- adult patients with preoperative sinus rhythm who were referred for elective isolated CABG (no other concomitant cardiac or extracardiac procedures) were enrolled. Standard transthoracic echocardiography and left atrial 2D speckle tracking strain echocardiography were performed preoperatively. After surgery, patients received continuous electrocardiography (ECG) monitoring throughout hospitalization in the coronary care unit.
Key inclusion criteria (2 listed)
- • Patients with preoperative sinus rhythm who were referred for elective isolated CABG (no other concomitant cardiac or extracardiac procedures).
Key exclusion criteria (7 listed)
- • Any type of arrhythmia other than sinus.
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
Development of new onset atrial fibrillation post coronary artery bypass grafting surgery during ICU stay and hospital stay till discharge and its relation to left atrial function assessed by echocardiography
Time frame: baseline
assessment of left atrium function by echocardiography and its relation to incidence of new onset atrial fibrillation during hospital stay
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 May 2019.
- Results publication: PubMed 18294562Echahidi N, Pibarot P, O'Hara G, Mathieu P. Mechanisms, prevention, and treatment of atrial fibrillation after cardiac surgery. J Am Coll Cardiol. 2008 Feb 26;51(8):793-801. doi: 10.1016/j.jacc.2007.10.043.
- Results publication: PubMed 23074627Haghjoo M. Pharmacological and nonpharmacological prevention of atrial fibrillation after coronary artery bypass surgery. J Tehran Heart Cent. 2012 Winter;7(1):2-9. Epub 2012 Feb 28.
- Results publication: PubMed 14998611Levy D, Kannel WB. Postoperative atrial fibrillation and mortality: do the risks merit changes in clinical practice? J Am Coll Cardiol. 2004 Mar 3;43(5):749-51. doi: 10.1016/j.jacc.2003.12.011. No abstract available.
- Results publication: PubMed 24994728Borde D, Gandhe U, Hargave N, Pandey K, Mathew M, Joshi S. Prediction of postoperative atrial fibrillation after coronary artery bypass grafting surgery: is CHA 2 DS 2 -VASc score useful? Ann Card Anaesth. 2014 Jul-Sep;17(3):182-7. doi: 10.4103/0971-9784.135841.
- Results publication: PubMed 19932252Mariscalco G, Engstrom KG. Postoperative atrial fibrillation is associated with late mortality after coronary surgery, but not after valvular surgery. Ann Thorac Surg. 2009 Dec;88(6):1871-6. doi: 10.1016/j.athoracsur.2009.07.074.
- Results publication: PubMed 16781359Abhayaratna WP, Seward JB, Appleton CP, Douglas PS, Oh JK, Tajik AJ, Tsang TS. Left atrial size: physiologic determinants and clinical applications. J Am Coll Cardiol. 2006 Jun 20;47(12):2357-63. doi: 10.1016/j.jacc.2006.02.048.
- Results publication: PubMed 19020458Elahi MM, Flatman S, Matata BM. Tracing the origins of postoperative atrial fibrillation: the concept of oxidative stress-mediated myocardial injury phenomenon. Eur J Cardiovasc Prev Rehabil. 2008 Dec;15(6):735-41. doi: 10.1097/HJR.0b013e328317f38a.
- Results publication: PubMed 22902158Her AY, Kim JY, Kim YH, Choi EY, Min PK, Yoon YW, Lee BK, Hong BK, Rim SJ, Kwon HM. Left atrial strain assessed by speckle tracking imaging is related to new-onset atrial fibrillation after coronary artery bypass grafting. Can J Cardiol. 2013 Mar;29(3):377-83. doi: 10.1016/j.cjca.2012.06.006. Epub 2012 Aug 15.
- Results publication: PubMed 21160748Cianciulli TF, Saccheri MC, Lax JA, Bermann AM, Ferreiro DE. Two-dimensional speckle tracking echocardiography for the assessment of atrial function. World J Cardiol. 2010 Jul 26;2(7):163-70. doi: 10.4330/wjc.v2.i7.163.
- Results publication: PubMed 19258177Vianna-Pinton R, Moreno CA, Baxter CM, Lee KS, Tsang TS, Appleton CP. Two-dimensional speckle-tracking echocardiography of the left atrium: feasibility and regional contraction and relaxation differences in normal subjects. J Am Soc Echocardiogr. 2009 Mar;22(3):299-305. doi: 10.1016/j.echo.2008.12.017.
- Individual participant dataSharing planned: Undecided
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Atrial Fibrillation (AF)
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.
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 Atrium; Fibrillation, run by National Heart Institute, Egypt at 1 site in Egypt.
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 2 inclusion and 7 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: status not confirmed, as of the sponsor's last update on 1 May 2019. 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 Egypt. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact hossam ahmed hamed, msc (00201278965302, sir.hos@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Development of new onset atrial fibrillation post coronary artery bypass grafting surgery during ICU stay and hospital stay till discharge and its relation to left atrial function assessed by echocardiography (time frame: baseline). 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 NCT03487419, which also lists 10 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 1 May 2019.