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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT03487419
Other study ID # left atrial speckle tracking
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date August 1, 2018
Est. completion date December 1, 2020

Study information

Verified date April 2019
Source National Heart Institute, Egypt
Contact hossam ahmed hamed, msc
Phone 00201278965302
Email sir.hos@gmail.com
Is FDA regulated No
Health authority
Study type Observational [Patient Registry]

Clinical 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.

the investigators chose electrocardiography as a reference standard for detection of Post Operative AF. LA dysfunction is diagnosed with Echocardiography


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 100
Est. completion date December 1, 2020
Est. primary completion date December 30, 2019
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria:

- • 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.

Exclusion Criteria:

- • 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.

Study Design


Related Conditions & MeSH terms


Locations

Country Name City State
Egypt National Heart Institute Cairo Kit Kat

Sponsors (1)

Lead Sponsor Collaborator
National Heart Institute, Egypt

Country where clinical trial is conducted

Egypt, 

References & Publications (10)

Abhayaratna 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. Review. — View Citation

Borde 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. — View Citation

Cianciulli 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. — View Citation

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. Review. — View Citation

Elahi 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. Revie — View Citation

Haghjoo 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. — View Citation

Her 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):37 — View Citation

Levy 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. — View Citation

Mariscalco G, Engström 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. — View Citation

Vianna-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 — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary 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 baseline
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