NCT03487419

Brief 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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Aug 2018

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 27, 2018

Completed
8 days until next milestone

First Posted

Study publicly available on registry

April 4, 2018

Completed
4 months until next milestone

Study Start

First participant enrolled

August 1, 2018

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 30, 2019

Completed
11 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2020

Completed
Last Updated

May 1, 2019

Status Verified

April 1, 2019

Enrollment Period

1.4 years

First QC Date

March 27, 2018

Last Update Submit

April 29, 2019

Conditions

Atrium; Fibrillation

Keywords

left atrial echocardiographynew onset atrial fibrillationcoronary artery bypass graftingspeckle tracking echocardiography

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (2)

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

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
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.

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

National Heart Institute

Cairo, Kit Kat, 12651, Egypt

RECRUITING

Related Publications (10)

  • 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.

    PMID: 18294562RESULT

  • 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.

    PMID: 23074627RESULT

  • 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. doi: 10.1016/j.jacc.2003.12.011. No abstract available.

    PMID: 14998611RESULT

  • 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: 10.4103/0971-9784.135841.

    PMID: 24994728RESULT

  • Mariscalco 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.

    PMID: 19932252RESULT

  • 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. doi: 10.1016/j.jacc.2006.02.048.

    PMID: 16781359RESULT

  • 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.

    PMID: 19020458RESULT

  • 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):377-83. doi: 10.1016/j.cjca.2012.06.006. Epub 2012 Aug 15.

    PMID: 22902158RESULT

  • 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.

    PMID: 21160748RESULT

  • 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;22(3):299-305. doi: 10.1016/j.echo.2008.12.017.

    PMID: 19258177RESULT

MeSH Terms

Conditions

Atrial Fibrillation

Condition Hierarchy (Ancestors)

Arrhythmias, CardiacHeart DiseasesCardiovascular DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Central Study Contacts

hossam ahmed hamed, msc

CONTACT

00201278965302sir.hos@gmail.com

faten farid, phd

CONTACT

00201005586659faten-icu@hotmail.com

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
CROSS SECTIONAL
Target Duration
1 Month
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

March 27, 2018

First Posted

April 4, 2018

Study Start

August 1, 2018

Primary Completion

December 30, 2019

Study Completion

December 1, 2020

Last Updated

May 1, 2019

Record last verified: 2019-04

Locations

EG(1)