Detection of Electrocardiographic Brugada Patterns Using High Precordial Leads

Detection of Electrocardiographic Brugada Patterns Using High Precordial Leads Positioning Among Asymptomatic Upper Egyptian Population

Detection of prevalence of Brugada patterns in our locality in asymptomatic patients , by standard 12 lead ECG level and high precordial ECG level, measuring how much the high precordial leads is more sensitive in Brugada patterns detection than standard level 12 lead ECG in our upper Egyptian population.

Study Overview

• Status: Not yet recruiting
• Conditions: Brugada ECG Patterns
• Intervention / Treatment: Diagnostic test: ECG(electrocardigraph)

Detailed Description

Detection of prevalence of Brugada patterns in our locality in asymptomatic patients , by standard 12 lead ECG level and high precordial ECG level, measuring how much the high precordial leads is more sensitive in Brugada patterns detection than standard level 12 lead ECG in our upper Egyptian population.

The study will include patients fulfilling our criteria presenting to cardiology outpatient clinic and emergency room of Assiut University hospitals.

• Study Type: Observational
• Enrollment (Anticipated): 300

Contacts and Locations

• Study Contact: Name: Alaa Rashad, Resident; Phone Number: 01026453282; Email: alaarashad084@gmail.com
• Study Contact Backup: Name: Salah Eldin Sayed Atta, Professor; Phone Number: 01091318801; Email: salah_s_atta@hotmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: N/A
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

The study will include patients fulfilling our criteria presenting to cardiology outpatient clinic and emergency room of Assiut University hospitals.

All patients will be subjected to:

A. Full history taking: including age, sex, history of DM, HTN, Smoking, dyslipidaemia symptoms of heart failure, symptoms of Coronary artery disease, and history of any previous arrhythmia.

B. Full Physical examination:

• General examination Systolic and diastolic blood pressure and heart rate assessment.
• Cardiac examination. C. Laboratory investigations: electrolytes ( to make sure they are within normal).

D. Standard 12lead ECG. E .High precordial ECG: to increase sensitivity of Brugada patterns detection. F. Echocardiography: to exclude structural heart disease.

Description

Inclusion Criteria:

1. patients with IHD,HTN,DM with no organic heart disease by ECHO.
2. healthy persons with normal structure heart by ECHO.

Exclusion Criteria:

1. Acute coronary syndrome.
2. cardiomyopathy.
3. severe valvular heart disease.
4. HTN heart disease with LVH.
5. Malignancy.

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Detection of electrocardiographic Brugada patterns using high precordial leads positioning among asymptomatic upper Egyptian population	Detection of prevalence of Brugada patterns in our locality in asymptomatic patients , by standard 12 lead ECG level and high precordial ECG level, measuring how much the high precordial leads is more sensitive in Brugada patterns detection than standard level 12 lead ECG in our upper Egyptian population.	up to 4 hours for each case to make sure of meeting eligibility criteria

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Follow up of positive cases	The positive cases will be educated regarding their condition, asked about their history of syncope and family history of sudden cardiac death and will be educated about avoiding and rapid management of fever and electrolyte disturbances and educated about the list of drugs to be avoided. The positive cases will be followed up for 6 months both clinically and by Holter at 1st, and 6th month for detection of subclinical ventricular arrhythmias.	six months after diagnosis of Brugada pattern for each case

Collaborators and Investigators

• Sponsor: Assiut University
• Investigators: Study Director: Salah Eldin Sayed Atta, Professor, Assiut University; Study Director: Mahmoud Abdelsabour, Lecturer, Assiut University

Publications and helpful links

General Publications

• Wilde AA, Antzelevitch C, Borggrefe M, Brugada J, Brugada R, Brugada P, Corrado D, Hauer RN, Kass RS, Nademanee K, Priori SG, Towbin JA; Study Group on the Molecular Basis of Arrhythmias of the European Society of Cardiology. Proposed diagnostic criteria for the Brugada syndrome: consensus report. Circulation. 2002 Nov 5;106(19):2514-9. doi: 10.1161/01.cir.0000034169.45752.4a. No abstract available.
• Peritz DC, Chung EH. Criteria for evaluating rSr' patterns due to high precordial ECG lead placement accurately confirm absence of a Brugada ECG pattern. J Electrocardiol. 2016 Mar-Apr;49(2):182-6. doi: 10.1016/j.jelectrocard.2015.12.015. Epub 2016 Jan 6.
• Kapplinger JD, Tester DJ, Alders M, Benito B, Berthet M, Brugada J, Brugada P, Fressart V, Guerchicoff A, Harris-Kerr C, Kamakura S, Kyndt F, Koopmann TT, Miyamoto Y, Pfeiffer R, Pollevick GD, Probst V, Zumhagen S, Vatta M, Towbin JA, Shimizu W, Schulze-Bahr E, Antzelevitch C, Salisbury BA, Guicheney P, Wilde AA, Brugada R, Schott JJ, Ackerman MJ. An international compendium of mutations in the SCN5A-encoded cardiac sodium channel in patients referred for Brugada syndrome genetic testing. Heart Rhythm. 2010 Jan;7(1):33-46. doi: 10.1016/j.hrthm.2009.09.069. Epub 2009 Oct 8.
• Antzelevitch C, Brugada P, Borggrefe M, Brugada J, Brugada R, Corrado D, Gussak I, LeMarec H, Nademanee K, Perez Riera AR, Shimizu W, Schulze-Bahr E, Tan H, Wilde A. Brugada syndrome: report of the second consensus conference: endorsed by the Heart Rhythm Society and the European Heart Rhythm Association. Circulation. 2005 Feb 8;111(5):659-70. doi: 10.1161/01.CIR.0000152479.54298.51. Epub 2005 Jan 17. Erratum In: Circulation. 2005 Jul 26;112(4):e74.
• Patel SS, Anees S, Ferrick KJ. Prevalence of a Brugada pattern electrocardiogram in an urban population in the United States. Pacing Clin Electrophysiol. 2009 Jun;32(6):704-8. doi: 10.1111/j.1540-8159.2009.02354.x. Erratum In: Pacing Clin Electrophysiol. 2009 Jul;32(7):968. Anees, Syed S [corrected to Anees, Syed].
• Bachman JW, Field CS, Hammersley CE. Educational program for premature labor. J Am Board Fam Pract. 1992 Nov-Dec;5(6):645-7. No abstract available.
• Chung EH. Brugada ECG patterns in athletes. J Electrocardiol. 2015 Jul-Aug;48(4):539-43. doi: 10.1016/j.jelectrocard.2015.05.001. Epub 2015 May 8.
• Sangwatanaroj S, Prechawat S, Sunsaneewitayakul B, Sitthisook S, Tosukhowong P, Tungsanga K. New electrocardiographic leads and the procainamide test for the detection of the Brugada sign in sudden unexplained death syndrome survivors and their relatives. Eur Heart J. 2001 Dec;22(24):2290-6. doi: 10.1053/euhj.2001.2691.
• Meregalli PG, Wilde AA, Tan HL. Pathophysiological mechanisms of Brugada syndrome: depolarization disorder, repolarization disorder, or more? Cardiovasc Res. 2005 Aug 15;67(3):367-78. doi: 10.1016/j.cardiores.2005.03.005.

Study record dates

Study Major Dates

• Study Start (ANTICIPATED): December 31, 2021
• Primary Completion (ANTICIPATED): December 31, 2022
• Study Completion (ANTICIPATED): December 31, 2023

Study Registration Dates

• First Submitted: October 16, 2021
• First Submitted That Met QC Criteria: November 8, 2021
• First Posted (ACTUAL): November 11, 2021

Study Record Updates

• Last Update Posted (ACTUAL): November 17, 2021
• Last Update Submitted That Met QC Criteria: November 10, 2021
• Last Verified: November 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Genetic Diseases, Inborn; Arrhythmias, Cardiac; Cardiac Conduction System Disease; Brugada Syndrome
• Other Study ID Numbers: ECG Brugada patterns

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No