NCT05116488

Brief Summary

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.

Trial Health

35
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
300

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Dec 2021

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

October 16, 2021

Completed
26 days until next milestone

First Posted

Study publicly available on registry

November 11, 2021

Completed
2 months until next milestone

Study Start

First participant enrolled

December 31, 2021

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2022

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2023

Completed
Last Updated

November 17, 2021

Status Verified

November 1, 2021

Enrollment Period

1 year

First QC Date

October 16, 2021

Last Update Submit

November 10, 2021

Conditions

Brugada ECG Patterns

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • Follow up of positive cases

    six months after diagnosis of Brugada pattern for each case

Interventions

ECG(electrocardigraph)DIAGNOSTIC_TEST

Detection of electrocardiographic Brugada patterns using high precordial leads positioning as placing the precordial leads in the second intercostal space has been proposed to add sensitivity to the ECG diagnosis of Brugada syndrome.

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

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

You may not qualify if:

  • Acute coronary syndrome.
  • cardiomyopathy.
  • severe valvular heart disease.
  • HTN heart disease with LVH.
  • Malignancy.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (10)

  • 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.

    PMID: 12417552BACKGROUND

  • 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.

    PMID: 26850497BACKGROUND

  • 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.

    PMID: 20129283BACKGROUND

  • 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.

    PMID: 15655131BACKGROUND

  • 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.

    PMID: 19545330BACKGROUND

  • 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.

    PMID: 1462800BACKGROUND

  • 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.

    PMID: 26026871BACKGROUND

  • 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.

    PMID: 11728150BACKGROUND

  • 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.

    PMID: 15913579BACKGROUND

  • Ali AR, Abdelsabour M, Atta S. Yield of regular practice of high precordial leads electrocardiogram among asymptomatic upper Egyptian population considering Brugada patterns, a cross-sectional study. Egypt Heart J. 2026 Jan 12;78(1):4. doi: 10.1186/s43044-026-00714-x.

    PMID: 41524999DERIVED

Study Officials

  • Salah Eldin Sayed Atta, Professor

    Assiut University

    STUDY DIRECTOR

  • Mahmoud Abdelsabour, Lecturer

    Assiut University

    STUDY DIRECTOR

Central Study Contacts

Alaa Rashad, Resident

CONTACT

01026453282alaarashad084@gmail.com

Salah Eldin Sayed Atta, Professor

CONTACT

01091318801salah_s_atta@hotmail.com

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Doctor

Study Record Dates

First Submitted

October 16, 2021

First Posted

November 11, 2021

Study Start

December 31, 2021

Primary Completion

December 31, 2022

Study Completion

December 31, 2023

Last Updated

November 17, 2021

Record last verified: 2021-11