Brugada ECG PatternsNCT05116488
Detection of Electrocardiographic Brugada Patterns Using High Precordial Leads
An observational study of Brugada ECG Patterns, run by Assiut University.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Brugada ECG Patterns
- What is being tested?
- ECG(electrocardigraph)
- How many people
- 300 participants
- Where
- No sites listed yet
- Study dates
- 31 Dec 2021to 31 Dec 2023
- 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 to 80 years
- All sexes
- Adult, Older adult
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.
Who may be able to join
- patients with IHD,HTN,DM with no organic heart disease by ECHO.
- healthy persons with normal structure heart by ECHO.
Who cannot join
- Acute coronary syndrome.
- cardiomyopathy.
- severe valvular heart disease.
- HTN heart disease with LVH.
- Malignancy.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: 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.
Read the 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.
- Conditions
- Brugada ECG Patterns
- Being tested
- ECG(electrocardigraph)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: up to 4 hours for each case to make sure of meeting eligibility criteria
Secondary outcomes (1)
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.
Measured: six months after diagnosis of Brugada pattern for each case
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Nov 2021
- Study start31 Dec 2021 (estimated)
- Primary completion31 Dec 2022 (estimated)
- Study completion31 Dec 2023 (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 Brugada ECG PatternsStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- 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
- Prospective
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Alaa Rashad Ali, Assiut University
- Investigators
- Salah Eldin Sayed Atta, Professor, Study director, Assiut UniversityMahmoud Abdelsabour, Lecturer, Study director, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05116488
- Sponsor's protocol ID
- ECG Brugada patterns
- Status last verified
- Nov 2021
- First submitted
- 16 Oct 2021
- Last updated
- 17 Nov 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
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.
PubMed 12417552Peritz 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.
PubMed 26850497Kapplinger 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.
PubMed 20129283Antzelevitch 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.
PubMed 15655131Patel 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.
PubMed 19545330Bachman 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.
PubMed 1462800Chung 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.
PubMed 26026871Sangwatanaroj 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.
PubMed 11728150Meregalli 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.
PubMed 15913579Ali 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.
PubMed 41524999
Study at a glance
From the registry record, last updated by the sponsor on 17 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Detection of Electrocardiographic Brugada Patterns Using High Precordial Leads Positioning Among Asymptomatic Upper Egyptian Population
- ClinicalTrials.gov ID
- NCT05116488
- Acronym / sponsor ID
- ECG Brugada patterns
- Conditions
- Brugada ECG Patterns
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 31 Dec 2021 (estimated)
- Primary completion
- 31 Dec 2022 (estimated)
- Study completion
- 31 Dec 2023 (estimated)
- First posted
- 11 Nov 2021 (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.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (2 listed)
- patients with IHD,HTN,DM with no organic heart disease by ECHO.
- healthy persons with normal structure heart by ECHO.
Key exclusion criteria (5 listed)
- Acute coronary syndrome.
- cardiomyopathy.
- severe valvular heart disease.
- HTN heart disease with LVH.
- Malignancy.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ECG(electrocardigraph)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. | Diagnostic test | – |
Primary outcome
Detection of electrocardiographic Brugada patterns using high precordial leads positioning among asymptomatic upper Egyptian population
Time frame: up to 4 hours for each case to make sure of meeting eligibility criteria
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.
1 secondary outcome
Follow up of positive cases
Time frame: six months after diagnosis of Brugada pattern for each case
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Nov 2021.
- Background: PubMed 12417552Wilde 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.
- Background: PubMed 26850497Peritz 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.
- Background: PubMed 20129283Kapplinger 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.
- Background: PubMed 15655131Antzelevitch 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.
- Background: PubMed 19545330Patel 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.
- Background: PubMed 1462800Bachman 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.
- Background: PubMed 26026871Chung 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.
- Background: PubMed 11728150Sangwatanaroj 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.
- Background: PubMed 15913579Meregalli 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.
- Derived from this study: PubMed 41524999Ali 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.
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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.
Salah Eldin Sayed Atta, Professor study director
Assiut University
Mahmoud Abdelsabour, Lecturer study director
Assiut University
Questions about this trial
What is this clinical trial studying?
An observational study of Brugada ECG Patterns, run by Assiut University.
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 5 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 17 Nov 2021. Status can change between updates, so confirm with the study contact before making plans.
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 Alaa Rashad, Resident (01026453282, alaarashad084@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Detection of electrocardiographic Brugada patterns using high precordial leads positioning among asymptomatic upper Egyptian population (time frame: up to 4 hours for each case to make sure of meeting eligibility criteria). 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 NCT05116488, 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 17 Nov 2021.