Southeast Asian Brugada Syndrome Cohort

NCT04232787 | Unknown

• 1 other identifier: 2558-114
• Study Type: observational
• Target: 750
• Locations: 1 country
• Sites: 11

Brief Summary

Brugada syndrome (BrS) is the leading cause of sudden death in young Asian adults including Thailand. This syndrome may be hereditary and involve mutations in certain genes. Aim of the study is to identify the relationship between genetic variants and the diagnosis/clinical severity of patients with BrS.

Conditions

Brugada Syndrome

Keywords

Brugada Syndrome; Genetics; Epidemiology; Thai; Southeast Asia

Outcome Measures

Primary Outcomes (1)

• Relationship between genetic variants and Brugada syndrome (Brugada syndrome phenotype)

  Case-Control study of genetic variants in BrS cases vs controls. Genetic study was done by whole genome sequencing and SNP array. Association analysis assessed by polygenic risk score and regression coefficients.

  7 years

Secondary Outcomes (2)

• Natural history of Brugada syndrome (survival from arrhythmic events)

  7 years

• Epidemiology of Brugada syndrome

  7 years

Study Arms (2)

Case

Thai patients with diagnosed Brugada syndrome by confirmed Brugada type 1 ECG.

Control

Healthy volunteers without Brugada marker from ECG.

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Thai Brugada syndrome patients and healthy volunteers

You may qualify if:

• Thai nationality
• The patient has at least one of confirmed Brugada type 1 ECG in at least one of right precordial leads (v1 or v2) with or without pharmacologic provocative testing. The confirmed ECG is standard 12 lead ECG or Brugada lead

You may not qualify if:

• The patient has other cardiac diseases such as ischemic heart disease, valvular heart disease, congenital heart disease, myocarditis and pericarditis
• The patient has type 2 or type 3 Brugada ECG without type 1 ECG during pharmacologic provocative testing and/or Brugada lead
• The patient had one time of Brugada type 1 ECG during drug use without reproducibility

Sponsors & Collaborators

• Chulalongkorn University: lead
• National Research Council of Thailand: collaborator
• Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA): collaborator

Study Sites (11)

Siriraj Hospital, Mahidol University

Bangkok Noi, Bangkok, 10700, Thailand

RECRUITING

Vajira Hospital

Dusit, Bangkok, 10300, Thailand

RECRUITING

Chulalongkorn University

Pathum Wan, Bangkok, 10330, Thailand

RECRUITING

Faculty of Medicine Ramathibodi Hospital, Mahidol University

Ratchathewi, Bangkok, 10400, Thailand

RECRUITING

Bhumibol Adulyadej RTAF Hospital

Sai Mai, Bangkok, 10220, Thailand

RECRUITING

Bumrungrad International Hospital

Vadhana, Bangkok, 10110, Thailand

RECRUITING

Pacific Rim Electrophysiology Research Institute Data Coordinating Center

Vadhana, Bangkok, 10110, Thailand

RECRUITING

Bangkok Hospital

Bangkok, 10310, Thailand

RECRUITING

Faculty of Medicine, Chiang Mai University

Chiang Mai, 50200, Thailand

RECRUITING

Queen Sirikit Heart Center of the Northeast

Khon Kaen, 40002, Thailand

RECRUITING

Central Chest Hospital

Nonthaburi, 11000, Thailand

RECRUITING

Related Publications (6)

• Deo R, Albert CM. Epidemiology and genetics of sudden cardiac death. Circulation. 2012 Jan 31;125(4):620-37. doi: 10.1161/CIRCULATIONAHA.111.023838. No abstract available.

  PMID: 22294707 RESULT

• Priori SG, Wilde AA, Horie M, Cho Y, Behr ER, Berul C, Blom N, Brugada J, Chiang CE, Huikuri H, Kannankeril P, Krahn A, Leenhardt A, Moss A, Schwartz PJ, Shimizu W, Tomaselli G, Tracy C. HRS/EHRA/APHRS expert consensus statement on the diagnosis and management of patients with inherited primary arrhythmia syndromes: document endorsed by HRS, EHRA, and APHRS in May 2013 and by ACCF, AHA, PACES, and AEPC in June 2013. Heart Rhythm. 2013 Dec;10(12):1932-63. doi: 10.1016/j.hrthm.2013.05.014. Epub 2013 Aug 30. No abstract available.

  PMID: 24011539 RESULT

• Nademanee K, Veerakul G, Nimmannit S, Chaowakul V, Bhuripanyo K, Likittanasombat K, Tunsanga K, Kuasirikul S, Malasit P, Tansupasawadikul S, Tatsanavivat P. Arrhythmogenic marker for the sudden unexplained death syndrome in Thai men. Circulation. 1997 Oct 21;96(8):2595-600. doi: 10.1161/01.cir.96.8.2595.

  PMID: 9355899 RESULT

• Bezzina CR, Barc J, Mizusawa Y, Remme CA, Gourraud JB, Simonet F, Verkerk AO, Schwartz PJ, Crotti L, Dagradi F, Guicheney P, Fressart V, Leenhardt A, Antzelevitch C, Bartkowiak S, Borggrefe M, Schimpf R, Schulze-Bahr E, Zumhagen S, Behr ER, Bastiaenen R, Tfelt-Hansen J, Olesen MS, Kaab S, Beckmann BM, Weeke P, Watanabe H, Endo N, Minamino T, Horie M, Ohno S, Hasegawa K, Makita N, Nogami A, Shimizu W, Aiba T, Froguel P, Balkau B, Lantieri O, Torchio M, Wiese C, Weber D, Wolswinkel R, Coronel R, Boukens BJ, Bezieau S, Charpentier E, Chatel S, Despres A, Gros F, Kyndt F, Lecointe S, Lindenbaum P, Portero V, Violleau J, Gessler M, Tan HL, Roden DM, Christoffels VM, Le Marec H, Wilde AA, Probst V, Schott JJ, Dina C, Redon R. Common variants at SCN5A-SCN10A and HEY2 are associated with Brugada syndrome, a rare disease with high risk of sudden cardiac death. Nat Genet. 2013 Sep;45(9):1044-9. doi: 10.1038/ng.2712. Epub 2013 Jul 21.

  PMID: 23872634 RESULT

• Chimparlee N, Prechawat S, Khongphatthanayothin A, Mauleekoonphairoj J, Lekchuensakul S, Wongcharoen W, Makarawate P, Sahasatas D, Krittayaphong R, Amnueypol M, Anannab A, Ngarmukos T, Vardhanabhuti S, Sutjaporn B, Wandee P, Veerakul G, Bezzina CR, Poovorawan Y, Nademanee K. Clinical Characteristics of SCN5A p.R965C Carriers: A Common Founder Variant Predisposing to Brugada Syndrome in Thailand. Circ Genom Precis Med. 2021 Jun;14(3):e003229. doi: 10.1161/CIRCGEN.120.003229. Epub 2021 Jun 7. No abstract available.

  PMID: 34092119 DERIVED

• Makarawate P, Glinge C, Khongphatthanayothin A, Walsh R, Mauleekoonphairoj J, Amnueypol M, Prechawat S, Wongcharoen W, Krittayaphong R, Anannab A, Lichtner P, Meitinger T, Tjong FVY, Lieve KVV, Amin AS, Sahasatas D, Ngarmukos T, Wichadakul D, Payungporn S, Sutjaporn B, Wandee P, Poovorawan Y, Tfelt-Hansen J, Tanck MWT, Tadros R, Wilde AAM, Bezzina CR, Veerakul G, Nademanee K. Common and rare susceptibility genetic variants predisposing to Brugada syndrome in Thailand. Heart Rhythm. 2020 Dec;17(12):2145-2153. doi: 10.1016/j.hrthm.2020.06.027. Epub 2020 Jun 30.

  PMID: 32619740 DERIVED

Related Links

• Project database

Biospecimen

Retention: SAMPLES WITH DNA

Whole blood

MeSH Terms

Conditions

Brugada Syndrome

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Cardiac Conduction System Disease; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

• Koonlawee Nademanee, MD

  Chulalongkorn University

  STUDY CHAIR

• Yong Poovorawan, MD

  Chulalongkorn University

  STUDY DIRECTOR

• Apichai Khongphatthanayothin, MD

  Chulalongkorn University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Apichai Khongphatthanayothin, MD

CONTACT

66891555545; apichaik@yahoo.com

Pharawee Wandee, BSc

CONTACT

66944174331; brugadaproject@gmail.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 7 Years
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Pediatrics, Division of Pediatric Cardiology, Department of Pediatrics, Faculty of Medicine

Study Record Dates

• First Submitted: January 13, 2020
• First Posted: January 18, 2020
• Study Start: January 28, 2016
• Primary Completion: January 1, 2021
• Study Completion: January 1, 2023
• Last Updated: January 18, 2020

Record last verified: 2020-01

Data Sharing

• IPD Sharing: Will share

Locations

TH (11)