Southeast Asian Brugada Syndrome Cohort

NCT ID: NCT04232787

Last Updated: 2020-01-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

750 participants

Study Classification

OBSERVATIONAL

Study Start Date

2016-01-28

Study Completion Date

2023-01-31

Brief Summary

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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.

Detailed Description

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This cohort study recruits BrS patients with confirmed Brugada type 1 ECG and healthy volunteers in Thailand. Data collection consists of demographic, clinical data, ECG and blood sample for genetic studies. Genotyping was done by whole genome sequencing and SNP array then compared between cases and controls. Each BrS patient will be followed up prospectively for symptoms and AICD shock. Subsequently, the study will analyze relationship between genetic variants and clinical data against clinical severity of BrS patients.

Conditions

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Brugada Syndrome

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Case

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

No interventions assigned to this group

Control

Healthy volunteers without Brugada marker from ECG.

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

* 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

Exclusion Criteria

* 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
Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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National Research Council of Thailand

OTHER_GOV

Sponsor Role collaborator

Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

OTHER

Sponsor Role collaborator

Chulalongkorn University

OTHER

Sponsor Role lead

Responsible Party

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Apichai Khongphatthanayothin, MD

Professor of Pediatrics, Division of Pediatric Cardiology, Department of Pediatrics, Faculty of Medicine

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Koonlawee Nademanee, MD

Role: STUDY_CHAIR

Chulalongkorn University

Yong Poovorawan, MD

Role: STUDY_DIRECTOR

Chulalongkorn University

Apichai Khongphatthanayothin, MD

Role: PRINCIPAL_INVESTIGATOR

Chulalongkorn University

Locations

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Siriraj Hospital, Mahidol University

Bangkok Noi, Bangkok, Thailand

Site Status RECRUITING

Vajira Hospital

Dusit, Bangkok, Thailand

Site Status RECRUITING

Chulalongkorn University

Pathum Wan, Bangkok, Thailand

Site Status RECRUITING

Faculty of Medicine Ramathibodi Hospital, Mahidol University

Ratchathewi, Bangkok, Thailand

Site Status RECRUITING

Bhumibol Adulyadej RTAF Hospital

Sai Mai, Bangkok, Thailand

Site Status RECRUITING

Bumrungrad International Hospital

Vadhana, Bangkok, Thailand

Site Status RECRUITING

Pacific Rim Electrophysiology Research Institute Data Coordinating Center

Vadhana, Bangkok, Thailand

Site Status RECRUITING

Bangkok Hospital

Bangkok, , Thailand

Site Status RECRUITING

Faculty of Medicine, Chiang Mai University

Chiang Mai, , Thailand

Site Status RECRUITING

Queen Sirikit Heart Center of the Northeast

Khon Kaen, , Thailand

Site Status RECRUITING

Central Chest Hospital

Nonthaburi, , Thailand

Site Status RECRUITING

Countries

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Thailand

Central Contacts

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Apichai Khongphatthanayothin, MD

Role: CONTACT

66891555545

Pharawee Wandee, BSc

Role: CONTACT

66944174331

Facility Contacts

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Rungroj Krittayaphong, MD

Role: primary

66818059992

Thaveekiat Vasavakul, MD

Role: primary

66814515421

Apichai Khongphatthanayothin, MD

Role: primary

66891555545

Pharawee Wandee, BSc

Role: backup

66944174331

Tachapong Ngamukos, MD

Role: primary

66819241527

Gumpanart Veetakul, MD

Role: primary

Koonlawee Nademanee, MD

Role: primary

66870708787

Koonlawee Nademanee, MD

Role: primary

66870708787

Apichai Khongphatthanayothin, MD

Role: primary

66891555545

Wanwarang Wongcharoen, MD

Role: primary

66897001604

Pattarapong Makarawate, MD

Role: primary

66816614751

Alisara Anannab, MD

Role: primary

66819380010

References

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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.

Reference Type RESULT
PMID: 22294707 (View on PubMed)

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.

Reference Type RESULT
PMID: 24011539 (View on PubMed)

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.

Reference Type RESULT
PMID: 9355899 (View on PubMed)

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.

Reference Type RESULT
PMID: 23872634 (View on PubMed)

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.

Reference Type DERIVED
PMID: 34092119 (View on PubMed)

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.

Reference Type DERIVED
PMID: 32619740 (View on PubMed)

Related Links

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Other Identifiers

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2558-114

Identifier Type: -

Identifier Source: org_study_id

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