Southeast Asian Brugada Syndrome Cohort

• Conditions: Brugada Syndrome

• Registration Number: NCT04232787
• Lead Sponsor: Chulalongkorn University

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.

Detailed Description

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.

Study Timeline

• Study Start: 2016-01-28
• Status Verified: 2020-01
• Study First Submitted: 2020-01-13
• Study First Submitted QC: 2020-01-14
• Last Update Submitted: 2020-01-14
• Study First Posted: 2020-01-18
• Last Update Posted: 2020-01-18
• Primary Completion: 2021-01
• Study Completion: 2023-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 750

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Relationship between genetic variants and Brugada syndrome (Brugada syndrome phenotype)	7 years	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.

Secondary Outcome Measures

Name	Time	Method
Natural history of Brugada syndrome (survival from arrhythmic events)	7 years	Cohort study to followed up BrS patients with or with arrhythmic events which assessed by survival curve analysis.
Epidemiology of Brugada syndrome	7 years	To study prevalence of Brugada syndrome in Thailand.

Trial Locations

Locations (11)

Siriraj Hospital, Mahidol University; 🇹🇭 Bangkok Noi, Bangkok, Thailand

Vajira Hospital; 🇹🇭 Dusit, Bangkok, Thailand

Chulalongkorn University; 🇹🇭 Pathum Wan, Bangkok, Thailand

Faculty of Medicine Ramathibodi Hospital, Mahidol University; 🇹🇭 Ratchathewi, Bangkok, Thailand

Bhumibol Adulyadej RTAF Hospital; 🇹🇭 Sai Mai, Bangkok, Thailand

Bumrungrad International Hospital; 🇹🇭 Watthana, Bangkok, Thailand

Pacific Rim Electrophysiology Research Institute Data Coordinating Center; 🇹🇭 Watthana, Bangkok, Thailand

Bangkok Hospital; 🇹🇭 Bangkok, Thailand

Faculty of Medicine, Chiang Mai University; 🇹🇭 Chiang Mai, Thailand

Queen Sirikit Heart Center of the Northeast; 🇹🇭 Khon Kaen, Thailand

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