Southeast Asian Brugada Syndrome Cohort (SEA-BrS)

January 14, 2020 updated by: Apichai Khongphatthanayothin, MD, Chulalongkorn University

Discovering the Genetic Causes of Brugada Syndrome in Thais and Southeast Asian Population

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.

Study Overview

Status

Recruiting

Conditions

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 Type

Observational

Enrollment (Anticipated)

750

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Apichai Khongphatthanayothin, MD
  • Phone Number: 66891555545
  • Email: apichaik@yahoo.com

Study Contact Backup

Study Locations

  • Thailand
      • Bangkok, Thailand, 10310
        • Recruiting
        • Bangkok hospital
        • Contact:
        • Principal Investigator:
          • Apichai Khongphatthanayothin, MD
      • Chiang Mai, Thailand, 50200
        • Recruiting
        • Faculty of Medicine, Chiang Mai University
        • Contact:
        • Principal Investigator:
          • Wanwarang Wongcharoen, MD
      • Khon Kaen, Thailand, 40002
        • Recruiting
        • Queen Sirikit Heart Center of The Northeast
        • Contact:
        • Principal Investigator:
          • Pattarapong Makarawate, MD
        • Sub-Investigator:
          • Dujdao Sahasatas, MD
      • Nonthaburi, Thailand, 11000
        • Recruiting
        • Central Chest Hospital
        • Contact:
        • Principal Investigator:
          • Alisara Anannab, MD
    • Bangkok
      • Bangkok Noi, Bangkok, Thailand, 10700
        • Recruiting
        • Siriraj Hospital, Mahidol University
        • Contact:
        • Principal Investigator:
          • Rungroj Krittayaphong, MD
      • Dusit, Bangkok, Thailand, 10300
        • Recruiting
        • Vajira Hospital
        • Contact:
        • Principal Investigator:
          • Thaveekiat Vasavakul, MD
      • Pathum Wan, Bangkok, Thailand, 10330
        • Recruiting
        • Chulalongkorn University
        • Contact:
        • Contact:
        • Sub-Investigator:
          • Somchai Prechawat, MD
        • Sub-Investigator:
          • Sanchai Payungporn, PhD
        • Sub-Investigator:
          • Duangdao Wichadakul, PhD
        • Sub-Investigator:
          • Natawut Nupairoj, PhD
        • Sub-Investigator:
          • Krerk Piromsopa, PhD
        • Sub-Investigator:
          • Saran Vardhanabhuti, PhD
        • Sub-Investigator:
          • Duangkamon Ittipcharoen, BSc
        • Sub-Investigator:
          • Nitinan Chimparlee, MD
        • Sub-Investigator:
          • John Mauleekoonphairoj, MSc
        • Sub-Investigator:
          • Boosamas Sutjaporn, BNS
        • Sub-Investigator:
          • Pharawee Wandee, BSc
      • Ratchathewi, Bangkok, Thailand, 10400
        • Recruiting
        • Faculty of Medicine Ramathibodi Hospital, Mahidol University
        • Contact:
        • Principal Investigator:
          • Tachapong Ngamukos, MD
        • Sub-Investigator:
          • Montawatt Amnueypol, MD
      • Sai Mai, Bangkok, Thailand, 10220
        • Recruiting
        • Bhumibol Adulyadej RTAF Hospital
        • Contact:
        • Principal Investigator:
          • Gumpanart Veetakul, MD
      • Watthana, Bangkok, Thailand, 10110
        • Recruiting
        • Bumrungrad International Hospital
        • Contact:
        • Principal Investigator:
          • Koonlawee Nademanee
      • Watthana, Bangkok, Thailand, 10110
        • Recruiting
        • Pacific Rim Electrophysiology Research Institute Data Coordinating Center
        • Contact:
        • Principal Investigator:
          • Koonlawee Nademanee, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Thai Brugada syndrome patients and healthy volunteers

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Case
Thai patients with diagnosed Brugada syndrome by confirmed Brugada type 1 ECG.
Control
Healthy volunteers without Brugada marker from ECG.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Relationship between genetic variants and Brugada syndrome (Brugada syndrome phenotype)
Time Frame: 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.
7 years

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Chulalongkorn University

Collaborators

Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
National Research Council of Thailand

Investigators

  • Study Chair: Koonlawee Nademanee, MD, Chulalongkorn University
  • Study Director: Yong Poovorawan, MD, Chulalongkorn University
  • Principal Investigator: Apichai Khongphatthanayothin, MD, Chulalongkorn University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 28, 2016

Primary Completion (Anticipated)

January 1, 2021

Study Completion (Anticipated)

January 1, 2023

Study Registration Dates

First Submitted

January 13, 2020

First Submitted That Met QC Criteria

January 14, 2020

First Posted (Actual)

January 18, 2020

Study Record Updates

Last Update Posted (Actual)

January 18, 2020

Last Update Submitted That Met QC Criteria

January 14, 2020

Last Verified

January 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2558-114

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Yes

IPD Plan Description

Medical journals, abstract submissions and results database

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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