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

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
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

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.
  • 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Chulalongkorn University

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
National Research Council of Thailand

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 28, 2016

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
January 1, 2021

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
January 1, 2023

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 13, 2020

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 14, 2020

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
January 18, 2020

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
January 18, 2020

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 14, 2020

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
January 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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