Pediatric Brugada Registry
Research type
Research Database
IRAS ID
262831
Contact name
M Cecilia Gonzalez Corcia
Contact email
Research summary
Pediatric Brugada Registry: A National Initiative for Risk Assessment and Management
REC name
South West - Central Bristol Research Ethics Committee
REC reference
19/SW/0139
Date of REC Opinion
24 Jan 2020
REC opinion
Further Information Favourable Opinion
Data collection arrangements
The following information will be collected from your healthcare records:
• Demographic Information (age, sex, ethnicity, etc.);
• Portions of your previous and current medical records that are relevant to this study, including but not limited to diagnosis(es), family and personal medical history and physical, laboratory and genetic studies, radiology studies and imaging, procedure results.
• Clinical presentation
• Acute medical management including diagnosis and treatment
• Follow up data: we will obtain specific data if you present with new or repetitive symptoms (syncope, SCD), or you present a change in the conduction parameters in your electrocardiogram, or you present with a shock from you defibrillator or with evidence of arrhythmias. Participating in this study will not change the way your doctor will diagnose, manage or treat you. You will not attend more clinical appointments, or perform an extra diagnostic test.
• Adverse events from both medications and ICDThe healthcare information will be given a unique study code number that will identify your research information. All of the personal information will be removed such as your name, healthcare number, address or social insurance number. This data will be copied into a separate research database housed at the Bristol Royal Hospital for Children and will be stored with password protection and only be accessed by the study staff.
Research programme
This study is designed to collect all of the healthcare information that relates to the expression of Brugada syndrome. The patient will be treated for your condition according to our normal methods. The patient will not have any special tests or procedures as part of this study. The study coordinator will collect information about the symptoms and electrical conduction of the heart for the registry, and the patient will be followed-up to see how you are doing for the first 5 years after entering the registry. Patients will be in the study for 5 years from the time of enrolment and we will collect information on a yearly basis during clinic visits during this time period. The result of this research will help identify risk makers and set a line of treatment in young patients with Brugada syndrome.
Research database title
Pediatric Brugada Registry: A National Initiative for Risk Assessment and Management
Establishment organisation
The University of Bristol
Establishment organisation address
Beacon House
Queen's Road
Bristol
BS8 1QU