12-lead Holter monitoring for the detection of Brugada Syndrome.
Research type
Research Study
Full title
Can 12-lead Holter monitoring facilitate the detection of the Brugada Syndrome ECG pattern and reduce the use of Ajmaline challenges?
IRAS ID
168236
Contact name
Luigi Venetucci
Contact email
Sponsor organisation
Manchester University Foundation Trust
Clinicaltrials.gov Identifier
N/A, N/A
Duration of Study in the UK
0 years, 6 months, 30 days
Research summary
This project aims to use 12-lead 24-hour electrocardiogram (ECG) monitoring, also known as 12-lead Holter monitoring to investigate patients with suspected or confirmed Brugada Syndrome (BrS), a genetic arrhythmia (abnormal heart rhythm) syndrome which predisposes patients to sudden cardiac death. Currently, patients suspected to have BrS, but who do not meet the diagnostic criteria on the ECG, a trace of the heart’s rhythm, undergo a drug challenge with a sodium channel blocker – commonly ajmaline in the UK, whilst their ECG is monitored. However, this investigation carries the risk of inducing a lethal arrhythmia; therefore, non-invasive methods of monitoring may be more appropriate for the diagnosis of BrS. Patients over 18 years of age attending the Genetic Arrhythmia Service, who have undergone ajmaline challenge as part of investigations for evidence of Brugada Syndome will be eligible for the study. The study will investigate patients who have undergone ajmaline challenge where the result has been either positive (this is defined by the visualisation of a Type 1 BrS pattern on the ECG) or negative. The 12-lead Holter monitor will be fitted in a modified position, with all six precordial leads being placed on the right and left parasternal borders, in the 4th, 3rd and 2nd intercostal spaces, respectively – high positioning of right precordial leads has been found to be more sensitive for the BrS ECG pattern. By monitoring patients after they have undergone an ajmaline challenge, the aim is to determine the number of these tests which can be prevented by the use of 12-lead Holter monitoring, and determine the sensitivity of the Holter monitor for detecting BrS. On the basis of ethical approval being obtained by the end of April 2015, the study is expected to last for 11 months.
REC name
North West - Greater Manchester East Research Ethics Committee
REC reference
15/NW/0251
Date of REC Opinion
1 Jun 2015
REC opinion
Further Information Favourable Opinion