Unmasking Concealed Arrhythmia Syndromes (UCAS)

Imperial College London

Status: Enrolling

Conditions: Brugada Syndrome (BrS); Brugada ECG Patterns

Treatments: Diagnostic Test: Continuous long term ambulatory ECG monitoring; Diagnostic Test: 12-lead ECG; Diagnostic Test: Ultra-high-frequency ECG

Study type: Observational

Funder types: Other

Identifiers

NCT06988189

REC 24/NS/0032

Details and patient eligibility

About

This study seeks to evaluate whether using non-invasive electrocardiograph (ECG) techniques, including long term ECG monitoring with wearable ECGs, can improve the detection of concealed Brugada syndrome.

Full description

Application of long term continuous ECG monitoring via ECG wearables and ambulatory ECG monitors to detect manifestations of Brugada syndrome. This approach will be combined with development of an AI (artificial intelligence) enabled ECG platform to automate Brugada ECG detection and analysis.

The protocol will comprise the following parts:

Study A: Brugada ECG AI development. This will automate the recognition of the type 1 Brugada ECG pattern on 12 lead ECGs.

Study B: Remote arrhythmia diagnostics. A prospective observational study whereby recruited participants will be fitted with a wearable ECG or cardiac monitor to undergo continuous long term ambulatory ECG monitoring. The algorithms developed in study A will be applied to long term ECG data captured in this study.

Study C: Arrhythmic risk stratification using ultra-high-frequency ECG. This exploratory study will look for markers of arrhythmic risk in patients with manifest and concealed arrhythmia syndromes.

Enrollment: 200 estimated patients

Sex: All

Ages: 18 to 100 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Adults willing to take part
• Able to give consent

Exclusion criteria

• Unable to give consent
• Children age < 18 years and adults > 100 years old

Trial design

200 participants in 3 patient groups

Healthy volunteers

Description:

Volunteer participants with no cardiac structural or arrhythmic conditions.

Treatment:

Diagnostic Test: Ultra-high-frequency ECG

Diagnostic Test: 12-lead ECG

Diagnostic Test: Continuous long term ambulatory ECG monitoring

Manifest Arrhythmia Syndrome

Description:

Manifest arrhythmia syndrome patients (patients with an arrhythmic syndrome with an abnormal ECG)

Treatment:

Diagnostic Test: Ultra-high-frequency ECG

Diagnostic Test: 12-lead ECG

Diagnostic Test: Continuous long term ambulatory ECG monitoring

Concealed Arrhythmia Syndrome

Description:

Concealed arrhythmia syndrome patients (patients with a normal ECG with a known underlying arrhythmic diagnosis)

Treatment:

Diagnostic Test: Ultra-high-frequency ECG

Diagnostic Test: 12-lead ECG

Diagnostic Test: Continuous long term ambulatory ECG monitoring