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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Healthy volunteers | Volunteer participants with no cardiac structural or arrhythmic conditions. |
| |
| Manifest Arrhythmia Syndrome | Manifest arrhythmia syndrome patients (patients with an arrhythmic syndrome with an abnormal ECG) |
| |
| Concealed Arrhythmia Syndrome | Concealed arrhythmia syndrome patients (patients with a normal ECG with a known underlying arrhythmic diagnosis) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 12-lead ECG | Diagnostic Test | 12-lead ECG from a conventional ECG machine |
|
| Measure | Description | Time Frame |
|---|---|---|
| Sensitivity, specificity, and area under the curve (AUC) of AI algorithm for detection of Brugada type 1 ECG pattern on 12-lead ECGs. | Assessment of performance and accuracy of AI ECG detection algorithm for type 1 Brugada ECG. | At completion of algorithm validation, approximately 12 months after study start |
| Detection rate of Brugada ECG pattern using extended-duration multi-electrode ambulatory ECG monitoring (wearable ECG) in patients with concealed Brugada syndrome. | AI ECG detection algorithm, developed in Study A, applied to full ECG recording to detect Type 1 Brugada ECG pattern. | Up to 12 months from enrolment |
| Number of cases of Brugada or Long QT Syndrome (LQTS) detected using extended-duration multi-electrode ambulatory ECG monitoring in patients with idiopathic ventricular fibrillation (VF), after application of AI ECG detection algorithms. | AI ECG detection algorithms applied to full ECG recording to detect Type 1 Brugada ECG pattern or LQTS unmasking. | Up to 12 months from enrolment |
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Inclusion Criteria:
Exclusion Criteria:
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Healthy volunteer controls, patients with a diagnosis of Brugada syndrome, patients with a diagnosis of idiopathic VF syndrome and patients with other inherited arrhythmogenic conditions.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Keenan Saleh, MBBS | Contact | +442033132243 | keenan.saleh10@imperial.ac.uk | |
| Ahran Arnold, PhD | Contact | +442033132243 | ahran.arnold@imperial.ac.uk |
| Name | Affiliation | Role |
|---|---|---|
| Zachary Whinnett, PhD | Imperial College London | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Imperial College Healthcare NHS Trust | Recruiting | London | W12 0NN | United Kingdom |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 28528724 | Background | Gray B, Kirby A, Kabunga P, Freedman SB, Yeates L, Kanthan A, Medi C, Keech A, Semsarian C, Sy RW. Twelve-lead ambulatory electrocardiographic monitoring in Brugada syndrome: Potential diagnostic and prognostic implications. Heart Rhythm. 2017 Jun;14(6):866-874. doi: 10.1016/j.hrthm.2017.02.026. |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Apr 2, 2024 | May 16, 2025 | Prot_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Apr 2, 2024 | May 16, 2025 | ICF_001.pdf |
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| ID | Term |
|---|---|
| D053840 | Brugada Syndrome |
| ID | Term |
|---|---|
| D001145 | Arrhythmias, Cardiac |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D000075224 | Cardiac Conduction System Disease |
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| ID | Term |
|---|---|
| D004562 | Electrocardiography |
| ID | Term |
|---|---|
| D006334 | Heart Function Tests |
| D003935 | Diagnostic Techniques, Cardiovascular |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
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| Continuous long term ambulatory ECG monitoring | Diagnostic Test | Continuous long term ambulatory ECG monitoring using wearable ECG or cardiac monitor |
|
| Ultra-high-frequency ECG | Diagnostic Test | Ultra-high-frequency ECG acquired using specific acquisition equipment |
|
| D030342 | Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D004568 | Electrodiagnosis |