Unmasking Concealed Arrhythmia Syndromes

NCT06988189 | Recruiting

• 1 other identifier: REC 24/NS/0032
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Brugada ECG Patterns; Brugada Syndrome (BrS)

Keywords

Brugada syndrome; Ambulatory ECG; Wearable ECG; Long term continuous monitoring; AI ECG

Outcome Measures

Primary Outcomes (3)

• 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

Study Arms (3)

Healthy volunteers

Volunteer participants with no cardiac structural or arrhythmic conditions.

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

Manifest Arrhythmia Syndrome

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

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

Concealed Arrhythmia Syndrome

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

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

Interventions

12-lead ECG DIAGNOSTIC_TEST

12-lead ECG from a conventional ECG machine

Concealed Arrhythmia Syndrome; Healthy volunteers; Manifest Arrhythmia Syndrome

Continuous long term ambulatory ECG monitoring DIAGNOSTIC_TEST

Continuous long term ambulatory ECG monitoring using wearable ECG or cardiac monitor

Concealed Arrhythmia Syndrome; Healthy volunteers; Manifest Arrhythmia Syndrome

Ultra-high-frequency ECG DIAGNOSTIC_TEST

Ultra-high-frequency ECG acquired using specific acquisition equipment

Concealed Arrhythmia Syndrome; Healthy volunteers; Manifest Arrhythmia Syndrome

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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.

You may qualify if:

• Adults willing to take part
• Able to give consent

You may not qualify if:

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

Sponsors & Collaborators

• Imperial College London: lead

Study Sites (1)

Imperial College Healthcare NHS Trust

London, W12 0NN, United Kingdom

RECRUITING

Related Publications (1)

• 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.

  PMID: 28528724 BACKGROUND

MeSH Terms

Conditions

Brugada Syndrome

Interventions

Electrocardiography

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Cardiac Conduction System Disease; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Intervention Hierarchy (Ancestors)

Heart Function Tests; Diagnostic Techniques, Cardiovascular; Diagnostic Techniques and Procedures; Diagnosis; Electrodiagnosis

Study Officials

• Zachary Whinnett, PhD

  Imperial College London

  STUDY CHAIR

Central Study Contacts

Keenan Saleh, MBBS

CONTACT

+442033132243; keenan.saleh10@imperial.ac.uk

Ahran Arnold, PhD

CONTACT

+442033132243; ahran.arnold@imperial.ac.uk

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 8, 2025
• First Posted: May 23, 2025
• Study Start: September 9, 2024
• Primary Completion (Estimated): November 1, 2026
• Study Completion (Estimated): November 1, 2026
• Last Updated: May 23, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)