Unmasking Concealed Arrhythmia Syndromes (UCAS)

May 16, 2025 updated by: Imperial College London
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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed 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.

Study Type

Observational

Enrollment (Estimated)

200

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

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.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Healthy volunteers
Volunteer participants with no cardiac structural or arrhythmic conditions.
Diagnostic test: 12-lead ECG
12-lead ECG from a conventional ECG machine
Diagnostic test: Continuous long term ambulatory ECG monitoring
Continuous long term ambulatory ECG monitoring using wearable ECG or cardiac monitor
Diagnostic test: Ultra-high-frequency ECG
Ultra-high-frequency ECG acquired using specific acquisition equipment
Manifest Arrhythmia Syndrome
Manifest arrhythmia syndrome patients (patients with an arrhythmic syndrome with an abnormal ECG)
Diagnostic test: 12-lead ECG
12-lead ECG from a conventional ECG machine
Diagnostic test: Continuous long term ambulatory ECG monitoring
Continuous long term ambulatory ECG monitoring using wearable ECG or cardiac monitor
Diagnostic test: Ultra-high-frequency ECG
Ultra-high-frequency ECG acquired using specific acquisition equipment
Concealed Arrhythmia Syndrome
Concealed arrhythmia syndrome patients (patients with a normal ECG with a known underlying arrhythmic diagnosis)
Diagnostic test: 12-lead ECG
12-lead ECG from a conventional ECG machine
Diagnostic test: Continuous long term ambulatory ECG monitoring
Continuous long term ambulatory ECG monitoring using wearable ECG or cardiac monitor
Diagnostic test: Ultra-high-frequency ECG
Ultra-high-frequency ECG acquired using specific acquisition equipment

What is the study measuring?

Primary Outcome Measures

Outcome Measure
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.
Time Frame: At completion of algorithm validation, approximately 12 months after study start
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.
Time Frame: Up to 12 months from enrolment
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.
Time Frame: Up to 12 months from enrolment
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Imperial College London

Investigators

  • Study Chair: Zachary Whinnett, PhD, Imperial College London

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 9, 2024

Primary Completion (Estimated)

November 1, 2026

Study Completion (Estimated)

November 1, 2026

Study Registration Dates

First Submitted

May 8, 2025

First Submitted That Met QC Criteria

May 16, 2025

First Posted (Actual)

May 23, 2025

Study Record Updates

Last Update Posted (Actual)

May 23, 2025

Last Update Submitted That Met QC Criteria

May 16, 2025

Last Verified

May 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • REC 24/NS/0032

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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