Mobile Electrocardiogram Monitoring for Detecting Arrhythmias in Children

August 29, 2023 updated by: Antonio Berruezo, MD, PhD, Centro Medico Teknon

Effectiveness of Mobile Electrocardiogram Monitoring for Detecting Arrhythmias in Children With Symptoms: A Randomized Clinical Trial

The objective of this project is to evaluate the capability of a specific mobile electrocardiogram monitoring of detecting arrhythmic events in children with history of palpitation and or syncope. We will compare this approach with the standard approach of clinical follow-up plus 24-hour Holter ECG monitoring in terms of acceptability and ability to identify significant arrhythmias.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Syncope and palpitation are one of the most common referrals to pediatric cardiology in patients with and without structural heart disease. In children with palpitation supraventricular tachycardia (SVT) is the most common final diagnosis. While some SVTs caused by the presence of an accessory pathway are highly recommend to be treated, other forms of arrhythmia are rarely life threatening and therapy depends on the burden of symptoms. Some SVT can be the first manifestation of an underlying heart disease. Early onset of atrial fibrillation, for example, in childhood usually reveals a genetic pathology and therefore needs further investigation. Besides the need for precise diagnosis to choose adequate management and therapy, unrecognized paroxysmal SVT have shown to lead to misdiagnosis mimicking symptoms of a psychiatric disorder. However, with the current diagnostic tools and protocols in only 10 % to 15 % of children with palpitation an underlying arrhythmia is found.

Syncope commonly is of benign character in children but it can be the first warning sign of a serious condition. Despite considerable testing and expense accurate diagnosis of the underlying cause of syncope is still challenging. The theoretical possibility of an underlying fatal arrhythmia adds remarkable to the mental health challenges of adolescence and the families. Sudden cardiac death (SCD) is a rare but devastating event in children and adolescents.

Syncope and palpitation deserve even higher attention in patients with congenital heart disease (CHD). These patients have an overall higher risk of developing cardiac arrhythmias as consequence of the pre-existing anatomical alterations, as well as the surgical treatment necessary for its correction. In many cases arrhythmia occur earlier in life and sometimes SCD is the first symptom of manifestation.

To study the origin of palpitation and syncope 12 lead electrocardiogram (ECG) and 24-hours Holter monitoring is typically performed. In case of high clinical suspicion, implantable loop-recorder and electrophysiological study can be performed to finally reach a diagnosis. However, it is an invasive test that is thought to be avoided in children if possible and might be poorly tolerated in patients with CHD.

In recent years, technological development has allowed the validation of different tools for detection of arrhythmias by "smart" devices. The "KARDIA" Mobile Cardiac Monitor is a handheld ECG device that enables users to collect and store single-channel ECG recordings using the smart phone, smart watch, or tablet. A recent study has demonstrated the efficacy of this device in the early diagnosis of arrhythmic disorders in adults by performing ECGs twice weekly plus additional ECG if symptomatic. However, its utility for the early detection and diagnosis of arrhythmias in children and patients with a CHD, which have a different normal physiology of the heart rhythm, has not yet been studied.

Study Type

Interventional

Enrollment (Estimated)

84

Phase

  • Not Applicable

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 Locations

  • Spain
      • Barcelona, Spain, 08022
        • Recruiting
        • Centro Médico Teknon
        • Principal Investigator:
          • Antonio Berruezo, MD, PhD
        • Contact:
        • Sub-Investigator:
          • Diego Penela, MD, PhD
        • Sub-Investigator:
          • Claudia Scherer, MD

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

5 years to 18 years (Child, Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Age between 5-18 years old with or without the diagnosis of structural heart disease and symptoms suggestive of rhythm disorders as follows: palpitations and/or syncope and/or dizziness.
  • 24-hours Holter without diagnosis of arrhythmia.
  • Having an smart phone, smart watch, or tablet (the patient itself or a family member who lives together with the patient) compatible with KARDIA mobile ECG monitoring.
  • Signed informed consent. In cases under the age of <18 y.o informed consent should be signed by parents or guardians.

Exclusion Criteria:

  • Concomitant investigation treatments.
  • Being already diagnosed for arrhythmic events.
  • Medical, geographical and social factors that make study participation impractical, and inability to give written informed consent.
  • Patient's refusal to participate in the study.

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

  • Primary Purpose: Diagnostic
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: 24-hour Holter monitoring
Standard care with clinical follow-up plus repeating 24-hours Holter ECG (month 1, 6, 12)
Experimental: Mobile ECG Monitoring
Standard care with clinical follow-up plus Mobile ECG Monitoring.
Diagnostic test: KARDIA Mobile ECG Monitoring (KMCM)
The KMCM will be introduced to the patient of the KMCM arm in the outpatient clinic. The activation and configuration will be done together with the physician in the outpatient clinic (installation of the ECG app, enabling heart rate rhythm notification). Patients are requested to acquired ECGs twice weekly plus additional ECGs if symptomatic. In case of symptoms the patient is asked to generate an ECG and communicate the event timely to the investigator and to the treating physician by sending a report through the ECG app. An e-mail account created for the study will be checked at least once a day. The arrhythmia diagnosis will be performed by the clinician based on the ECG information, independently of the arrhythmia classification automatically performed by the device. In case of stronger symptoms of any kind at any time the patient is asked to request medical help regardless of the KMCM notifications. Change of management will be collected.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Time to a documented new arrhythmia.
Time Frame: 12 months
Time to a documented new arrhythmia counting time from the inclusion date.
12 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Incidence of medical request
Time Frame: 12 months
Rate of patients with changes of diagnostic and/or therapy
12 months
Hospitalization during study time.
Time Frame: 12 months
Number of participants hospitalized during study time
12 months

Collaborators and Investigators

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

Sponsor

Centro Medico Teknon

Investigators

  • Principal Investigator: Antonio Berruezo, MD, PhD, Centro Médico Teknon

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)

April 7, 2021

Primary Completion (Estimated)

April 30, 2024

Study Completion (Estimated)

August 30, 2024

Study Registration Dates

First Submitted

August 8, 2021

First Submitted That Met QC Criteria

November 28, 2021

First Posted (Actual)

December 1, 2021

Study Record Updates

Last Update Posted (Estimated)

August 31, 2023

Last Update Submitted That Met QC Criteria

August 29, 2023

Last Verified

August 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SMART-CHILD

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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