Optimizing Diagnostics Of Arrhythmia Events In Children Using Intelligent Telemetric Solutions (TELEMARC2)

December 2, 2011 updated by: Institute of Cardiology, Warsaw, Poland

Optimizing Diagnostics And Therapy Of Arrhythmia And Syncope Events Using Intelligent Telemetric Solutions. Diagnostics Of Arrhythmia In Children

The purpose of this study is to assess efficacy of prolonged Full Disclosure electrocardiogram (ECG) monitoring and signal analysis using advanced telemetric technology to diagnose arrhythmia in comparison with standard diagnostic procedure.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

Irregular and/or rapid beating of the heart called heart palpitations can occur in individuals without heart disease and the reasons for their palpitations are unknown. Together with heart palpitations silent arrhythmia may be present that could lead to serious complications (eg. stroke). In others, palpitations result from heart rhythm disturbances, sometimes life threatening. Standard diagnostic methods such as 24 hours Holter electrocardiogram (ECG) monitoring or Event Holter do not guarantee early diagnosis of the arrhythmia. Prolonged heart rhythm recording and analysis using an automatic full disclosure telemetric device can increase probability of arrhythmia diagnosis and early administration of applicable treatment. Study patients will be diagnosed using standard Holter ECG monitoring, Event Holter or 30 days telemetric ECG monitoring. Efficacy of telemetric monitoring in diagnosis of cardiac arrhythmia will be assessed in comparison with the standard Holter monitoring and Event Holter

Study Type

Interventional

Enrollment (Anticipated)

400

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 Contact Backup

Study Locations

  • Poland
      • Warsaw, Poland, 00-576
        • Recruiting
        • Medical University of Warsaw Department of Pediatric Cardiology and General Pediatrics
        • Contact:
        • Principal Investigator:
          • Bożena Werner, MD PhD
        • Sub-Investigator:
          • Tomasz Florianczyk, MD
      • Warsaw, Poland, 04-620
        • Recruiting
        • Institute of Cardiology
        • Contact:
        • Sub-Investigator:
          • Zbigniew Jedynak, dr
      • Warsaw, Poland, 04-730
        • Recruiting
        • The Children's Memmorial Health Institute
        • Contact:
        • Contact:
        • Principal Investigator:
          • Katarzyna Bieganowska, Prof
        • Sub-Investigator:
          • Maria Miszczak-Knecht, MD, PhD

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

No older than 18 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • History of symptoms that can be potentially caused by cardiac arrhythmia occuring at least 4 times a year
  • Ability to operate the telemetric device at home
  • Informed consent undersigned by the parents
  • Informed consent undersigned by the child if over 16 years of age

Exclusion Criteria:

  • Previously recorded tachycardia evidence
  • Wolff Parkinson White syndrome
  • Inability to operate the telemetric device at home
  • Inability to comply with the study protocol

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
Experimental: Telemetry ordered by a Cardiologist
Device: Prolonged telemetric Full Disclosure ECG recording.
Thirty days Telemetric Full Disclosure ECG monitoring; subsequently analyzed in the Event Holter monitoring mode
Other Names:
  • Pocket ECG, Medicalgorithmics
Experimental: 24 hours standard Holter monitoring
Device: Repeated 24 hours ECG Holter monitoring
Repeated 24 hours ECG Holter monitoring
Experimental: Telemetry ordered by a Pediatrician
Device: Prolonged telemetric Full Disclosure ECG recording.
Thirty days Telemetric Full Disclosure ECG monitoring; subsequently analyzed in the Event Holter monitoring mode
Other Names:
  • Pocket ECG, Medicalgorithmics

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Recording of symptomatic or life threatening arrhythmia event
Time Frame: within 30 days since the start of monitoring
ECG monitoring is conducted until occurrence of symptomatic arrhythmia or life threatening arrhythmia but not longer than 30 days. Patients in the control group will have standard ECG Holter monitoring repeated twice
within 30 days since the start of monitoring

Secondary Outcome Measures

Outcome Measure
Time Frame
Occurrence of silent (asymptomatic) arrhythmia event
Time Frame: within 30 days since the start of monitoring
within 30 days since the start of monitoring
Verification of patient self assessment based on the Quality of Life questionnaire and European Heart Rhythm Association (EHRA) scale against evidence of cardiac arrhythmia occurrence
Time Frame: within 30 days since the start of monitoring
within 30 days since the start of monitoring

Collaborators and Investigators

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

Sponsor

Institute of Cardiology, Warsaw, Poland

Investigators

  • Study Chair: Lukasz Szumowski, Prof. MD PhD, Institute of Cardiology, Warsaw, Poland
  • Principal Investigator: Katarzyna Bieganowska, Prof. MD PhD, Children's Memorial Health Institute

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

February 1, 2011

Primary Completion (Anticipated)

December 1, 2012

Study Completion (Anticipated)

January 1, 2013

Study Registration Dates

First Submitted

December 22, 2010

First Submitted That Met QC Criteria

December 22, 2010

First Posted (Estimate)

December 23, 2010

Study Record Updates

Last Update Posted (Estimate)

December 5, 2011

Last Update Submitted That Met QC Criteria

December 2, 2011

Last Verified

December 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • UDAPOIG.01.03.01-00-068/09-00B

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

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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