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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified December 2011 by Institute of Cardiology, Warsaw, Poland.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Institute of Cardiology, Warsaw, Poland
ClinicalTrials.gov Identifier:
NCT01265771
First received: December 22, 2010
Last updated: December 2, 2011
Last verified: December 2011
  Purpose

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.


Condition Intervention
Arrhythmia
Children
Device: Prolonged telemetric Full Disclosure ECG recording.
Device: Repeated 24 hours ECG Holter monitoring

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: Optimizing Diagnostics And Therapy Of Arrhythmia And Syncope Events Using Intelligent Telemetric Solutions. Diagnostics Of Arrhythmia In Children

Resource links provided by NLM:


Further study details as provided by Institute of Cardiology, Warsaw, Poland:

Primary Outcome Measures:
  • Recording of symptomatic or life threatening arrhythmia event [ Time Frame: within 30 days since the start of monitoring ] [ Designated as safety issue: No ]
    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


Secondary Outcome Measures:
  • Occurrence of silent (asymptomatic) arrhythmia event [ Time Frame: within 30 days since the start of monitoring ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]

Estimated Enrollment: 400
Study Start Date: February 2011
Estimated Study Completion Date: January 2013
Estimated Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: 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 Name: Pocket ECG, Medicalgorithmics

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

  Eligibility

Ages Eligible for Study:   up to 18 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01265771

Contacts
Contact: Katarzyna Bieganowska, Prof. MD PhD kbieganowska@wp.pl
Contact: Maria Miszczak-Knecht, MD PhD mmknecht@neostrada.pl

Locations
Poland
The Children's Memmorial Health Institute Recruiting
Warsaw, Poland, 04-730
Contact: Katarzyna Bieganowska, Prof. MD PhD       kbieganowska@wp.pl   
Contact: Maria Miszczak-Knecht, MD PhD       mmknecht@neostrada.pl   
Principal Investigator: Katarzyna Bieganowska, Prof         
Sub-Investigator: Maria Miszczak-Knecht, MD, PhD         
Institute of Cardiology Recruiting
Warsaw, Poland, 04-620
Contact: Lukasz Szumowski, Prof       lszumowski@ikard.pl   
Principal Investigator: Lukasz Szumowski, Prof         
Sub-Investigator: Zbigniew Jedynak, dr         
Medical University of Warsaw Department of Pediatric Cardiology and General Pediatrics Recruiting
Warsaw, Poland, 00-576
Contact: Bożena Werner, MD PhD    (+48 22) 629 83 17    kardiologia@litewska.edu.pl   
Principal Investigator: Bożena Werner, MD PhD         
Sub-Investigator: Tomasz Florianczyk, MD         
Sponsors and Collaborators
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
  More Information

No publications provided

Responsible Party: Prof. Lukasz Szumowski MD PhD, Institute of Cardiology, Warsaw
ClinicalTrials.gov Identifier: NCT01265771     History of Changes
Other Study ID Numbers: UDAPOIG.01.03.01-00-068/09-00B
Study First Received: December 22, 2010
Last Updated: December 2, 2011
Health Authority: Poland: Ethics Committee

Keywords provided by Institute of Cardiology, Warsaw, Poland:
Arrhythmia
Children

Additional relevant MeSH terms:
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes

ClinicalTrials.gov processed this record on April 17, 2014