Optimizing Diagnostics Of Syncope Events Using Intelligent Telemetric Solutions.
TELEMARC3
Optimizing Diagnostics And Therapy Of Arrhythmia And Syncope Events Using Intelligent Telemetric Solutions. Diagnostics Of Syncope In Children.
1 other identifier
interventional
640
1 country
2
Brief Summary
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 syncope in comparison with standard diagnostic procedure
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Feb 2011
Typical duration for not_applicable
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
December 22, 2010
CompletedFirst Posted
Study publicly available on registry
December 23, 2010
CompletedStudy Start
First participant enrolled
February 1, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2013
CompletedDecember 5, 2011
December 1, 2011
1.8 years
December 22, 2010
December 2, 2011
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Recording of symptomatic or life threatening arrhythmia event
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 Outcomes (2)
Occurrence of silent (asymptomatic) arrhythmia event
within 30 days since the start of monitoring
1. Verification of patient self assessment based on the Quality of Life questionnaire and EHRA scale against evidence of cardiac arrhythmia occurrence
within 30 days since the start of monitoring
Study Arms (2)
Telemetric ECG monitoring
EXPERIMENTALTelemetric Full Disclosure ECG monitoring
24 hours standard Holter monitoring
EXPERIMENTALInterventions
repeated 24 hours ECG Holter monitoring
Telemetric ECG full disclosure monitoring with GSM technology
Eligibility Criteria
You may qualify if:
- History of syncope
- 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
You may not qualify if:
- Syncope with known underlying disease
- Inability to operate the telemetric device at home
- Complete Heart block
- QT\>500ms
- Implantation of ICD
- Inability to comply with the study protocol
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
Medical University of Warsaw Department of Pediatric Cardiology and General Pediatrics
Warsaw, 00-576, Poland
The Children's Memmorial Health Institute
Warsaw, 04-730, Poland
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Lukasz Szumowski, Prof. MD PhD
National Institute of Cardiology, Warsaw, Poland
- PRINCIPAL INVESTIGATOR
Katarzyna Bieganowska, Prof. MD PhD
Children's Memorial Health Institute
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- DIAGNOSTIC
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
December 22, 2010
First Posted
December 23, 2010
Study Start
February 1, 2011
Primary Completion
December 1, 2012
Study Completion
January 1, 2013
Last Updated
December 5, 2011
Record last verified: 2011-12