Optimizing Diagnostics Of Arrhythmia Events In Children Using Intelligent Telemetric Solutions (TELEMARC2)
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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 |
- 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
- 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 |
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| Contact: Katarzyna Bieganowska, Prof. MD PhD | kbieganowska@wp.pl | |
| Contact: Maria Miszczak-Knecht, MD PhD | mmknecht@neostrada.pl |
| 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 | |
| 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 June 18, 2013