Optimizing Diagnostics Of Syncope Events Using Intelligent Telemetric Solutions. (TELEMARC3)
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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 syncope in comparison with standard diagnostic procedure
| Condition | Intervention |
|---|---|
|
Cardiac Arrhythmia Cardiogenic Syncope |
Device: repeated 24 hours ECG Holter monitoring Device: Telemetric ECG 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 Syncope 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 ]
- 1. Verification of patient self assessment based on the Quality of Life questionnaire and 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: | 640 |
| 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: Telemetric ECG monitoring
Telemetric Full Disclosure ECG monitoring
|
Device: Telemetric ECG monitoring
Telemetric ECG full disclosure monitoring with GSM technology
|
| Experimental: 24 hours standard Holter monitoring |
Device: repeated 24 hours ECG Holter monitoring
repeated 24 hours ECG Holter monitoring
|
Detailed Description:
Syncope can be caused by many conditions, often benign but in some cases syncope can be a symptom of severe arrhythmia. Early diagnosis of the underlying disease is very important to identify patients with severe cardiac arrhythmia to commence adequate treatment. 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 adequate 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 syncope
- Ability to operate the telemetric device at home
- Exclusion of underlying neurological disease
- informed consent undersigned by the parents
- informed consent undersigned by the child if over 16 years of age
Exclusion Criteria:
- 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
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, 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 | |
| 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: | NCT01265290 History of Changes |
| Other Study ID Numbers: | UDAPOIG.01.03.01-00-068/09-00C |
| Study First Received: | December 22, 2010 |
| Last Updated: | December 2, 2011 |
| Health Authority: | Poland: Ethics Committee |
Keywords provided by Institute of Cardiology, Warsaw, Poland:
|
Cardiac arrhythmia Cardiogenic syncope Pediatrics Children |
Additional relevant MeSH terms:
|
Arrhythmias, Cardiac Syncope Heart Diseases Cardiovascular Diseases Pathologic Processes Unconsciousness |
Consciousness Disorders Neurobehavioral Manifestations Neurologic Manifestations Nervous System Diseases Signs and Symptoms |
ClinicalTrials.gov processed this record on May 19, 2013