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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
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Telemetric ECG monitoring | Experimental | Telemetric Full Disclosure ECG monitoring |
|
| 24 hours standard Holter monitoring | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| repeated 24 hours ECG Holter monitoring | Device | repeated 24 hours ECG Holter monitoring |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Katarzyna Bieganowska, Prof. MD PhD | Contact | kbieganowska@wp.pl | ||
| Maria Miszczak-Knecht, MD, PhD | Contact | mmknecht@neostrada.pl |
| Name | Affiliation | Role |
|---|---|---|
| Lukasz Szumowski, Prof. MD PhD | National Institute of Cardiology, Warsaw, Poland | Study Chair |
| Katarzyna Bieganowska, Prof. MD PhD | Children's Memorial Health Institute | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Medical University of Warsaw Department of Pediatric Cardiology and General Pediatrics | Recruiting | Warsaw | 00-576 | Poland |
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| ID | Term |
|---|---|
| D001145 | Arrhythmias, Cardiac |
| D013575 | Syncope |
| ID | Term |
|---|---|
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| Telemetric ECG monitoring | Device | Telemetric ECG full disclosure monitoring with GSM technology |
|
| within 30 days since the start of monitoring |
| The Children's Memmorial Health Institute | Recruiting | Warsaw | 04-730 | Poland |
|
| D014474 | Unconsciousness |
| D003244 | Consciousness Disorders |
| D019954 | Neurobehavioral Manifestations |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
| D012816 | Signs and Symptoms |