Cardiac Arrhythmia, Cardiogenic Syncope
Conditions
Keywords
Cardiac arrhythmia, Cardiogenic syncope, Pediatrics, Children
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
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.
Interventions
repeated 24 hours ECG Holter monitoring
DEVICETelemetric ECG monitoring
Telemetric ECG full disclosure monitoring with GSM technology
Sponsors
National Institute of Cardiology, Warsaw, Poland
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
No minimum to 18 Years
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Recording of symptomatic or life threatening arrhythmia event | within 30 days since the start of monitoring | 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
| Measure | 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 | within 30 days since the start of monitoring |
Countries
Poland
Contacts
Primary ContactKatarzyna Bieganowska, Prof. MD PhD
Backup ContactMaria Miszczak-Knecht, MD, PhD
Outcome results
None listed