Clinical trial NCT01265290: Optimizing Diagnostics Of Syncope Events Using Intelligent Telemetric Solutions.
Official title: Optimizing Diagnostics And Therapy Of Arrhythmia And Syncope Events Using Intelligent Telemetric Solutions. Diagnostics Of Syncope In Children.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Cardiac Arrhythmia
Cardiogenic Syncope
Keywords: Cardiac arrhythmia
Cardiogenic syncope
Pediatrics
Children
Lead sponsor: National Institute of Cardiology, Warsaw, Poland
Sponsor class: OTHER
First posted: 2010-12-23
Enrollment: 640
Sex: ALL
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

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.

Eligibility criteria: 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

Primary outcomes:
measure: Recording of symptomatic or life threatening arrhythmia event
timeFrame: within 30 days since the start of monitoring
Secondary outcomes:
measure: Occurrence of silent (asymptomatic) arrhythmia event
timeFrame: within 30 days since the start of monitoring
measure: 1. Verification of patient self assessment based on the Quality of Life questionnaire and EHRA scale against evidence of cardiac arrhythmia occurrence
timeFrame: within 30 days since the start of monitoring
Other outcomes:
Locations:
city: Warsaw
country: Poland
facility: Medical University of Warsaw Department of Pediatric Cardiology and General Pediatrics
city: Warsaw
country: Poland
facility: The Children's Memmorial Health Institute
Study officials:
affiliation: National Institute of Cardiology, Warsaw, Poland
name: Lukasz Szumowski, Prof. MD PhD
role: STUDY_CHAIR
affiliation: Children's Memorial Health Institute
name: Katarzyna Bieganowska, Prof. MD PhD
role: PRINCIPAL_INVESTIGATOR
References: