Clinical trial NCT01265771: Optimizing Diagnostics Of Arrhythmia Events In Children Using Intelligent Telemetric Solutions
Official title: Optimizing Diagnostics And Therapy Of Arrhythmia And Syncope Events Using Intelligent Telemetric Solutions. Diagnostics Of Arrhythmia In Children
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Arrhythmia
Children
Keywords: Arrhythmia
Children
Lead sponsor: National Institute of Cardiology, Warsaw, Poland
Sponsor class: OTHER
First posted: 2010-12-23
Enrollment: 400
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 arrhythmia in comparison with standard diagnostic procedure.

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 criteria: 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

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: 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
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: Institute of Cardiology
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: