Optimizing Diagnostics Of Syncope Events Using Intelligent Telemetric Solutions.

Not Applicable

• Conditions: Cardiac Arrhythmia; Cardiogenic Syncope
• Interventions: Device: Telemetric ECG monitoring; Device: repeated 24 hours ECG Holter monitoring

• Registration Number: NCT01265290
• Lead Sponsor: National Institute of Cardiology, Warsaw, Poland

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.

Study Timeline

• Study First Submitted: 2010-12-22
• Study First Submitted QC: 2010-12-22
• Study First Posted: 2010-12-23
• Study Start: 2011-02
• Status Verified: 2011-12
• Last Update Submitted: 2011-12-02
• Last Update Posted: 2011-12-05
• Primary Completion: 2012-12
• Study Completion: 2013-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 640

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Telemetric ECG monitoring	Telemetric ECG monitoring	Telemetric Full Disclosure ECG monitoring
24 hours standard Holter monitoring	repeated 24 hours ECG Holter monitoring	-

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (2)

Medical University of Warsaw Department of Pediatric Cardiology and General Pediatrics; 🇵🇱 Warsaw, Poland

The Children's Memmorial Health Institute; 🇵🇱 Warsaw, Poland