Optimizing Diagnostics Of Syncope Events Using Intelligent Telemetric Solutions.

Cardiac Arrhythmia Clinical Trial

— TELEMARC3  

Official title:

Optimizing Diagnostics And Therapy Of Arrhythmia And Syncope Events Using Intelligent Telemetric Solutions. Diagnostics Of Syncope In Children.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01265290
• Other study ID #: UDAPOIG.01.03.01-00-068/09-00C
• Status: Recruiting
• Phase: N/A
• First received: December 22, 2010
• Last updated: December 2, 2011
• Start date: February 2011
• Est. completion date: January 2013

Study information

• Verified date: December 2011
• Source: Institute of Cardiology, Warsaw, Poland
• Contact: Katarzyna Bieganowska, Prof. MD PhD
• Email: kbieganowska[@]wp.pl
• Is FDA regulated: No
• Health authority: Poland: Ethics Committee
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 640
• Est. completion date: January 2013
• Est. primary completion date: December 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A to 18 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Arrhythmias, Cardiac
• Cardiac Arrhythmia
• Cardiogenic Syncope
• Syncope

Intervention

Device:
• repeated 24 hours ECG Holter monitoring
repeated 24 hours ECG Holter monitoring
• Telemetric ECG monitoring
Telemetric ECG full disclosure monitoring with GSM technology

Locations

Country	Name	City	State
Poland	Medical University of Warsaw Department of Pediatric Cardiology and General Pediatrics	Warsaw
Poland	The Children's Memmorial Health Institute	Warsaw

Sponsors (1)

Lead Sponsor	Collaborator
Institute of Cardiology, Warsaw, Poland

Country where clinical trial is conducted

Poland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	Occurrence of silent (asymptomatic) arrhythmia event		within 30 days since the start of monitoring	No
Secondary	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	No