Optimizing Diagnostics Of Syncope Events Using Intelligent Telemetric Solutions. (TELEMARC3)

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

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

Study Overview

• Status: Unknown
• Conditions: Cardiac Arrhythmia; Cardiogenic Syncope
• Intervention / Treatment: Device: Telemetric ECG monitoring; Device: repeated 24 hours ECG Holter monitoring

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 Type: Interventional
• Enrollment (Anticipated): 640
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Katarzyna Bieganowska, Prof. MD PhD; Email: kbieganowska@wp.pl
• Study Contact Backup: Name: Maria Miszczak-Knecht, MD, PhD; Email: mmknecht@neostrada.pl

Study Locations

• Poland
  • Warsaw, Poland, 00-576
    • Recruiting
    • Medical University of Warsaw Department of Pediatric Cardiology and General Pediatrics
    • Contact: Bożena Werner, MD PhD; Phone Number: (+48 22) 629 83 17; Email: kardiologia@litewska.edu.pl
    • Principal Investigator: Bożena Werner, MD PhD
    • Sub-Investigator: Tomasz Florianczyk, MD
  • Warsaw, Poland, 04-730
    • Recruiting
    • The Children's Memmorial Health Institute
    • Contact: Maria Miszczak-Knecht, MD PhD; Email: mmknecht@neostrada.pl
    • Sub-Investigator: Maria Miszczak-Knecht, MD, PhD
    • Contact: Katarzyna Bieganowska, MD PhD; Email: kbieganowska@wp.pl
    • Principal Investigator: Katarzyna Bieganowska, Prof.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: No older than 16 years (Child, Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 24 hours standard Holter monitoring	Device: repeated 24 hours ECG Holter monitoring; repeated 24 hours ECG Holter monitoring
Experimental: Telemetric ECG monitoring; Telemetric Full Disclosure ECG monitoring	Device: Telemetric ECG monitoring; Telemetric ECG full disclosure monitoring with GSM technology

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Secondary Outcome Measures

Outcome 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

Collaborators and Investigators

• Sponsor: Institute of Cardiology, Warsaw, Poland
• Investigators: Study Chair: Lukasz Szumowski, Prof. MD PhD, Institute of Cardiology, Warsaw, Poland; Principal Investigator: Katarzyna Bieganowska, Prof. MD PhD, Children's Memorial Health Institute

Study record dates

Study Major Dates

• Study Start: February 1, 2011
• Primary Completion (Anticipated): December 1, 2012
• Study Completion (Anticipated): January 1, 2013

Study Registration Dates

• First Submitted: December 22, 2010
• First Submitted That Met QC Criteria: December 22, 2010
• First Posted (Estimate): December 23, 2010

Study Record Updates

• Last Update Posted (Estimate): December 5, 2011
• Last Update Submitted That Met QC Criteria: December 2, 2011
• Last Verified: December 1, 2011

More Information

Terms related to this study

• Keywords: Children; Pediatrics; Cardiac arrhythmia; Cardiogenic syncope
• Additional Relevant MeSH Terms: Pathologic Processes; Heart Diseases; Cardiovascular Diseases; Nervous System Diseases; Neurologic Manifestations; Neurobehavioral Manifestations; Unconsciousness; Consciousness Disorders; Arrhythmias, Cardiac; Syncope
• Other Study ID Numbers: UDAPOIG.01.03.01-00-068/09-00C