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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified December 2011 by Institute of Cardiology, Warsaw, Poland.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Institute of Cardiology, Warsaw, Poland
ClinicalTrials.gov Identifier:
NCT01265290
First received: December 22, 2010
Last updated: December 2, 2011
Last verified: December 2011
  Purpose

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


Condition Intervention
Cardiac Arrhythmia
Cardiogenic Syncope
Device: repeated 24 hours ECG Holter monitoring
Device: Telemetric ECG monitoring

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: Optimizing Diagnostics And Therapy Of Arrhythmia And Syncope Events Using Intelligent Telemetric Solutions. Diagnostics Of Syncope In Children.

Resource links provided by NLM:


Further study details as provided by Institute of Cardiology, Warsaw, Poland:

Primary Outcome Measures:
  • Recording of symptomatic or life threatening arrhythmia event [ Time Frame: within 30 days since the start of monitoring ] [ Designated as safety issue: No ]
    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:
  • Occurrence of silent (asymptomatic) arrhythmia event [ Time Frame: within 30 days since the start of monitoring ] [ Designated as safety issue: No ]
  • 1. Verification of patient self assessment based on the Quality of Life questionnaire and EHRA scale against evidence of cardiac arrhythmia occurrence [ Time Frame: within 30 days since the start of monitoring ] [ Designated as safety issue: No ]

Estimated Enrollment: 640
Study Start Date: February 2011
Estimated Study Completion Date: January 2013
Estimated Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Telemetric ECG monitoring
Telemetric Full Disclosure ECG monitoring
Device: Telemetric ECG monitoring
Telemetric ECG full disclosure monitoring with GSM technology
Experimental: 24 hours standard Holter monitoring Device: repeated 24 hours ECG Holter monitoring
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.

  Eligibility

Ages Eligible for Study:   up to 18 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01265290

Contacts
Contact: Katarzyna Bieganowska, Prof. MD PhD kbieganowska@wp.pl
Contact: Maria Miszczak-Knecht, MD, PhD mmknecht@neostrada.pl

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

No publications provided

Responsible Party: Prof. Lukasz Szumowski MD PhD, Institute of Cardiology, Warsaw
ClinicalTrials.gov Identifier: NCT01265290     History of Changes
Other Study ID Numbers: UDAPOIG.01.03.01-00-068/09-00C
Study First Received: December 22, 2010
Last Updated: December 2, 2011
Health Authority: Poland: Ethics Committee

Keywords provided by Institute of Cardiology, Warsaw, Poland:
Cardiac arrhythmia
Cardiogenic syncope
Pediatrics
Children

Additional relevant MeSH terms:
Syncope
Arrhythmias, Cardiac
Unconsciousness
Consciousness Disorders
Neurobehavioral Manifestations
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Heart Diseases
Cardiovascular Diseases
Pathologic Processes

ClinicalTrials.gov processed this record on October 01, 2014