Back to results

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

Primary Purpose

Cardiac Arrhythmia, Cardiogenic Syncope

Status

Unknown status

Phase

Not Applicable

Locations

Poland

Study Type

Interventional

Intervention

repeated 24 hours ECG Holter monitoring

Telemetric ECG monitoring

About this trial

This is an interventional diagnostic trial for Cardiac Arrhythmia focused on measuring Cardiac arrhythmia, Cardiogenic syncope, Pediatrics, Children

Eligibility Criteria

undefined - 18 Years (Child, Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Medical University of Warsaw Department of Pediatric Cardiology and General PediatricsRecruiting
The Children's Memmorial Health InstituteRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Arm Label

Telemetric ECG monitoring

24 hours standard Holter monitoring

Arm Description

Telemetric Full Disclosure ECG monitoring

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Occurrence of silent (asymptomatic) arrhythmia event

1. Verification of patient self assessment based on the Quality of Life questionnaire and EHRA scale against evidence of cardiac arrhythmia occurrence

Full Information

NCT ID

NCT01265290

First Posted

December 22, 2010

Last Updated

December 2, 2011

Sponsor

National Institute of Cardiology, Warsaw, Poland

1. Study Identification

Unique Protocol Identification Number

NCT01265290

Brief Title

Optimizing Diagnostics Of Syncope Events Using Intelligent Telemetric Solutions.

Acronym

TELEMARC3

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

December 2011

Overall Recruitment Status

Unknown status

Study Start Date

February 2011 (undefined)

Primary Completion Date

December 2012 (Anticipated)

Study Completion Date

January 2013 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor

National Institute of Cardiology, Warsaw, Poland

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Cardiac Arrhythmia, Cardiogenic Syncope

Keywords

Cardiac arrhythmia, Cardiogenic syncope, Pediatrics, Children

7. Study Design

Primary Purpose

Diagnostic

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

640 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Telemetric ECG monitoring

Arm Type

Experimental

Arm Description

Telemetric Full Disclosure ECG monitoring

Arm Title

24 hours standard Holter monitoring

Arm Type

Experimental

Intervention Type

Device

Intervention Name(s)

repeated 24 hours ECG Holter monitoring

Intervention Description

repeated 24 hours ECG Holter monitoring

Intervention Type

Device

Intervention Name(s)

Telemetric ECG monitoring

Intervention Description

Telemetric ECG full disclosure monitoring with GSM technology

Primary Outcome Measure Information:

Title

Recording of symptomatic or life threatening arrhythmia event

Description

Time Frame

within 30 days since the start of monitoring

Secondary Outcome Measure Information:

Title

Occurrence of silent (asymptomatic) arrhythmia event

Time Frame

within 30 days since the start of monitoring

Title

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

10. Eligibility

Sex

All

Maximum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility 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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Katarzyna Bieganowska, Prof. MD PhD

kbieganowska@wp.pl

First Name & Middle Initial & Last Name or Official Title & Degree

Maria Miszczak-Knecht, MD, PhD

mmknecht@neostrada.pl

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Lukasz Szumowski, Prof. MD PhD

Organizational Affiliation

National Institute of Cardiology, Warsaw, Poland

Official's Role

Study Chair

First Name & Middle Initial & Last Name & Degree

Katarzyna Bieganowska, Prof. MD PhD

Organizational Affiliation

Children's Memorial Health Institute

Official's Role

Principal Investigator

Facility Information:

Facility Name

Medical University of Warsaw Department of Pediatric Cardiology and General Pediatrics

City

Warsaw

ZIP/Postal Code

00-576

Country

Poland

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Bożena Werner, MD PhD

Phone

(+48 22) 629 83 17

kardiologia@litewska.edu.pl

First Name & Middle Initial & Last Name & Degree

Bożena Werner, MD PhD

First Name & Middle Initial & Last Name & Degree

Tomasz Florianczyk, MD

Facility Name

The Children's Memmorial Health Institute

City

Warsaw

ZIP/Postal Code

04-730

Country

Poland

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Katarzyna Bieganowska, MD PhD

kbieganowska@wp.pl

First Name & Middle Initial & Last Name & Degree

Maria Miszczak-Knecht, MD PhD

mmknecht@neostrada.pl

First Name & Middle Initial & Last Name & Degree

Katarzyna Bieganowska, Prof.

First Name & Middle Initial & Last Name & Degree

Maria Miszczak-Knecht, MD, PhD

12. IPD Sharing Statement

Learn more about this trial

Optimizing Diagnostics Of Syncope Events Using Intelligent Telemetric Solutions.

We'll reach out to this number within 24 hrs