Telemetric Arrhythmia Diagnosis in Adults (TELEMARC1)

This study is currently recruiting participants. (see Contacts and Locations)
Verified February 2013 by Institute of Cardiology, Warsaw, Poland
Sponsor:
Information provided by:
Institute of Cardiology, Warsaw, Poland
ClinicalTrials.gov Identifier:
NCT01265758
First received: December 21, 2010
Last updated: February 18, 2013
Last verified: February 2013
  Purpose

The purpose of this study is to assess efficacy of prolonged Full Disclosure electrocardiogram (ECG) monitoring and signal analysis using advanced telemetric technology in comparison with a standard Holter ECG recording and an Event Holter recording to diagnose cardiac arrhythmia.


Condition Intervention
Atrial Fibrillation
Arrhythmia
Device: Prolonged telemetric Full Disclosure ECG recording.

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 - Evaluation of Arrhythmia Diagnostics in Adults

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: 14 days ] [ Designated as safety issue: No ]
    ECG monitoring is conducted until occurrence of symptomatic arrhythmia or life threatening arrhythmia but not longer than 14 days. Patients in the control group will have standard ECG Holter monitoring repeated 3 times unless arrhythmia is diagnosed earlier.


Secondary Outcome Measures:
  • Quality of Life questionnaire and European Heart Rhythm Association (EHRA) scale assessment against evidence of cardiac arrhythmia occurrence. [ Time Frame: 14 days ] [ Designated as safety issue: No ]
    Verification of patient self assessment based on the Quality of Life questionnaire and European Heart Rhythm Association (EHRA) scale against evidence of cardiac arrhythmia occurrence.

  • Silent (asymptomatic) arrhythmia events incidence detection assessment [ Time Frame: 14 days ] [ Designated as safety issue: No ]

    Evaluation of silent (asymptomatic) arrhythmia events incidence which potentially could cause serious complications

    1. Atrial fibrillation
    2. Atrial flutter
    3. Atrial Tachycardia
    4. Ventricular tachycardia

  • Evaluation of stroke and bleeding risk factors incidence [ Time Frame: 14 days ] [ Designated as safety issue: No ]
    Evaluation of stroke and bleeding risk factors incidence based on scores proposed in the European Society of Cardiology (ESC) guidelines: CHADS2VASC2 and HAS-BLED.


Estimated Enrollment: 360
Study Start Date: February 2011
Estimated Study Completion Date: March 2014
Estimated Primary Completion Date: March 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Telemetric ECG monitoring
Telemetric 14-days Full Disclosure ECG recording.
Device: Prolonged telemetric Full Disclosure ECG recording.
Continuous Full Disclosure Telemetric ECG monitoring lasting 14 days
Other Name: Medicalgorithmics, PocketECG
Active Comparator: Standard 24-hours Holter ECG recording
Standard 24-hours Holter ECG recording repeated 3 times unless arrhythmia is diagnosed earlier.
Device: Prolonged telemetric Full Disclosure ECG recording.
Continuous Full Disclosure Telemetric ECG monitoring lasting 14 days
Other Name: Medicalgorithmics, PocketECG

Detailed Description:

Irregular and/or rapid beating of the heart called heart palpitations can occur in individuals without heart disease and the reasons for their palpitations are unknown. Together with heart palpitations silent arrhythmia may be present that could lead to serious complications (eg. stroke). In others, palpitations result from heart rhythm disturbances, sometimes life threatening. Standard diagnostic methods such as 24 hours Holter 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 increase probability of arrhythmia diagnosis and early administration of applicable treatment. Study patients will be diagnosed using standard Holter ECG monitoring and 14 days telemetric full disclosure ECG monitoring. The full disclosure signal will be subsequently analyzed in the Event Monitoring mode by an independent consultant. Efficacy of Telemetric Monitoring in diagnosis of cardiac arrhythmia will be assessed in comparison with the standard Holter monitoring and Event Monitoring.

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Age - between 18 and 80 years old
  • History of symptoms potentially caused by arrhythmia
  • Symptoms occuring at least monthly
  • Patient informed consent
  • Declarative and feasible compliance (patient understands basic instructions regarding device use)

Exclusion Criteria:

  • Evidence of previously recorded arrhythmia
  • Inability to comply with the study protocol
  • Lack of patient cooperation
  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: NCT01265758

Contacts
Contact: Lukasz Szumowski, MD, PhD +48501152728 lszumowski@ikard.pl
Contact: Zbigniew Jedynak, MD, PhD +48603786780 zjedynak@ikard.pl

Locations
Poland
The Medical University of Gdańsk Recruiting
Gdansk, Poland, 80-210
Contact: Janusz Siebert, Prof. MD PhD       jsiebert@amg.gda.pl   
Principal Investigator: Janusz Siebert, Prof. MD PhD         
Institute of Cardiology Recruiting
Warsaw, Poland, 04-628
Contact: Lukasz Szumowski, Prof,    +48 22 501152728    lszumowski@ikard.pl   
Principal Investigator: Lukasz Szumowski, Prof. MD PhD         
Sponsors and Collaborators
Institute of Cardiology, Warsaw, Poland
Investigators
Study Chair: Lukasz J Szumowski, MD, PhD Institute of Cardiology, Warsaw, Poland
  More Information

No publications provided

Responsible Party: Prof Lukasz Szumowski, Institute of Cardiology, Warsaw Poland
ClinicalTrials.gov Identifier: NCT01265758     History of Changes
Other Study ID Numbers: UDAPOIG.01.03.01-00-068/09-00A
Study First Received: December 21, 2010
Last Updated: February 18, 2013
Health Authority: Poland: Ethics Committee

Keywords provided by Institute of Cardiology, Warsaw, Poland:
Atrial fibrillation
Cardiac arrhythmia
ECG
Telemonitoring
Telemetry
Holter

Additional relevant MeSH terms:
Arrhythmias, Cardiac
Atrial Fibrillation
Heart Diseases
Cardiovascular Diseases
Pathologic Processes

ClinicalTrials.gov processed this record on August 28, 2014