Telemetric Arrhythmia Diagnosis in Adults (TELEMARC1)

February 18, 2013 updated by: Institute of Cardiology, Warsaw, Poland

OPTIMIZING DIAGNOSTICS AND THERAPY OF ARRHYTHMIA AND SYNCOPE EVENTS USING INTELLIGENT TELEMETRIC SOLUTIONS - Evaluation of Arrhythmia Diagnostics in Adults

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

360

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Poland
      • Gdansk, Poland, 80-210
        • Recruiting
        • The Medical University of Gdańsk
        • Contact:
        • Principal Investigator:
          • Janusz Siebert, Prof. MD PhD
      • Warsaw, Poland, 04-628
        • Recruiting
        • Institute of Cardiology
        • Principal Investigator:
          • Lukasz Szumowski, Prof. MD PhD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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 Names:
  • 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 Names:
  • Medicalgorithmics, PocketECG

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Recording of symptomatic or life threatening arrhythmia event
Time Frame: 14 days
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.
14 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Quality of Life questionnaire and European Heart Rhythm Association (EHRA) scale assessment against evidence of cardiac arrhythmia occurrence.
Time Frame: 14 days
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.
14 days
Silent (asymptomatic) arrhythmia events incidence detection assessment
Time Frame: 14 days

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
14 days
Evaluation of stroke and bleeding risk factors incidence
Time Frame: 14 days
Evaluation of stroke and bleeding risk factors incidence based on scores proposed in the European Society of Cardiology (ESC) guidelines: CHADS2VASC2 and HAS-BLED.
14 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Institute of Cardiology, Warsaw, Poland

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2011

Primary Completion (Anticipated)

March 1, 2014

Study Completion (Anticipated)

March 1, 2014

Study Registration Dates

First Submitted

December 21, 2010

First Submitted That Met QC Criteria

December 22, 2010

First Posted (Estimate)

December 23, 2010

Study Record Updates

Last Update Posted (Estimate)

February 20, 2013

Last Update Submitted That Met QC Criteria

February 18, 2013

Last Verified

February 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • UDAPOIG.01.03.01-00-068/09-00A

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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