Atrial FibrillationTELEMARC1NCT01265758
Telemetric Arrhythmia Diagnosis in Adults
A study testing Prolonged telemetric Full Disclosure ECG recording. in people with Atrial Fibrillation and Arrhythmia, run by National Institute of Cardiology, Warsaw, Poland at 2 sites in Poland.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Atrial Fibrillation, Arrhythmia
- What is being tested?
- Prolonged telemetric Full Disclosure ECG recording.
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 360 participants
- Where
- 2 sitesPoland
- Study dates
- Feb 2011to Mar 2014
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- Evidence of previously recorded arrhythmia
- Inability to comply with the study protocol
- Lack of patient cooperation
Trial locations and contacts
2 sites in 1 country.
Poland2 sites, 2 recruiting
- Recruiting
The Medical University of Gdańsk
Gdansk, 80-210
Janusz Siebert, Prof. MD PhD, jsiebert@amg.gda.pl
Janusz Siebert, Prof. MD PhD
- Recruiting
Institute of Cardiology
Warsaw, 04-628
Lukasz Szumowski, Prof,, +48 22 501152728, lszumowski@ikard.pl
Lukasz Szumowski, Prof. MD PhD
About this study
Official title: 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.
Read the 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.
- Conditions
- Atrial Fibrillation, Arrhythmia
- Being tested
- Prolonged telemetric Full Disclosure ECG recording.
- Keywords
- Atrial fibrillation, Cardiac arrhythmia, ECG, Telemonitoring, Telemetry, Holter
- Medical subject headings
- Atrial Fibrillation, Arrhythmias, Cardiac
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Prolonged telemetric Full Disclosure ECG recording.Device
Also called Medicalgorithmics, PocketECG
Continuous Full Disclosure Telemetric ECG monitoring lasting 14 days
| Study group | Role | What they receive |
|---|---|---|
| Telemetric ECG monitoring | Experimental | Telemetric 14-days Full Disclosure ECG recording. Receives: Device: Prolonged telemetric Full Disclosure ECG recording. |
| Standard 24-hours Holter ECG recording | Active comparator | Standard 24-hours Holter ECG recording repeated 3 times unless arrhythmia is diagnosed earlier. Receives: Device: Prolonged telemetric Full Disclosure ECG recording. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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 14 days. Patients in the control group will have standard ECG Holter monitoring repeated 3 times unless arrhythmia is diagnosed earlier.
Measured: 14 days
Secondary outcomes (3)
Quality of Life questionnaire and European Heart Rhythm Association (EHRA) scale assessment against evidence of cardiac arrhythmia occurrence.
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.
Measured: 14 days
Silent (asymptomatic) arrhythmia events incidence detection assessment
Evaluation of silent (asymptomatic) arrhythmia events incidence which potentially could cause serious complications
- Atrial fibrillation
- Atrial flutter
- Atrial Tachycardia
- Ventricular tachycardia
Measured: 14 days
Evaluation of stroke and bleeding risk factors incidence
Evaluation of stroke and bleeding risk factors incidence based on scores proposed in the European Society of Cardiology (ESC) guidelines: CHADS2VASC2 and HAS-BLED.
Measured: 14 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Dec 2010 (estimated)
- Study startFeb 2011
- Primary completionMar 2014 (estimated)
- Study completionMar 2014 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Atrial FibrillationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 360 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Institute of Cardiology, Warsaw, Poland
- Sponsor type
- University, hospital or other
- Investigators
- Lukasz J Szumowski, MD, PhD, Study chair, National Institute of Cardiology, Warsaw, Poland
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01265758
- Sponsor's protocol ID
- UDAPOIG.01.03.01-00-068/09-00A
- Acronym
- TELEMARC1
- Status last verified
- Feb 2013
- First submitted
- 21 Dec 2010
- Last updated
- 20 Feb 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Feb 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- OPTIMIZING DIAGNOSTICS AND THERAPY OF ARRHYTHMIA AND SYNCOPE EVENTS USING INTELLIGENT TELEMETRIC SOLUTIONS - Evaluation of Arrhythmia Diagnostics in Adults
- ClinicalTrials.gov ID
- NCT01265758
- Acronym / sponsor ID
- TELEMARC1 / UDAPOIG.01.03.01-00-068/09-00A
- Conditions
- Atrial Fibrillation, Arrhythmia
- Keywords
- Atrial fibrillation, Cardiac arrhythmia, ECG, Telemonitoring, Telemetry, Holter
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 360 participants (estimated)
- Lead sponsor
- National Institute of Cardiology, Warsaw, PolandUniversity, hospital or other
- Study start
- Feb 2011
- Primary completion
- Mar 2014 (estimated)
- Study completion
- Mar 2014 (estimated)
- First posted
- 23 Dec 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Telemetric ECG monitoring | Experimental | Device: Prolonged telemetric Full Disclosure ECG recording.Telemetric 14-days Full Disclosure ECG recording. |
| Standard 24-hours Holter ECG recording | Active comparator | Device: Prolonged telemetric Full Disclosure ECG recording.Standard 24-hours Holter ECG recording repeated 3 times unless arrhythmia is diagnosed earlier. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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)
Key exclusion criteria (3 listed)
- Evidence of previously recorded arrhythmia
- Inability to comply with the study protocol
- Lack of patient cooperation
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Prolonged telemetric Full Disclosure ECG recording.Also: Medicalgorithmics, PocketECGContinuous Full Disclosure Telemetric ECG monitoring lasting 14 days | Device | Standard 24-hours Holter ECG recording, Telemetric ECG monitoring |
Primary outcome
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.
3 secondary outcomes
Quality of Life questionnaire and European Heart Rhythm Association (EHRA) scale assessment against evidence of cardiac arrhythmia occurrence.
Time frame: 14 days
Silent (asymptomatic) arrhythmia events incidence detection assessment
Time frame: 14 days
Evaluation of stroke and bleeding risk factors incidence
Time frame: 14 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Feb 2013.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Lukasz J Szumowski, MD, PhD study chair
National Institute of Cardiology, Warsaw, Poland
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Prolonged telemetric Full Disclosure ECG recording. in people with Atrial Fibrillation and Arrhythmia, run by National Institute of Cardiology, Warsaw, Poland at 2 sites in Poland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 20 Feb 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Poland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Lukasz Szumowski, MD, PhD (+48501152728, lszumowski@ikard.pl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Recording of symptomatic or life threatening arrhythmia event (time frame: 14 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Feb 2013.