Cardiac ArrhythmiaTELEMARC3NCT01265290
Optimizing Diagnostics Of Syncope Events Using Intelligent Telemetric Solutions.
A study testing repeated 24 hours ECG Holter monitoring and Telemetric ECG monitoring in people with Cardiac Arrhythmia and Cardiogenic Syncope, 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 to diagnose syncope in comparison with standard diagnostic procedure Read more about this study
- Who is it for?
- Ages Up to 18 years
- Conditions the study is for
- Cardiac Arrhythmia, Cardiogenic Syncope
- What is being tested?
- repeated 24 hours ECG Holter monitoring and Telemetric ECG monitoring
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 640 participants
- Where
- 2 sitesPoland
- Study dates
- Feb 2011to Jan 2013
- 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 Up to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- History of syncope
- Ability to operate the telemetric device at home
Who cannot join
- informed consent undersigned by the parents
- informed consent undersigned by the child if over 16 years of age
- 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
Trial locations and contacts
2 sites in 1 country.
Katarzyna Bieganowska, Prof. MD PhD contact
Maria Miszczak-Knecht, MD, PhD contact
Poland2 sites, 2 recruiting
- Recruiting
Medical University of Warsaw Department of Pediatric Cardiology and General Pediatrics
Warsaw, 00-576
Bożena Werner, MD PhD, (+48 22) 629 83 17, kardiologia@litewska.edu.pl
Bożena Werner, MD PhD
- Recruiting
The Children's Memmorial Health Institute
Warsaw, 04-730
Katarzyna Bieganowska, MD PhD, kbieganowska@wp.pl
Maria Miszczak-Knecht, MD PhD, mmknecht@neostrada.pl
About this study
Official title: Optimizing Diagnostics And Therapy Of Arrhythmia And Syncope Events Using Intelligent Telemetric Solutions. Diagnostics Of Syncope In Children.
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
Read the 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.
- Conditions
- Cardiac Arrhythmia, Cardiogenic Syncope
- Being tested
- repeated 24 hours ECG Holter monitoring, Telemetric ECG monitoring
- Keywords
- Cardiac arrhythmia, Cardiogenic syncope, Pediatrics, Children
- Medical subject headings
- Arrhythmias, Cardiac, Syncope
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
repeated 24 hours ECG Holter monitoringDevice
repeated 24 hours ECG Holter monitoring
Telemetric ECG monitoringDevice
Telemetric ECG full disclosure monitoring with GSM technology
| Study group | Role | What they receive |
|---|---|---|
| Telemetric ECG monitoring | Experimental | Telemetric Full Disclosure ECG monitoring Receives: Device: Telemetric ECG monitoring |
| 24 hours standard Holter monitoring | Experimental | Not described Receives: Device: repeated 24 hours ECG Holter monitoring |
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 30 days. Patients in the control group will have standard ECG Holter monitoring repeated twice
Measured: within 30 days since the start of monitoring
Secondary outcomes (2)
Occurrence of silent (asymptomatic) arrhythmia event
Measured: within 30 days since the start of monitoring
1. Verification of patient self assessment based on the Quality of Life questionnaire and EHRA scale against evidence of cardiac arrhythmia occurrence
Measured: within 30 days since the start of monitoring
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 completionDec 2012 (estimated)
- Study completionJan 2013 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiac ArrhythmiaStudies 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
- 640 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Institute of Cardiology, Warsaw, Poland
- Sponsor type
- University, hospital or other
- Investigators
- Lukasz Szumowski, Prof. MD PhD, Study chair, National Institute of Cardiology, Warsaw, PolandKatarzyna Bieganowska, Prof. MD PhD, Principal investigator, Children's Memorial Health Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01265290
- Sponsor's protocol ID
- UDAPOIG.01.03.01-00-068/09-00C
- Acronym
- TELEMARC3
- Status last verified
- Dec 2011
- First submitted
- 22 Dec 2010
- Last updated
- 5 Dec 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Dec 2011. 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. Diagnostics Of Syncope In Children.
- ClinicalTrials.gov ID
- NCT01265290
- Acronym / sponsor ID
- TELEMARC3 / UDAPOIG.01.03.01-00-068/09-00C
- Conditions
- Cardiac Arrhythmia, Cardiogenic Syncope
- Keywords
- Cardiac arrhythmia, Cardiogenic syncope, Pediatrics, Children
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 640 participants (estimated)
- Lead sponsor
- National Institute of Cardiology, Warsaw, PolandUniversity, hospital or other
- Study start
- Feb 2011
- Primary completion
- Dec 2012 (estimated)
- Study completion
- Jan 2013 (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 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.
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: Telemetric ECG monitoringTelemetric Full Disclosure ECG monitoring |
| 24 hours standard Holter monitoring | Experimental | Device: repeated 24 hours ECG Holter monitoring |
Who may qualify
- Ages
- Up to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (2 listed)
- History of syncope
- Ability to operate the telemetric device at home
Key exclusion criteria (8 listed)
- informed consent undersigned by the parents
- informed consent undersigned by the child if over 16 years of age
- Syncope with known underlying disease
- Inability to operate the telemetric device at home
- Complete Heart block
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 |
|---|---|---|
| repeated 24 hours ECG Holter monitoringrepeated 24 hours ECG Holter monitoring | Device | 24 hours standard Holter monitoring |
| Telemetric ECG monitoringTelemetric ECG full disclosure monitoring with GSM technology | Device | Telemetric ECG monitoring |
Primary outcome
Recording of symptomatic or life threatening arrhythmia event
Time frame: within 30 days since the start of monitoring
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
2 secondary outcomes
Occurrence of silent (asymptomatic) arrhythmia event
Time frame: within 30 days since the start of monitoring
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Dec 2011.
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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.
Katarzyna Bieganowska, Prof. MD PhD contact
Maria Miszczak-Knecht, MD, PhD contact
Lukasz Szumowski, Prof. MD PhD study chair
National Institute of Cardiology, Warsaw, Poland
Katarzyna Bieganowska, Prof. MD PhD principal investigator
Children's Memorial Health Institute
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing repeated 24 hours ECG Holter monitoring and Telemetric ECG monitoring in people with Cardiac Arrhythmia and Cardiogenic Syncope, 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 2 inclusion and 8 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 5 Dec 2011. 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 Katarzyna Bieganowska, Prof. MD PhD (kbieganowska@wp.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: within 30 days since the start of monitoring). 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 5 Dec 2011.