MedDataX Logo

Optimizing Diagnostics Of Syncope Events Using Intelligent Telemetric Solutions.

NCT ID: NCT01265290

Last Updated: 2011-12-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

640 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-02-28

Study Completion Date

2013-01-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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

See the medical conditions and disease areas that this research is targeting or investigating.

Cardiac Arrhythmia Cardiogenic Syncope

Keywords

Explore important study keywords that can help with search, categorization, and topic discovery.

Cardiac arrhythmia Cardiogenic syncope Pediatrics Children

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Telemetric ECG monitoring

Telemetric Full Disclosure ECG monitoring

Group Type EXPERIMENTAL

Telemetric ECG monitoring

Intervention Type DEVICE

Telemetric ECG full disclosure monitoring with GSM technology

24 hours standard Holter monitoring

Group Type EXPERIMENTAL

repeated 24 hours ECG Holter monitoring

Intervention Type DEVICE

repeated 24 hours ECG Holter monitoring

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

repeated 24 hours ECG Holter monitoring

repeated 24 hours ECG Holter monitoring

Intervention Type DEVICE

Telemetric ECG monitoring

Telemetric ECG full disclosure monitoring with GSM technology

Intervention Type DEVICE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Maximum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

National Institute of Cardiology, Warsaw, Poland

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Institute of Cardiology, Warsaw

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Lukasz Szumowski, Prof. MD PhD

Role: STUDY_CHAIR

National Institute of Cardiology, Warsaw, Poland

Katarzyna Bieganowska, Prof. MD PhD

Role: PRINCIPAL_INVESTIGATOR

Children's Memorial Health Institute

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Medical University of Warsaw Department of Pediatric Cardiology and General Pediatrics

Warsaw, , Poland

Site Status RECRUITING

The Children's Memmorial Health Institute

Warsaw, , Poland

Site Status RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

Poland

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Katarzyna Bieganowska, Prof. MD PhD

Role: CONTACT

Email: [email protected]

Maria Miszczak-Knecht, MD, PhD

Role: CONTACT

Email: [email protected]

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Bożena Werner, MD PhD

Role: primary

Katarzyna Bieganowska, MD PhD

Role: primary

Maria Miszczak-Knecht, MD PhD

Role: backup

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

UDAPOIG.01.03.01-00-068/09-00C

Identifier Type: -

Identifier Source: org_study_id