Evaluation of a Mobile Cardiac Outpatient Telemetry System Versus Standard Loop Event Monitor

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00295204
Recruitment Status : Unknown
Verified February 2006 by Cardionet.
Recruitment status was:  Active, not recruiting
First Posted : February 23, 2006
Last Update Posted : August 3, 2006
Information provided by:

Brief Summary:
Comparing the arrhythmia diagnostic yield of MCOT as compared to standard loop event monitors in patients presenting with palpitations, syncope or near syncope occurring less frequently than every 24 hours. Patients randomized and are enrolled for 30 days. Prior testing required: 24 hours of non diagnostic monitoring,

Condition or disease
Syncope Pre-Syncope Palpitations

Detailed Description:
Cardiac monitoring is used for diagnosing patient with symptoms. Holter monitoring or cardiac loop monitoring are the tests most ofter prescribed for patients depending on the frequency of symptoms. If the symptoms occur daily, a Holter may be prescribed, but when the symptoms become less frequent the diagnostic yield of Holter monitoring declines greatly. The current yields are approximately 5-10% depending on the indication. When the Holter is not longer an option for patients with infrequent symptoms a cardiac loop event monitor is prescribed to make a diagnosis. The yields on this monitoring also average approximately 25-35%. We feel that the yield on the Mobile Cardiac Ouptatient Telemetry (MCOT) service proviced by CardioNet is significantly higher due to the fact that every beat is analyzed using an algorithm and that many times the arrhythmia causing the symptoms has ended before the patient is able to press the button on the loop monitor to record the ECG. This study compares the MCOT service with Patients over 18 years of age experiencing syncope, near syncope or palpitations less frequently than daily. Require 24 hours of non-diagnostic ECG monitoring prior to randomization. Patients remain on monitoring for 30 days unless an arrhythmia diagnosis is made. The primary endpoint is confirmation of exclusion of a probable arrhythmic cause of pre-syncope, syncope or palpitations experienced by the subject prior to enrollment in the study. Secondary endpoints include time to diagnosis, time to detection of clinically significant arrhythmias, comparison of non-clinicaly significant arrhythmias, rate of asymptomatic arrhythmias both clinically and non clinically significant and a diagnosis related resource utilization. The study size is 300 subjects.

Study Type : Observational
Enrollment : 300 participants
Allocation: Random Sample
Time Perspective: Cross-Sectional
Time Perspective: Retrospective/Prospective
Official Title: Evaluation of a Mobile Cardiac Outpatient Telemetry System (CardioNet) Versus Standard Loop Event Monitor: A Multi-Center Randomized Study
Study Start Date : April 2005
Study Completion Date : October 2006

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MedlinePlus related topics: Fainting

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • syncope, pre-syncope or palpitations less frequently than every 24 hours Pre-syncope without loss of consciousness defined as transient dizziness, leghtheadedness, unsteadiness or weak spells: syncopal events with or without warning: palpitations Subjects with non-diagnostic 24 hours of monitoring related to symptoms within 45 days of enrollment into study Subject able to understand, assent to , and willing to sign the Informed Consent Form.

Exclusion Criteria:

  • Class IV heart failure Post Myocardial infarction less than or equal to 3 months Unstable angina defined as chest pain at rest, new onset of angina, or a change in existing patterns of angina.

Subjects who are candidatees for or have had recent (less than or equal to 3 monthr) heart valve surgery History of sustained ventricualr tachycardia or ventricular fibrillation documented EF 35% or less with complex ectopy defined as PVC's 10 or greater per hour.

Subject is less than 18 years old at the time of signing informed consent. Any condition which may prohibit the completion of or compliance with the protocol.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00295204

United States, New Jersey
Medicor Cardiology, PA
Bridgewater, New Jersey, United States, 08807
Garden State Cardiovascular Associates
Elizabeth, New Jersey, United States, 07202
Monmouth Cardiology Associates, LLC
Ocean, New Jersey, United States, 07712
United States, New York
Cardiovascular Associates of NY
Flushing, New York, United States, 11355
United States, Pennsylvania
Abington Medical Specialists
Abington, Pennsylvania, United States, 19001
Central Bucks Cardiology
Doylestown, Pennsylvania, United States, 18901
Central Bucks Specialitsts, LTD
Doylestown, Pennsylvania, United States, 18901
PA Heart and Vascular Group
Jenkintown, Pennsylvania, United States, 19046
Lancaster Heart and Stroke Foundation
Lancaster, Pennsylvania, United States, 17603
Southwestern PA Cardiology Associates
Pittsburgh, Pennsylvania, United States, 15219
Pottstown Medical Specialistsq
Pottstown, Pennsylvania, United States, 19464
Cardiology Consultants of Phladelphia
Yardley, Pennsylvania, United States, 19067
United States, Virginia
Virginia Cardiovascular Specialist
Richmond, Virginia, United States, 23226
Sponsors and Collaborators
Principal Investigator: Stephen Rothman, MD Mainline Arrhythmia and Cardiology Associates Identifier: NCT00295204     History of Changes
Other Study ID Numbers: 05-002
First Posted: February 23, 2006    Key Record Dates
Last Update Posted: August 3, 2006
Last Verified: February 2006

Keywords provided by Cardionet:

Additional relevant MeSH terms:
Consciousness Disorders
Neurobehavioral Manifestations
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms