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Sponsored by: |
Cardionet |
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Information provided by: | Cardionet |
ClinicalTrials.gov Identifier: | NCT00295204 |
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 |
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Syncope Pre-Syncope Palpitations |
Study Type: | Observational |
Study Design: | Cross-Sectional, Random Sample, Retrospective/Prospective Study |
Official Title: | Evaluation of a Mobile Cardiac Outpatient Telemetry System (CardioNet) Versus Standard Loop Event Monitor: A Multi-Center Randomized Study |
Estimated Enrollment: | 300 |
Study Start Date: | April 2005 |
Estimated Study Completion Date: | October 2006 |
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.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
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.
United States, New Jersey | |
Monmouth Cardiology Associates, LLC | |
Ocean, New Jersey, United States, 07712 | |
Garden State Cardiovascular Associates | |
Elizabeth, New Jersey, United States, 07202 | |
Medicor Cardiology, PA | |
Bridgewater, New Jersey, United States, 08807 | |
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 Specialitsts, LTD | |
Doylestown, Pennsylvania, United States, 18901 | |
Cardiology Consultants of Phladelphia | |
Yardley, Pennsylvania, United States, 19067 | |
Central Bucks Cardiology | |
Doylestown, Pennsylvania, United States, 18901 | |
PA Heart and Vascular Group | |
Jenkintown, Pennsylvania, United States, 19046 | |
Pottstown Medical Specialistsq | |
Pottstown, Pennsylvania, United States, 19464 | |
Southwestern PA Cardiology Associates | |
Pittsburgh, Pennsylvania, United States, 15219 | |
Lancaster Heart and Stroke Foundation | |
Lancaster, Pennsylvania, United States, 17603 | |
United States, Virginia | |
Virginia Cardiovascular Specialist | |
Richmond, Virginia, United States, 23226 |
Principal Investigator: | Stephen Rothman, MD | Mainline Arrhythmia and Cardiology Associates |
Study ID Numbers: | 05-002 |
Study First Received: | February 21, 2006 |
Last Updated: | August 2, 2006 |
ClinicalTrials.gov Identifier: | NCT00295204 |
Health Authority: | United States: Institutional Review Board |
Syncope pre-syncope palpitations |
Signs and Symptoms Unconsciousness Consciousness Disorders |
Neurologic Manifestations Neurobehavioral Manifestations Syncope |
Nervous System Diseases |