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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified February 2006 by Cardionet.
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by:
Cardionet
ClinicalTrials.gov Identifier:
NCT00295204
First received: February 21, 2006
Last updated: August 2, 2006
Last verified: February 2006
  Purpose

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
Syncope
Pre-Syncope
Palpitations

Study Type: Observational
Study Design: Allocation: Random Sample
Time Perspective: Cross-Sectional
Official Title: Evaluation of a Mobile Cardiac Outpatient Telemetry System (CardioNet) Versus Standard Loop Event Monitor: A Multi-Center Randomized Study

Resource links provided by NLM:


Further study details as provided by Cardionet:

Estimated Enrollment: 300
Study Start Date: April 2005
Estimated Study Completion Date: October 2006
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00295204

Locations
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
Cardionet
Investigators
Principal Investigator: Stephen Rothman, MD Mainline Arrhythmia and Cardiology Associates
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00295204     History of Changes
Other Study ID Numbers: 05-002
Study First Received: February 21, 2006
Last Updated: August 2, 2006
Health Authority: United States: Institutional Review Board

Keywords provided by Cardionet:
Syncope
pre-syncope
palpitations

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

ClinicalTrials.gov processed this record on November 19, 2014