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PhysioGlove Versus Clinic Electrocardiogram Comparison (CommwellPG)

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified July 2011 by Meir Medical Center.
Recruitment status was:  Not yet recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT01407250
First Posted: August 2, 2011
Last Update Posted: August 2, 2011
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.
Information provided by:
Meir Medical Center
  Purpose
Comparison of the quality of the outpatient clinic electrocardiogram performed on patients sent to a cardiology consultation with a standard cable and the PhysioGlove-ES electrocardiograms performed in the cardiology clinic.

Condition
Patients With Normal ECG Patients With Pathological ECG

Study Type: Observational
Study Design: Time Perspective: Prospective
Official Title: Reliability of Outpatient Electrocardiogram Recordings in Patients Refered for a Cardiology Consultation

Further study details as provided by Meir Medical Center:

Primary Outcome Measures:
  • Comparison of the technical and diagnostic quality of outpatient clinic electrocardiogram with the on-site (cardiology consultation clinic) performed electrocardiograms [ Time Frame: Each patient will be tested once while visiting the cardiology consultation clinic. No further patient follow-up is planed. Data collection and evaluation is estimated at 6-9 months from study initiation ]
    The cardiology clinic electrocardiogram will be compared to the out-patient electrocardiogram brought by the patient to the cardiology consultant


Estimated Enrollment: 100
Study Start Date: August 2011
Estimated Study Completion Date: March 2012
Estimated Primary Completion Date: November 2011 (Final data collection date for primary outcome measure)
Detailed Description:

The correct performance of a 12 lead electrocardiogram depends on the correct placement of the electrocardiogram electrodes in internationally agreed upon anatomic locations on the patient's limbs and chest. This process requires specific training and diligence on the part of the electrocardiogram performer. The literature points towards a progressive quality degradation of the electrocardiogram performance probably due to the delegation of it's performance to lesser trained individuals. This study is attempting to ascertain the quality of the electrocardiogram recordings performed in non-specialized out patient clinics.

For this purpose we will compare outpatient electrocardiograms of patients referred to a cardiological consultation with electrocardiogram's acquired using a conventional electrocardiogram cable as well as the PhysioGlove-ES by the well training cardiology clinic personnel.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 95 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Adult male and female patients
Criteria

Inclusion Criteria: all consenting male and female patients age 18-95 -

Exclusion Criteria:

  1. All patients using shirt-sizes under small mand over extra-large
  2. all patients with severe chest malformations or open wounds or contagious skin infections involving the chest and/or arms -
  Contacts and Locations
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 ClinicalTrials.gov identifier (NCT number): NCT01407250


Contacts
Contact: Rasem Ganem, MD 972-05-24789880 shrasemga@clalit.org.il
Contact: Daniel David, MD 973-54-8161400 dandav@netvision.net.il

Locations
Israel
Clalit- Cardiology consult clinic Not yet recruiting
Natanya, Israel
Contact: Rasem Ganem, MD    972-52-4789880    shrasemga@clalit.org.il   
Sponsors and Collaborators
Meir Medical Center
  More Information

Responsible Party: Daniel David MD, Commwellmedica Ltd. Israel
ClinicalTrials.gov Identifier: NCT01407250     History of Changes
Other Study ID Numbers: Commwell PG 101
First Submitted: July 24, 2011
First Posted: August 2, 2011
Last Update Posted: August 2, 2011
Last Verified: July 2011