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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:
Information provided by:
Meir Medical Center
ClinicalTrials.gov Identifier:
NCT01407250
First received: July 24, 2011
Last updated: July 31, 2011
Last verified: July 2011
  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 ] [ Designated as safety issue: No ]
    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

Ages Eligible for Study:   18 Years to 95 Years   (Adult, Senior)
Genders Eligible for Study:   Both
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
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: NCT01407250

Locations
Israel
Clalit- Cardiology consult clinic
Natanya, Israel
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 
Study First Received: July 24, 2011
Last Updated: July 31, 2011
Health Authority: Israel: Ministry of Health

ClinicalTrials.gov processed this record on December 02, 2016