PhysioGlove Versus Clinic Electrocardiogram Comparison (CommwellPG)

The recruitment status of this study is unknown because the information has not been verified recently.
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

July 24, 2011
July 31, 2011
August 2011
November 2011   (final data collection date for primary outcome measure)
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
Same as current
Complete list of historical versions of study NCT01407250 on ClinicalTrials.gov Archive Site
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PhysioGlove Versus Clinic Electrocardiogram Comparison
Reliability of Outpatient Electrocardiogram Recordings in Patients Refered for a Cardiology Consultation

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.

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.

Observational
Time Perspective: Prospective
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Probability Sample

Adult male and female patients

  • Patients With Normal ECG
  • Patients With Pathological ECG
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Not yet recruiting
100
March 2012
November 2011   (final data collection date for primary outcome measure)

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 -
Both
18 Years to 95 Years
No
Contact: Rasem Ganem, MD 972-05-24789880 shrasemga@clalit.org.il
Contact: Daniel David, MD 973-54-8161400 dandav@netvision.net.il
Israel
 
NCT01407250
Commwell PG 101
No
Daniel David MD, Commwellmedica Ltd. Israel
Meir Medical Center
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Meir Medical Center
July 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP