PhysioGlove Versus Clinic Electrocardiogram Comparison

Patients With Normal ECG Clinical Trial

— CommwellPG  

Official title:

Reliability of Outpatient Electrocardiogram Recordings in Patients Refered for a Cardiology Consultation

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT01407250
• Other study ID #: Commwell PG 101
• Status: Not yet recruiting
• Phase: N/A
• First received: July 24, 2011
• Last updated: July 31, 2011
• Start date: August 2011
• Est. completion date: March 2012

Study information

• Verified date: July 2011
• Source: Meir Medical Center
• Contact: Rasem Ganem, MD
• Phone: 972-05-24789880
• Email: shrasemga[@]clalit.org.il
• Is FDA regulated: No
• Health authority: Israel: Ministry of Health
• Study type: Observational

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 100
• Est. completion date: March 2012
• Est. primary completion date: November 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 95 Years

Eligibility

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 -

Study Design

Time Perspective: Prospective

Related Conditions & MeSH terms

• Patients With Normal ECG
• Patients With Pathological ECG

Locations

Country	Name	City	State
Israel	Clalit- Cardiology consult clinic	Natanya

Sponsors (1)

Lead Sponsor	Collaborator
Meir Medical Center

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Comparison of the technical and diagnostic quality of outpatient clinic electrocardiogram with the on-site (cardiology consultation clinic) performed electrocardiograms	The cardiology clinic electrocardiogram will be compared to the out-patient electrocardiogram brought by the patient to the cardiology consultant	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	No