PhysioGlove Versus Clinic Electrocardiogram Comparison (CommwellPG)
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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 |
- 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) |
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 |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Probability Sample |
Adult male and female patients
Inclusion Criteria: all consenting male and female patients age 18-95 -
Exclusion Criteria:
- All patients using shirt-sizes under small mand over extra-large
- all patients with severe chest malformations or open wounds or contagious skin infections involving the chest and/or arms -
Contacts and Locations| Contact: Rasem Ganem, MD | 972-05-24789880 | shrasemga@clalit.org.il |
| Contact: Daniel David, MD | 973-54-8161400 | dandav@netvision.net.il |
| Israel | |
| Clalit- Cardiology consult clinic | Not yet recruiting |
| Natanya, Israel | |
| Contact: Rasem Ganem, MD 972-52-4789880 shrasemga@clalit.org.il | |
More Information
No publications provided
| 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 May 19, 2013