Ignite Creation Date:
2025-12-24 @ 5:25 PM
Ignite Modification Date:
2025-12-28 @ 9:33 PM
Study NCT ID:
NCT01407250
Status:
UNKNOWN
Last Update Posted:
2011-08-02
First Post:
2011-07-24
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
PhysioGlove Versus Clinic Electrocardiogram Comparison
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 100}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2011-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2011-07', 'completionDateStruct': {'date': '2012-03', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2011-07-31', 'studyFirstSubmitDate': '2011-07-24', 'studyFirstSubmitQcDate': '2011-07-31', 'lastUpdatePostDateStruct': {'date': '2011-08-02', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2011-08-02', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-11', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Comparison of the technical and diagnostic quality of outpatient clinic electrocardiogram with the on-site (cardiology consultation clinic) performed electrocardiograms', 'timeFrame': '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', 'description': 'The cardiology clinic electrocardiogram will be compared to the out-patient electrocardiogram brought by the patient to the cardiology consultant'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Patients With Normal ECG', 'Patients With Pathological ECG']}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': "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.\n\nFor 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."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '95 Years', 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Adult male and female patients', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria: all consenting male and female patients age 18-95 -\n\nExclusion Criteria:\n\n1. All patients using shirt-sizes under small mand over extra-large\n2. all patients with severe chest malformations or open wounds or contagious skin infections involving the chest and/or arms -'}, 'identificationModule': {'nctId': 'NCT01407250', 'acronym': 'CommwellPG', 'briefTitle': 'PhysioGlove Versus Clinic Electrocardiogram Comparison', 'organization': {'class': 'OTHER', 'fullName': 'Meir Medical Center'}, 'officialTitle': 'Reliability of Outpatient Electrocardiogram Recordings in Patients Refered for a Cardiology Consultation', 'orgStudyIdInfo': {'id': 'Commwell PG 101'}}, 'contactsLocationsModule': {'locations': [{'city': 'Netanya', 'country': 'Israel', 'contacts': [{'name': 'Rasem Ganem, MD', 'role': 'CONTACT', 'email': 'shrasemga@clalit.org.il', 'phone': '972-52-4789880'}], 'facility': 'Clalit- Cardiology consult clinic', 'geoPoint': {'lat': 32.33291, 'lon': 34.85992}}], 'centralContacts': [{'name': 'Rasem Ganem, MD', 'role': 'CONTACT', 'email': 'shrasemga@clalit.org.il', 'phone': '972-05-24789880'}, {'name': 'Daniel David, MD', 'role': 'CONTACT', 'email': 'dandav@netvision.net.il', 'phone': '973-54-8161400'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Meir Medical Center', 'class': 'OTHER'}, 'responsibleParty': {'oldNameTitle': 'Daniel David MD', 'oldOrganization': 'Commwellmedica Ltd. Israel'}}}}