Ignite Creation Date:
2025-12-25 @ 12:36 AM
Ignite Modification Date:
2026-03-05 @ 2:11 PM
Study NCT ID:
NCT02383667
Status:
COMPLETED
Last Update Posted:
2019-10-07
First Post:
2015-03-03
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Clinical Comparison of Electrocardiograms Collected Using an Ambulatory Holter
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'Saima.Karim@utoledo.edu', 'phone': '419-383-3697', 'title': 'Saima Karim, DO', 'organization': 'The University of Toledo'}, 'certainAgreement': {'piSponsorEmployee': True}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': 'Patients With Electrocardiograms', 'description': 'Any patient within the hospital either for procedure or for admission will be screened. Patients will be simultaneously be hooked up to two ambulatory Holter monitors for the period of time to be not less than one hour.\n\nOne holter will use standard electrodes in a standard electrode distribution. The second holter will use dry electrodes in a derived; data will be collected for 1-6 hours. After the data is collected the Holters will be removed and the data will be downloaded into the reading software to be scanned.\n\nElectrocardiogram holter', 'otherNumAtRisk': 20, 'deathsNumAtRisk': 20, 'otherNumAffected': 0, 'seriousNumAtRisk': 20, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Arrythmia', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Patients With Electrocardiograms', 'description': 'Any patient within the hospital either for procedure or for admission will be screened. Patients will be simultaneously be hooked up to two ambulatory Holter monitors for the period of time to be not less than one hour.\n\nOne holter will use standard electrodes in a standard electrode distribution. The second holter will use dry electrodes in a derived; data will be collected for 1-6 hours. After the data is collected the Holters will be removed and the data will be downloaded into the reading software to be scanned.\n\nElectrocardiogram holter'}], 'classes': [{'title': 'harness', 'categories': [{'measurements': [{'value': '4.6', 'spread': '2.30332', 'groupId': 'OG000'}]}]}, {'title': 'holter', 'categories': [{'measurements': [{'value': '7.95', 'spread': '1.877715', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': '15 minutes', 'description': 'quality of data obtained between harness and holter.\n\nSubjective evaluation:\n\n-Quality of the data will be rated on a 0 - 10 scale with 0 being unreadable and 10 being excellent', 'unitOfMeasure': 'Quality rating', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'there were 13 females and 7 males, mean age of 74.65'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Patients With Electrocardiograms', 'description': 'Any patient within the hospital either for procedure or for admission will be screened. Patients will be simultaneously be hooked up to two ambulatory Holter monitors for the period of time to be not less than one hour.\n\nOne holter will use standard electrodes in a standard electrode distribution. The second holter will use dry electrodes in a derived; data will be collected for 1-6 hours. After the data is collected the Holters will be removed and the data will be downloaded into the reading software to be scanned.\n\nElectrocardiogram holter'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '20'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '20'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}]}]}], 'recruitmentDetails': 'recruitment was done in the hospital setting with patients that were admitted. start of enrollment was 3/26/2013-3/9/15.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Patients With Electrocardiograms', 'description': 'Any patient within the hospital either for procedure or for admission will be screened. Patients will be simultaneously be hooked up to two ambulatory Holter monitors for the period of time to be not less than one hour.\n\nOne holter will use standard electrodes in a standard electrode distribution. The second holter will use dry electrodes in a derived; data will be collected for 1-6 hours. After the data is collected the Holters will be removed and the data will be downloaded into the reading software to be scanned.\n\nElectrocardiogram holter'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '4', 'groupId': 'BG000'}]}, {'title': '>=65 years', 'measurements': [{'value': '16', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '74.6', 'groupId': 'BG000', 'lowerLimit': '40', 'upperLimit': '88'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'FULL_RANGE'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '13', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '7', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '20', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 20}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-09', 'completionDateStruct': {'date': '2015-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-09-16', 'studyFirstSubmitDate': '2015-03-03', 'resultsFirstSubmitDate': '2017-11-22', 'studyFirstSubmitQcDate': '2015-03-03', 'lastUpdatePostDateStruct': {'date': '2019-10-07', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2019-09-16', 'studyFirstPostDateStruct': {'date': '2015-03-09', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2019-10-07', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2015-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Arrythmia', 'timeFrame': '15 minutes', 'description': 'quality of data obtained between harness and holter.\n\nSubjective evaluation:\n\n-Quality of the data will be rated on a 0 - 10 scale with 0 being unreadable and 10 being excellent'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Electrocardiography']}, 'descriptionModule': {'briefSummary': 'The objective of the study is to compare electrocardiograms using ambulatory holter monitor with dry electrodes in a harness versus using an ambulatory holter with standard sticky electrodes (Red Dot) on monitored patients within the hospital. Patients will be simultaneously be hooked up to two ambulatory Holter monitors for the period of time to be not less than one hour. One holter will use standard electrodes in a standard electrode distribution. The second holter will use dry electrodes in a derived.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'All patients within the hospital either for a procedure or for admission', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Any patient within the hospital either for procedure or for admission\n\nExclusion Criteria:\n\n* Patients who cannot wear a Holter monitor\n* Patients undergoing an MRI or have other contraindications for wearing an ambulatory Holter monitor.'}, 'identificationModule': {'nctId': 'NCT02383667', 'acronym': 'Orbital', 'briefTitle': 'Clinical Comparison of Electrocardiograms Collected Using an Ambulatory Holter', 'organization': {'class': 'OTHER', 'fullName': 'University of Toledo'}, 'orgStudyIdInfo': {'id': 'Orbital'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Patients with Electrocardiograms', 'description': 'Any patient within the hospital either for procedure or for admission will be screened. Patients will be simultaneously be hooked up to two ambulatory Holter monitors for the period of time to be not less than one hour.\n\nOne holter will use standard electrodes in a standard electrode distribution. The second holter will use dry electrodes in a derived; data will be collected for 1-6 hours. After the data is collected the Holters will be removed and the data will be downloaded into the reading software to be scanned.', 'interventionNames': ['Device: Electrocardiogram holter']}], 'interventions': [{'name': 'Electrocardiogram holter', 'type': 'DEVICE', 'armGroupLabels': ['Patients with Electrocardiograms']}]}, 'contactsLocationsModule': {'locations': [{'zip': '43606', 'city': 'Toledo', 'state': 'Ohio', 'country': 'United States', 'facility': 'University of Toledo, Health Science Campus', 'geoPoint': {'lat': 41.66394, 'lon': -83.55521}}], 'overallOfficials': [{'name': 'Jennifer Cummings, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'The University of Toledo'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Toledo Health Science Campus', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}