Ignite Creation Date:
2025-12-24 @ 11:03 PM
Ignite Modification Date:
2026-02-25 @ 5:49 PM
Study NCT ID:
NCT02214069
Status:
COMPLETED
Last Update Posted:
2017-12-13
First Post:
2014-08-06
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Using Smart Phone Technology in Detecting the Presence of Atrial Fibrillation
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001281', 'term': 'Atrial Fibrillation'}, {'id': 'D001282', 'term': 'Atrial Flutter'}], 'ancestors': [{'id': 'D001145', 'term': 'Arrhythmias, Cardiac'}, {'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D011996', 'term': 'Records'}], 'ancestors': [{'id': 'D003625', 'term': 'Data Collection'}, {'id': 'D004812', 'term': 'Epidemiologic Methods'}, {'id': 'D008919', 'term': 'Investigative Techniques'}, {'id': 'D009934', 'term': 'Organization and Administration'}, {'id': 'D006298', 'term': 'Health Services Administration'}, {'id': 'D017531', 'term': 'Health Care Evaluation Mechanisms'}, {'id': 'D011787', 'term': 'Quality of Health Care'}, {'id': 'D017530', 'term': 'Health Care Quality, Access, and Evaluation'}, {'id': 'D011634', 'term': 'Public Health'}, {'id': 'D004778', 'term': 'Environment and Public Health'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 60}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-08', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-12', 'completionDateStruct': {'date': '2017-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-12-11', 'studyFirstSubmitDate': '2014-08-06', 'studyFirstSubmitQcDate': '2014-08-11', 'lastUpdatePostDateStruct': {'date': '2017-12-13', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2014-08-12', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Examine the accuracy of the AliveCor software in detecting AF or sinus rhythm compared to the physician interpretation', 'timeFrame': '6 month', 'description': 'Both the software nd overreading electrophysiologist come to the same conclusion regarding the rhythm of the ECG and Alivecor reading. Both determining that the tracing is either normal sinus rhythm or atrial fibrillation.'}], 'secondaryOutcomes': [{'measure': 'Assess the correlation between QT interval derived from the AliveCor device compared to standard 12 lead ECG, as assessed by the overreading electrophysiologists.', 'timeFrame': '6 months'}]}, 'oversightModule': {'isUsExport': True, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'conditions': ['Atrial Fibrillation', 'Atrial Flutter']}, 'referencesModule': {'references': [{'pmid': '30143448', 'type': 'DERIVED', 'citation': 'William AD, Kanbour M, Callahan T, Bhargava M, Varma N, Rickard J, Saliba W, Wolski K, Hussein A, Lindsay BD, Wazni OM, Tarakji KG. Assessing the accuracy of an automated atrial fibrillation detection algorithm using smartphone technology: The iREAD Study. Heart Rhythm. 2018 Oct;15(10):1561-1565. doi: 10.1016/j.hrthm.2018.06.037. Epub 2018 Aug 22.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to examine whether patients can use the AliveCor case to record their heart rhythm and to assess the accuracy of the software in detecting AF vs sinus rhythm', 'detailedDescription': 'AliveCor is a new monitoring technology used with a smart phone which allows patients to record their rhythm. The study will compare AliveCor recordings and automated interpretation of the rhythm with the interpretation by an Electrophysiologist.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients admitted to the hospital for your atrial fibrillation or atrial flutter', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Male or female between \\> 18 and \\< 80 years of age\n2. Paroxysmal or persistent atrial fibrillation\n3. Admitted for antiarrhythmic drug loading (Dofetilide or Sotalol)\n4. Already has iPhone 4, 4S or 5 with data plan that accommodates the AliveCor case\n5. Willing to use the Alive Cor case\n6. Written informed consent\n\nExclusion Criteria:\n\n1. Unable or unwilling to use the Alive Cor case for their smart phone\n2. Presence of a permanent pacemaker'}, 'identificationModule': {'nctId': 'NCT02214069', 'acronym': 'iRead', 'briefTitle': 'Using Smart Phone Technology in Detecting the Presence of Atrial Fibrillation', 'organization': {'class': 'OTHER', 'fullName': 'The Cleveland Clinic'}, 'officialTitle': 'Assessing the Accuracy of an Atrial Fibrillation Detection Algorithm Using Novel Smart Phone Technology in Detecting the Presence of Atrial Fibrillation. iRead Study', 'orgStudyIdInfo': {'id': '14-612'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Patients with Atrial Fibrillation', 'description': 'Patients with Atrial Fibrillation admitted to the hospital for drug loading with Dofetilide or Sotalol willing to record and transmit heart rhythm using AliveCor.', 'interventionNames': ['Device: Record and transmit heart rhythm']}], 'interventions': [{'name': 'Record and transmit heart rhythm', 'type': 'DEVICE', 'description': 'The patient uses the AliveCor device to record and transmit heart rhythm two times a day. The patient, device software, and Electrophysiologist interpret the rhythm', 'armGroupLabels': ['Patients with Atrial Fibrillation']}]}, 'contactsLocationsModule': {'locations': [{'zip': '44195', 'city': 'Cleveland', 'state': 'Ohio', 'country': 'United States', 'facility': 'Cleveland Clinic', 'geoPoint': {'lat': 41.4995, 'lon': -81.69541}}], 'overallOfficials': [{'name': 'Khaldoun Tarakji, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'The Cleveland Clinic'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'The Cleveland Clinic', 'class': 'OTHER'}, 'collaborators': [{'name': 'AliveCor', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Staff', 'investigatorFullName': 'Khaldoun Tarakji', 'investigatorAffiliation': 'The Cleveland Clinic'}}}}