Ignite Creation Date:
2025-12-24 @ 4:05 PM
Ignite Modification Date:
2026-01-04 @ 4:41 PM
Study NCT ID:
NCT02261766
Status:
COMPLETED
Last Update Posted:
2015-06-24
First Post:
2014-10-01
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Evaluation of 5 Days Holter and 30 Days Thumb-ECG for Detection of Atrial Fibrillation in Stroke Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001281', 'term': 'Atrial Fibrillation'}, {'id': 'D020521', 'term': 'Stroke'}], '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'}, {'id': 'D002561', 'term': 'Cerebrovascular Disorders'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D015716', 'term': 'Electrocardiography, Ambulatory'}], 'ancestors': [{'id': 'D004562', 'term': 'Electrocardiography'}, {'id': 'D006334', 'term': 'Heart Function Tests'}, {'id': 'D003935', 'term': 'Diagnostic Techniques, Cardiovascular'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}, {'id': 'D004568', 'term': 'Electrodiagnosis'}, {'id': 'D018670', 'term': 'Monitoring, Ambulatory'}, {'id': 'D008991', 'term': 'Monitoring, Physiologic'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 100}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-06', 'completionDateStruct': {'date': '2015-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-06-23', 'studyFirstSubmitDate': '2014-10-01', 'studyFirstSubmitQcDate': '2014-10-07', 'lastUpdatePostDateStruct': {'date': '2015-06-24', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2014-10-10', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Atrial fibrillation detection rate on Thumb-ECG', 'timeFrame': '1 month'}], 'secondaryOutcomes': [{'measure': 'Atrial fibrillation detection rate on holtermonitoring', 'timeFrame': '5 days'}, {'measure': 'Time to detection of atrial fibrillation on holter', 'timeFrame': '5 days'}, {'measure': 'Time to detection af atrial fibrillation on thumb-ECG', 'timeFrame': '30 days'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Atrial Fibrillation', 'Stroke']}, 'referencesModule': {'references': [{'pmid': '27694312', 'type': 'DERIVED', 'citation': 'Poulsen MB, Binici Z, Dominguez H, Soja AM, Kruuse C, Hornnes AH, Rasmussen RS, Overgaard K. Performance of short ECG recordings twice daily to detect paroxysmal atrial fibrillation in stroke and transient ischemic attack patients. Int J Stroke. 2017 Feb;12(2):192-196. doi: 10.1177/1747493016669883. Epub 2016 Sep 30.'}]}, 'descriptionModule': {'briefSummary': 'This study will compare the two methods 5 days holtermonitoring and 30 days thumb electrocardiogram for detection of atrial fibrillation in stroke patients', 'detailedDescription': 'Patients with a newly stroke will be examined with both 5 day holter monitoring and 30 days thumb ECG at the same time. The detection rates of the two methods will be compared'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['OLDER_ADULT'], 'minimumAge': '65 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* stroke or TIA within the last 3 months verified by a CT or a MR scan or unequivocal symptoms and old infarcts visualised on CT or MR\n* age 65 or above\n* patients able to handle the thumb-ECG\n* written informed consent\n\nExclusion Criteria:\n\n* earlier diagnose of atrial fibrillation\n* pacemaker or ICD device\n* stroke induced by trauma, infection or surgery procedure\n* carotid stenosis of more than 60%'}, 'identificationModule': {'nctId': 'NCT02261766', 'acronym': 'EHOT', 'briefTitle': 'Evaluation of 5 Days Holter and 30 Days Thumb-ECG for Detection of Atrial Fibrillation in Stroke Patients', 'organization': {'class': 'OTHER', 'fullName': 'Herlev Hospital'}, 'officialTitle': 'Detection of Atrial Fibrillation, -Evaluation of 5 Days Holter and 30 Days Thumb-ECG for Detection of Atrial Fibrillation in Stroke Patients', 'orgStudyIdInfo': {'id': 'EHOT001'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Holter monitoring and Thumb ECG', 'type': 'DEVICE', 'description': '5 days holtermonitoring and 30 days 30 seconds twice daily thumb ECG recording'}]}, 'contactsLocationsModule': {'locations': [{'zip': '2730', 'city': 'Herlev', 'country': 'Denmark', 'facility': 'Department of Neurology, Herlev Hospital', 'geoPoint': {'lat': 55.72366, 'lon': 12.43998}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Herlev Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Medical Doctor', 'investigatorFullName': 'Karsten Overgaard', 'investigatorAffiliation': 'Herlev Hospital'}}}}