Ignite Creation Date:
2025-12-24 @ 10:33 PM
Ignite Modification Date:
2026-04-11 @ 5:14 PM
Study NCT ID:
NCT01855035
Status:
COMPLETED
Last Update Posted:
2020-05-04
First Post:
2013-05-07
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Finding Atrial Fibrillation in Stroke - Evaluation of Enhanced and Prolonged Holter Monitoring
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D020521', 'term': 'Stroke'}, {'id': 'D000083242', 'term': 'Ischemic Stroke'}, {'id': 'D001281', 'term': 'Atrial Fibrillation'}], 'ancestors': [{'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'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D001145', 'term': 'Arrhythmias, Cardiac'}, {'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D059039', 'term': 'Standard of Care'}], 'ancestors': [{'id': 'D019984', 'term': 'Quality Indicators, Health Care'}, {'id': 'D011787', 'term': 'Quality of Health Care'}, {'id': 'D006298', 'term': 'Health Services Administration'}, {'id': 'D017530', 'term': 'Health Care Quality, Access, and Evaluation'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2014-07-10', 'size': 817443, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2020-04-30T05:03', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 402}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-04', 'completionDateStruct': {'date': '2017-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-04-30', 'studyFirstSubmitDate': '2013-05-07', 'studyFirstSubmitQcDate': '2013-05-15', 'lastUpdatePostDateStruct': {'date': '2020-05-04', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2013-05-16', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2017-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'number of atrial fibrillation/flutter', 'timeFrame': '30 month after study start', 'description': 'The primary endpoint is the detection of newly diagnosed atrial fibrillation/flutter within 6 months and before occurrence of recurrent stroke or systemic embolism in the treatment group compared to control group.'}], 'secondaryOutcomes': [{'measure': "number of atrial fibrillation (/flutter) within 12 months after patient's inclusion", 'timeFrame': '24 months after study start', 'description': "Detection of newly diagnosed atrial fibrillation (/flutter) as defined for the primary endpoint but within 12 months after patient's inclusion. As patients are recruited for 12 months, this outcome measure is determined 24 months after study start."}, {'measure': 'number of atrial fibrillation (/flutter) without hospitalisation', 'timeFrame': '30 months after study start', 'description': 'Detection of newly diagnosed atrial fibrillation (/flutter) as defined for the primary endpoint with the exception that hospitalisation for atrial fibrillation (/flutter) will be considered as censoring.'}, {'measure': 'number of recurrent stroke or systemic embolism', 'timeFrame': '24 months after study start', 'description': "Recurrent stroke or systemic embolism within 12 months after patient's inclusion. As patients are recruited for 12 months, this outcome measure is determined 24 months after study start."}, {'measure': 'total mortality', 'timeFrame': '24 months after study start', 'description': "Total death within 12 months after patient's inclusion. As patients are recruited for 12 months, this outcome measure is determined 24 months after study start."}, {'measure': 'number of cardiovascular deaths', 'timeFrame': '24 months after study start'}, {'measure': 'number of cerebrovascular deaths', 'timeFrame': '24 months after study start'}, {'measure': 'number of transient ischemic attacks', 'timeFrame': '24 months after study start'}, {'measure': 'number of myocardial infarctions', 'timeFrame': '24 months after study start'}, {'measure': 'number of bleeding complications', 'timeFrame': '24 months after study start'}, {'measure': 'quality of life', 'timeFrame': '24 months after study start'}, {'measure': 'number of atrial fibrillation (/flutter) in extended monitoring period', 'timeFrame': '24 months after study start', 'description': 'Incremental detection of atrial fibrillation (/flutter) in the extended Holter monitoring periods after 3 and 6 months.'}, {'measure': 'costs', 'timeFrame': '24 months after study start'}, {'measure': 'number of correct monitorings', 'timeFrame': '24 months after study start', 'description': 'To assess the feasibility of monitoring procedures.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['ischemic stroke', 'ECG monitoring', 'atrial fibrillation (/flutter)'], 'conditions': ['Stroke']}, 'referencesModule': {'references': [{'pmid': '28187920', 'type': 'BACKGROUND', 'citation': 'Wachter R, Groschel K, Gelbrich G, Hamann GF, Kermer P, Liman J, Seegers J, Wasser K, Schulte A, Jurries F, Messerschmid A, Behnke N, Groschel S, Uphaus T, Grings A, Ibis T, Klimpe S, Wagner-Heck M, Arnold M, Protsenko E, Heuschmann PU, Conen D, Weber-Kruger M; Find-AF(randomised) Investigators and Coordinators. Holter-electrocardiogram-monitoring in patients with acute ischaemic stroke (Find-AFRANDOMISED): an open-label randomised controlled trial. Lancet Neurol. 2017 Apr;16(4):282-290. doi: 10.1016/S1474-4422(17)30002-9. Epub 2017 Feb 8.'}, {'pmid': '25262252', 'type': 'BACKGROUND', 'citation': 'Weber-Kruger M, Gelbrich G, Stahrenberg R, Liman J, Kermer P, Hamann GF, Seegers J, Groschel K, Wachter R; Find-AF(RANDOMISED) investigators. Finding atrial fibrillation in stroke patients: Randomized evaluation of enhanced and prolonged Holter monitoring--Find-AF(RANDOMISED) --rationale and design. Am Heart J. 2014 Oct;168(4):438-445.e1. doi: 10.1016/j.ahj.2014.06.018. Epub 2014 Jul 3.'}, {'pmid': '33421630', 'type': 'DERIVED', 'citation': 'Sadlonova M, Wasser K, Nagel J, Weber-Kruger M, Groschel S, Uphaus T, Liman J, Hamann GF, Kermer P, Groschel K, Herrmann-Lingen C, Wachter R. Health-related quality of life, anxiety and depression up to 12 months post-stroke: Influence of sex, age, stroke severity and atrial fibrillation - A longitudinal subanalysis of the Find-AFRANDOMISED trial. J Psychosom Res. 2021 Mar;142:110353. doi: 10.1016/j.jpsychores.2020.110353. Epub 2021 Jan 2.'}, {'pmid': '31813354', 'type': 'DERIVED', 'citation': 'Wasser K, Weber-Kruger M, Groschel S, Uphaus T, Liman J, Hamann GF, Kermer P, Seegers J, Binder L, Gelbrich G, Groschel K, Wachter R. Brain Natriuretic Peptide and Discovery of Atrial Fibrillation After Stroke: A Subanalysis of the Find-AFRANDOMISED Trial. Stroke. 2020 Feb;51(2):395-401. doi: 10.1161/STROKEAHA.119.026496. Epub 2019 Dec 9.'}, {'pmid': '31071137', 'type': 'DERIVED', 'citation': 'Wasser K, Weber-Kruger M, Jurries F, Liman J, Hamann GF, Kermer P, Uphaus T, Protsenko E, Seegers J, Mende M, Groschel K, Wachter R. The cardiac diagnostic work-up in stroke patients-A subanalysis of the Find-AFRANDOMISED trial. PLoS One. 2019 May 9;14(5):e0216530. doi: 10.1371/journal.pone.0216530. eCollection 2019.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to assess whether repeated enhanced and prolonged ECG monitoring after ischemic stroke results in a higher detection of atrial fibrillation (/flutter) compared to usual care (at least 24 hour of cardiac monitoring).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '60 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Recent cerebral ischemia defined as stroke (sudden focal neurologic deficit lasting \\> 24h consistent with the territory of a major cerebral artery and categorised as ischemic) and/or a corresponding lesion on brain imaging.\n* Stroke symptoms started ≤ 7 days ago.\n* Age ≥ 60 years.\n* Modified Rankin scale ≤ 2 (prior to index event).\n\nExclusion Criteria:\n\n* Known history of atrial fibrillation/flutter or atrial fibrillation/flutter on admission ECG.\n* Indication for oral anticoagulation at randomisation.\n* Absolute contra-indication against oral anticoagulation at randomisation.\n* Intracerebral bleeding in medical history.\n* Patient scheduled for Holter-ECG or cardiac Event-Recording monitoring ≥ 48 hours.\n* Significant carotid artery or vertebral artery stenosis \\> 50% (NASCET classification), significant intracranial artery stenosis suspicious of atherosclerotic origin or acute arterial dissection explanatory of stroke symptoms.\n* Implanted pacemaker device or cardioverter/defibrillator.\n* Life expectancy \\< 1 year for reasons other than stroke (e.g. metastatic cancer).\n* Concomitant participation in other controlled randomised trial.'}, 'identificationModule': {'nctId': 'NCT01855035', 'briefTitle': 'Finding Atrial Fibrillation in Stroke - Evaluation of Enhanced and Prolonged Holter Monitoring', 'organization': {'class': 'OTHER', 'fullName': 'Institut fuer anwendungsorientierte Forschung und klinische Studien GmbH'}, 'officialTitle': 'A Prospective, Randomised, Controlled Study to Determine the Detection of Atrial Fibrillation by Prolonged and Enhanced Holter Monitoring as Compared to Usual Care in Stroke Patients', 'orgStudyIdInfo': {'id': 'Find-AF randomised'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'prolonged ECG monitoring', 'description': 'Prolonged ECG monitoring: 10-day Holter ECG at months 0, 3 and 6', 'interventionNames': ['Other: prolonged ECG monitoring']}, {'type': 'OTHER', 'label': 'standard care', 'description': 'Usual care according to current guidelines (minimum of 24 hours of cardiac monitoring).', 'interventionNames': ['Other: standard care']}], 'interventions': [{'name': 'prolonged ECG monitoring', 'type': 'OTHER', 'description': '10-day Holter ECG measurement', 'armGroupLabels': ['prolonged ECG monitoring']}, {'name': 'standard care', 'type': 'OTHER', 'description': 'Usual care according to current guidelines (minimum of 24 hours of cardiac monitoring).', 'armGroupLabels': ['standard care']}]}, 'contactsLocationsModule': {'locations': [{'zip': '37075', 'city': 'Göttingen', 'country': 'Germany', 'facility': 'Dept. of Cardiology and Pneumology, University Medical Center Goettingen', 'geoPoint': {'lat': 51.53443, 'lon': 9.93228}}, {'zip': '55131', 'city': 'Mainz', 'country': 'Germany', 'facility': 'Clinic and Policlinic for Neurology, University of Mainz', 'geoPoint': {'lat': 49.98185, 'lon': 8.28008}}, {'zip': '26452', 'city': 'Sande', 'country': 'Germany', 'facility': 'Dept. of Neurology, Nordwest-Hospital Sanderbusch', 'geoPoint': {'lat': 53.50489, 'lon': 8.01418}}, {'zip': '65199', 'city': 'Wiesbaden', 'country': 'Germany', 'facility': 'Dept. of Neurology, HSK, Dr. Horst-Schmidt-Hospital', 'geoPoint': {'lat': 50.08601, 'lon': 8.24435}}], 'overallOfficials': [{'name': 'Rolf Wachter, PD Dr. med.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Dept. of Cardiology and Pneumology, University Medical Center Goettingen'}, {'name': 'Klaus Gröschel, PD Dr.med.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Clinic and Policlinic for Neurology, University of Mainz'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Institut fuer anwendungsorientierte Forschung und klinische Studien GmbH', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}