Ignite Creation Date:
2025-12-25 @ 12:34 AM
Ignite Modification Date:
2026-01-23 @ 10:55 AM
Study NCT ID:
NCT02204267
Status:
COMPLETED
Last Update Posted:
2020-11-13
First Post:
2014-07-29
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Impact of Standardized MONitoring for Detection of Atrial Fibrillation in Ischemic Stroke
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D020521', 'term': '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': 'D004562', 'term': 'Electrocardiography'}], 'ancestors': [{'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'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 3470}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-12', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-11', 'completionDateStruct': {'date': '2020-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-11-11', 'studyFirstSubmitDate': '2014-07-29', 'studyFirstSubmitQcDate': '2014-07-29', 'lastUpdatePostDateStruct': {'date': '2020-11-13', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2014-07-30', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2020-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Impact of stroke unit level on the rate of atrial fibrillation detection', 'timeFrame': '7 days', 'description': 'Impact of stroke unit level (i.e. primary or comprehensive stroke center) on the rate of atrial fibrillation detection in-hospital stroke in patients randomized to standardized prolonged ECG monitoring in hospital'}, {'measure': 'Number of recurrent strokes, major bleeds, myocardial infarction and all-cause death (composite endpoint) within 6, 12 and 24 months after the index stroke', 'timeFrame': '24 months', 'description': 'Number of recurrent strokes, major bleeds, myocardial infarction and all-cause death (composite endpoint) within 6, 12 and 24 months after the index stroke in patients either randomized to standardized prolonged ECG monitoring in-hospital or those randomized to usual stroke unit diagnostic procedures alone.'}], 'primaryOutcomes': [{'measure': 'Number of patients on oral anticoagulation (NOAC or VKA)', 'timeFrame': '12 months', 'description': 'Number of study patients on oral anticoagulation (NOAC or VKA) at 12 months after the index stroke either randomized to standardized prolonged ECG monitoring in-hospital or those randomized to usual stroke unit diagnostic procedures alone.'}], 'secondaryOutcomes': [{'measure': 'Number of stroke patients with newly detected atrial fibrillation', 'timeFrame': '7 days', 'description': 'Number of stroke patients with newly detected atrial fibrillation using a standardized prolonged ECG monitoring compared to usual stroke unit diagnostic procedures alone.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Stroke', 'atrial fibrillation', 'ECG'], 'conditions': ['Stroke', 'Atrial Fibrillation']}, 'referencesModule': {'references': [{'pmid': '39791425', 'type': 'DERIVED', 'citation': 'Haeusler KG, Tutuncu S, Fiessler C, Jawad-Ul-Qamar M, Kunze C, Schurig J, Dietzel J, Kramer M, Petzold GC, Royl G, Helberg T, Thomalla G, Nabavi DG, Rother J, Laufs U, Veltkamp R, Heuschmann PU, Kirchhof P, Olma MC, Endres M. Excessive Supraventricular Ectopic Activity in Patients With Acute Ischemic Stroke Is Associated With Atrial Fibrillation Detection Within 24 Months After Stroke: A Predefined Analysis of the MonDAFIS Study. J Am Heart Assoc. 2025 Jan 21;14(2):e034512. doi: 10.1161/JAHA.123.034512. Epub 2025 Jan 10.'}, {'pmid': '38619714', 'type': 'DERIVED', 'citation': 'Tutuncu S, Olma MC, Kunze C, Dietzel J, Schurig J, Rosenkranz M, Stingele R, Maschke M, Heuschmann PU, Kirchhof P, Laufs U, Nabavi DG, Rother J, Thomalla G, Veltkamp R, Endres M, Haeusler KG; MonDAFIS Investigators. Heart failure, recurrent vascular events and death in patients with ischemic stroke-results of the MonDAFIS study. Intern Emerg Med. 2024 Aug;19(5):1247-1254. doi: 10.1007/s11739-024-03594-8. Epub 2024 Apr 15.'}, {'pmid': '37794453', 'type': 'DERIVED', 'citation': 'Ingwersen T, Olma MC, Schlemm E, Mayer C, Cheng B, Tutuncu S, Kirchhof P, Veltkamp R, Rother J, Laufs U, Nabavi DG, Ntaios G, Endres M, Haeusler KG, Thomalla G. Independent external validation of a stroke recurrence score in patients with embolic stroke of undetermined source. Neurol Res Pract. 2023 Oct 5;5(1):51. doi: 10.1186/s42466-023-00279-z.'}, {'pmid': '37259147', 'type': 'DERIVED', 'citation': 'Olma MC, Tutuncu S, Grittner U, Kunze C, Jawad-Ul-Qamar M, Kirchhof P, Rother J, Thomalla G, Veltkamp R, Laufs U, Nabavi DG, Heuschmann PU, Endres M, Haeusler KG. Extent of routine diagnostic cardiac work-up at certified German stroke units participating in the prospective MonDAFIS study. Neurol Res Pract. 2023 Jun 1;5(1):21. doi: 10.1186/s42466-023-00246-8.'}, {'pmid': '36628982', 'type': 'DERIVED', 'citation': 'Olma MC, Tutuncu S, Fiessler C, Kunze C, Kramer M, Steindorf-Sabath L, Jawad-Ul-Qamar M, Kirchhof P, Laufs U, Schurig J, Kraft P, Rother J, Gunther A, Thomalla G, Dimitrijeski B, Nabavi DG, Veltkamp R, Heuschmann PU, Haeusler KG, Endres M; MonDAFIS Investigators [Link]. In-Hospital ECG Findings, Changes in Medical Management, and Cardiovascular Outcomes in Patients With Acute Stroke or Transient Ischemic Attack. J Am Heart Assoc. 2023 Jan 17;12(2):e027149. doi: 10.1161/JAHA.122.027149. Epub 2023 Jan 11.'}, {'pmid': '34022169', 'type': 'DERIVED', 'citation': 'Haeusler KG, Kirchhof P, Kunze C, Tutuncu S, Fiessler C, Malsch C, Olma MC, Jawad-Ul-Qamar M, Kramer M, Wachter R, Michalski D, Kraft A, Rizos T, Groschel K, Thomalla G, Nabavi DG, Rother J, Laufs U, Veltkamp R, Heuschmann PU, Endres M; MonDAFIS Investigators. Systematic monitoring for detection of atrial fibrillation in patients with acute ischaemic stroke (MonDAFIS): a randomised, open-label, multicentre study. Lancet Neurol. 2021 Jun;20(6):426-436. doi: 10.1016/S1474-4422(21)00067-3.'}, {'pmid': '26856211', 'type': 'DERIVED', 'citation': 'Haeusler KG, Kirchhof P, Heuschmann PU, Laufs U, Busse O, Kunze C, Thomalla G, Nabavi DG, Rother J, Veltkamp R, Endres M. Impact of standardized MONitoring for Detection of Atrial Fibrillation in Ischemic Stroke (MonDAFIS): Rationale and design of a prospective randomized multicenter study. Am Heart J. 2016 Feb;172:19-25. doi: 10.1016/j.ahj.2015.10.010. Epub 2015 Oct 21.'}]}, 'descriptionModule': {'briefSummary': 'Investigator-initiated prospective randomized multicentre study to uncover the true burden of paroxysmal atrial fibrillation in a representative population of acute stroke patients without known atrial fibrillation.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Acute ischemic stroke or transitory ischemic attack (with clinical deficit on enrolment or MRI detected acute brain lesion on admission)\n* Age ≥ 18 years\n* Written or oral informed consent\n* Stroke unit admission within 72 hours after stroke onset\n* Start of standardized prolonged ECG monitoring within 24 hours after admission to the stroke unit\n* Willingness to take part in the planned follow up examinations\n\nExclusion Criteria:\n\n* Known atrial fibrillation\n* Atrial fibrillation detected by ECG on admission\n* Atrial fibrillation detected prior study enrollment on the stroke unit\n* Life expectancy \\< 1 year (before actual stroke)\n* Life expectancy \\< 1 month (after actual stroke)\n* Indication for oral anticoagulation other than atrial fibrillation (e.g. mechanical heart valve)\n* Severity level according National Institute of Health Stroke Scale (NIHSS) score \\> 22\n* Participation in an interventional trial'}, 'identificationModule': {'nctId': 'NCT02204267', 'acronym': 'MonDAFIS', 'briefTitle': 'Impact of Standardized MONitoring for Detection of Atrial Fibrillation in Ischemic Stroke', 'organization': {'class': 'OTHER', 'fullName': 'Charite University, Berlin, Germany'}, 'officialTitle': 'Impact of Standardized MONitoring for Detection of Atrial Fibrillation in Ischemic Stroke', 'orgStudyIdInfo': {'id': 'MonDAFIS'}, 'secondaryIdInfos': [{'id': 'EA2/033/14', 'type': 'OTHER', 'domain': 'Ethics comission, Charité'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'prolonged ECG monitoring', 'description': 'Regular stroke unit treatment and diagnostic procedures according to guidelines and additional prolonged ECG monitoring', 'interventionNames': ['Other: prolonged ECG monitoring', 'Device: ECG']}, {'type': 'NO_INTERVENTION', 'label': 'no additional ECG recording', 'description': 'Regular stroke unit treatment and diagnostic procedures according to guidelines'}], 'interventions': [{'name': 'prolonged ECG monitoring', 'type': 'OTHER', 'description': 'Start of long-term ECG immediately after admission to the stroke unit by using a portable ECG recorder for a max. duration of 7 days (or hospital discharge)', 'armGroupLabels': ['prolonged ECG monitoring']}, {'name': 'ECG', 'type': 'DEVICE', 'armGroupLabels': ['prolonged ECG monitoring']}]}, 'contactsLocationsModule': {'locations': [{'zip': '12203', 'city': 'Berlin', 'country': 'Germany', 'facility': 'Charité Universitaetsmedizin Berlin', 'geoPoint': {'lat': 52.52437, 'lon': 13.41053}}], 'overallOfficials': [{'name': 'Matthias Endres, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Center for Stroke Research Berlin, Charité University Berlin, Campus Mitte'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Charite University, Berlin, Germany', 'class': 'OTHER'}, 'collaborators': [{'name': 'Bayer Healthcare Pharmaceuticals, Inc./Bayer Schering Pharma', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Prof. Dr. med.', 'investigatorFullName': 'Matthias Endres', 'investigatorAffiliation': 'Charite University, Berlin, Germany'}}}}