Impact of Standardized MONitoring for Detection of Atrial Fibrillation in Ischemic Stroke
NCT ID: NCT02204267
Last Updated: 2020-11-13
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
3470 participants
INTERVENTIONAL
2014-12-31
2020-10-31
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
DIAGNOSTIC
NONE
Study Groups
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prolonged ECG monitoring
Regular stroke unit treatment and diagnostic procedures according to guidelines and additional prolonged ECG monitoring
prolonged ECG monitoring
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)
ECG
no additional ECG recording
Regular stroke unit treatment and diagnostic procedures according to guidelines
No interventions assigned to this group
Interventions
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prolonged ECG monitoring
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)
ECG
Eligibility Criteria
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Inclusion Criteria
* Age ≥ 18 years
* Written or oral informed consent
* Stroke unit admission within 72 hours after stroke onset
* Start of standardized prolonged ECG monitoring within 24 hours after admission to the stroke unit
* Willingness to take part in the planned follow up examinations
Exclusion Criteria
* Atrial fibrillation detected by ECG on admission
* Atrial fibrillation detected prior study enrollment on the stroke unit
* Life expectancy \< 1 year (before actual stroke)
* Life expectancy \< 1 month (after actual stroke)
* Indication for oral anticoagulation other than atrial fibrillation (e.g. mechanical heart valve)
* Severity level according National Institute of Health Stroke Scale (NIHSS) score \> 22
* Participation in an interventional trial
18 Years
ALL
No
Sponsors
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Charite University, Berlin, Germany
OTHER
Bayer Healthcare Pharmaceuticals, Inc./Bayer Schering Pharma
INDUSTRY
Responsible Party
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Matthias Endres
Prof. Dr. med.
Principal Investigators
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Matthias Endres, MD
Role: PRINCIPAL_INVESTIGATOR
Center for Stroke Research Berlin, Charité University Berlin, Campus Mitte
Locations
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Charité Universitaetsmedizin Berlin
Berlin, , Germany
Countries
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References
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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.
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.
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.
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.
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.
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.
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.
Other Identifiers
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EA2/033/14
Identifier Type: OTHER
Identifier Source: secondary_id
MonDAFIS
Identifier Type: -
Identifier Source: org_study_id