Clinical trial NCT02204267: Impact of Standardized MONitoring for Detection of Atrial Fibrillation in Ischemic Stroke
Official title: Impact of Standardized MONitoring for Detection of Atrial Fibrillation in Ischemic Stroke
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Stroke
Atrial Fibrillation
Keywords: Stroke
atrial fibrillation
ECG
Lead sponsor: Charite University, Berlin, Germany
Sponsor class: OTHER
Collaborators: name: Bayer Healthcare Pharmaceuticals, Inc./Bayer Schering Pharma
First posted: 2014-07-30
Enrollment: 3470
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: 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.


Eligibility criteria: Inclusion Criteria:

* Acute ischemic stroke or transitory ischemic attack (with clinical deficit on enrolment or MRI detected acute brain lesion on admission)
* 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:

* Known atrial fibrillation
* 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

Primary outcomes:
measure: Number of patients on oral anticoagulation (NOAC or VKA)
timeFrame: 12 months
Secondary outcomes:
measure: Number of stroke patients with newly detected atrial fibrillation
timeFrame: 7 days
Other outcomes:
measure: Impact of stroke unit level on the rate of atrial fibrillation detection
timeFrame: 7 days
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
Locations:
city: Berlin
country: Germany
facility: Charité Universitaetsmedizin Berlin
Study officials:
affiliation: Center for Stroke Research Berlin, Charité University Berlin, Campus Mitte
name: Matthias Endres, MD
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.