Prevent complications

MonDAFIS - Impact of standardized MONitoring for Detection of Atrial Fibrillation in Ischemic Stroke

Investigator-initiated, prospective, randomized, open-label, multi-center trial with two parallel groups. Randomization of patients happens 1:1 into one group that receives standard care and one group that receives standard care plus additional Holter ECG monitoring.
More information/project description

Research Group Endres
Research Group Häusler

Project Description

We are pleased to welcome you on the homepage of the „Impact of standardized MONitoring for Detection of Atrial Fibrillation in Ischemic Stroke (MonDAFIS)“ study of the Charité–Universitätsmedizin Berlin. For the duration of the research period this site will inform you about all study related matters including publications and oral presentations.

With kind regards from Berlin,
The MonDAFIS team.

Scientific background

Atrial fibrillation (AF) is the most frequent cardiac arrhythmia and the number of patients with AF will increase within the next years as the population ages. Different forms of AF (i.e. paroxysmal, persistent and permanent) confer a similar stroke risk and furthermore AF accounts for every fifth ischemic stroke in Germany. Patients with AF-related cardio-embolic strokes show a poorer prognosis and a higher recurrence rate compared to strokes of other etiologies. Long-term oral anticoagulation with vitamin K antagonists (VKAs) reduces the risk of recurrent stroke in AF patients by about two thirds compared to placebo and is substantially more effective than acetylsalicylic acid. It emerges that new oral anticoagulants (NOACs) such as dabigatran, rivaroxaban or apixaban are at least as effective or even more effective compared to the VKA warfarin for the prevention of recurrent stroke, (intracranial) bleeding and death. National and international guidelines recommend oral anticoagulation for patients with AF and prior ischemic stroke with the highest level of evidence.

The detection of paroxysmal, so far undetected (“silent”) AF represents a major diagnostic challenge in patients with acute ischemic stroke, remaining undetected in a relevant proportion of stroke patients. However, prolonged (post-hospital) ECG monitoring and systematic analysis of ECG recordings enhances detection of non-permanent AF after ischemic stroke, but optimal length of monitoring remains unclear. Moreover, implantable cardiac-event recorders increase AF detection rates in selected stroke cohorts, but are invasive and expensive, not supporting routine use. As most of the published ECG data are taken from single-center studies, current stroke guidelines do not recommend prolonged ECG monitoring and do not specify the requirements for ECG analysis in stroke survivors. Subsequently, there is no common practice or “gold standard” of ECG monitoring in most healthcare systems, as well as in the German stroke unit system. This fact likely results in an important under-diagnosis of AF in stroke survivors. A systematic assessment and randomized comparison of the diagnostic yield and therapeutic impact of prolonged ECG monitoring for silent AF in stroke survivors would have immediate impact on patient management, as oral anticoagulation would only be prescribed to optimize secondary stroke prevention after ischemic stroke or TIA when AF has been documented. Moreover, a standardized prolonged continuous ECG monitoring will help to clarify the clinical relevance of short-lasting atrial runs (<30 s and ≥ 6 conducted premature activations; so called “paroxysmal short atrial tachycardia”), a common finding in stroke patients. According to US claims data, paroxysmal short atrial tachycardia was independently associated with a twofold higher risk of subsequent stroke. In addition, the Copenhagen Holter Study demonstrated that excessive supraventricular ectopic activity was associated with an almost threefold risk of hospital admission due to AF or ischemic stroke. Nevertheless, paroxysmal short atrial tachycardia as well as excessive supraventricular ectopic activity is not defined as (paroxysmal) AF and therefore, there is no indication for the prescription of oral anticoagulants according to guidelines. Taken together, well-designed large prospective, randomized, multicenter studies are urgently needed to clarify these major issues of stroke prevention and will help to optimize the use of VKAs and NOACs. The proposed MonDAFIS study will help to define the optimal duration and modality of ECG recording after ischemic stroke or TIA and could change the diagnostic workup for stroke patients in Germany and throughout Europe.

Study design

Investigator-initiated, prospective, randomized, open-label, multi-center trial with two parallel groups. Patients are randomized 1:1 into a standard care group and  a standard care plus additional Holter ECG monitoring group, respectively. More information at https://clinicaltrials.gov/ct2/show/NCT02204267.

Scientific Board

Prof. Dr. med. M. Endres (PI) (Neurology, Charité – University Hospital Berlin)
PD Dr. med. K. G. Häusler (Center for Stroke Research Berlin)
Prof. Dr. med. P. Kirchhof (Centre for Cardiovasc Sci., Univ. Birmingham, UK)
Prof. Dr. med. U. Laufs (Cardiology, Internal medicine III, Homburg/S.)
Prof. Dr. med. P. U. Heuschmann (Institute for Clinical Epidemiology and Biometry, Julius-Maximilians University, Würzburg)
Prof. Dr. med. D. Nabavi (Neurology, Vivantes Klinikum Neukölln, Berlin)
Prof. Dr. med. J. Röther (Neurology, Asklepios Klinik Altona, Hamburg)
PD Dr. med. G. Thomalla (Neurology, University Hospital Hamburg-Eppendorf)
Prof. Dr. med. R. Veltkamp (Neurology, Queens College London, UK)

Principal Investigator of the „Impact of standardized MONitoring for Detection of Atrial Fibrillation in Ischemic Stroke (MonDAFIS)“ study is Prof. Dr. med. M. Endres. The study is conducted through the MonDAFIS study headquarters of the Center for Stroke Research Berlin (CSB) at the Charité - University Hospital and financially supported by Bayer HealthCare, Bayer Vital GmbH

Team of the study headquarters

Prof. Dr. med. Matthias Endres

Principal Investigator
Phone  +49 30 450 560 102
Fax  +49 30 450 560 932

PD Dr. med. Karl Georg Häusler

Co-Principal Investigator
georg.haeusler(at)charite.de
Phone  +49 30 450 560 663
Fax  +49 30 450 560 979

Claudia Kunze, B.A.

Project Manager
c.kunze(at)charite.de
Phone  +49 30 450 560 678
Fax +49 30 450 7 560 916

Gesa Nöhren

Monitor
gesa.noehren(at)charite.de
Phone +40 30 450 560 678
Fax +49 30 450 7 560 916

Dr. med. Joanna Dietzel

Investigating Physician
joanna.dietzel(at)charite.de
Phone +49 30 450 560 673
Fax +49 30 450 560 979

Johannes Schurig

Investigating Physician
johannes.schurig(at)charite.de
Phone +49 30 450 560 673
Fax +49 30 450 7 560 916

Dr. med. Serdar Tütüncü

Investigating Physician
serdar.tuetuencue(at)charite.de
Tel. +49 30 450 560 496
Fax +49 30 450 7 560 496

Petra Dem

Study Assistent
petra.dem(at)charite.de
Phone +49 30 450 560 687

Cardiological Corelab

Dr. Muhammad Jawad Ul-Qamar

Cardiological Corelab Birmingham

Prof. Dr. med. Paulus Kirchhof

Supervisor of the Cardiological Corelab Birmingham

Biometric core lab

Power calculation and statistical analysis will be conducted under supervision of Prof. Dr. P.U. Heuschmann at the Institute for Clinical Epidemiology and Biometry at the University of Würzburg.

Collaborating research facilities

Since initiation of the study in February 2015 until the end of August 2016, already 38 clinical Centers in the federal states Baden-Wuerttemberg, Berlin, Brandenburg, Hamburg, Lower Saxony, North Rhine-Westphalia, Saxony, Saxony- Anhalt, Schleswig-Holstein, Thuringia and Meckelnburg-Western Pomerania were included. In this regard, the Mondafis team gives thanks to all collaborating clinical study sites for the professional and sincere working climate during the initiation process.

Recruitment

Since recruitment initiation at Charite - university hospital Berlin in December 2014 and during the following months 38 additional study sites with 2229 participants were included until October 2016. The rate of recruitment was continuously increased since study initiation and we expect to hold the current inclusion rate of more than 140 participants per month. Sincere thanks to all actively recruiting study sites for their dedicating work.

 

 

Monitoring

The subject matter of monitoring is the control of adherence to the study protocol according to GCP as well as compliance with legal regularities. Furthermore monitoring ensures a high standard of data quality and consequently raises the validity of the study.

Publications

Upcoming study meetings

The next meeting for all members of the study teams will take place at 01.00 p.m. on February 17 2017 at the congress of neurointensiv care in Vienna at the Austria Center Vienna.

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