Impact of standardized MONitoring for Detection of Atrial Fibrillation in Ischemic Stroke (MonDAFIS): Rationale and design of a prospective randomized multicenter study - 06/02/16
, Paulus Kirchhof, MD c, d, e, Peter U. Heuschmann, MD f, Ulrich Laufs, MD g, Otto Busse, MD b, Claudia Kunze, BA a, Götz Thomalla, MD h, Darius G. Nabavi, MD b, i, Joachim Röther, MD b, j, Roland Veltkamp, MD b, k, Matthias Endres, MD a, b, l, m, nRésumé |
Background |
Atrial fibrillation (AF) is estimated to account for approximately every fifth ischemic stroke. In routine clinical practice, detection of undiagnosed, clinically silent AF represents a major diagnostic challenge, and in up to 30% of patients with ischemic stroke, AF remains undetected. The MonDAFIS study has been designed to quantify the diagnostic yield and clinical relevance of systematic electrocardiogram (ECG) monitoring for patients with acute ischemic stroke during the subsequent in hospital stay.
Study Design |
A prospective randomized multicenter study in 3,470 patients with acute ischemic stroke or transient ischemic attack and without known AF on hospital admission. Over a period of approximately 2years, patients will be enrolled in about 30 German-certified stroke units and randomized 1:1 to receive either usual stroke unit diagnostic procedures for detection of AF (control group) or usual stroke unit diagnostic procedures plus standardized and centrally analyzed Holter ECG recording for up to 7days in hospital (intervention group). Results of the ECG core laboratory analysis will be provided to the patients and treating physicians. All patients will be followed up for treatment and cardiovascular outcomes at 6, 12, and 24months after enrollment.
Outcomes |
The primary outcome of the randomized MonDAFIS study is the proportion of patients who receive anticoagulation therapy 12months after the index stroke. Secondary outcomes include the number of stroke patients with newly detected AF in hospital and the rate of recurrent stroke, major bleedings, myocardial infarction, or death 6, 12, and 24months after the index event. MonDAFIS will also explore patient-reported adherence to anticoagulants, the clinical relevance of short atrial tachycardia, or excessive supraventricular ectopic activity as well as cost-effectiveness of prolonged, centrally analyzed ECG recordings.
Conclusion |
MonDAFIS will be the largest study to date to evaluate whether a prolonged and systematic ECG monitoring during the initial in hospital stay has an impact on secondary stroke prevention. In addition, prognosis as well as adherence to medication up to 2 years after the index stroke will be analyzed. The primary results of the MonDAFIS study may have the potential to change the current guidelines recommendations regarding ECG workup after ischemic stroke.
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| Conflict of interest: K.G.H. reports speaker's honoraria, consulting fees, lecture honoraria, and study grants from Bayer Healthcare, Sanofi, Pfizer, and Bristol-Myers Squibb. A full list of conflicts of interest for P.K. is available on the homepage of the European Society of Cardiology (www.escardio.org). P.U.H. reports grants from Charité–Universitätsmedizin Berlin during study conduct (within MonDAFIS for biometry; member scientific board; MonDAFIS is supported by an unrestricted research grant to the Charité from Bayer); grants from BMBF, EU, Charité, Berlin Chamber of Physicians, German Parkinson Society, University Hospital Würzburg, Robert-Koch-Institute, University Göttingen (within FIND-AF randomized for stroke adjudication; member stroke adjucation committee; Find-AFRANDOMIZED is supported by an unrestricted research grant to the University Göttingen from Boehringer-Ingelheim), and University Hospital Heidelberg (within RASUNOA-prime for biometry and data management; member steering committee; RASUNOA-prime is supported by an unrestricted research grant to the University Hospital Heidelberg from Bayer, BMS, Boehringer-Ingelheim), outside submitted work. U.L. reports honoraria/reimbursements for lectures, participation in studies, scientific cooperations (with Saarland University), consulting, travel, support (of colleagues), or support of scientific meetings (within the last 5years) by ABDA, AkdÄ, Amgen, AstraZeneca, Bayer, Berlin-Chemie, Boehringer-Ingelheim, DACH, Daiichi-Sankyo, DFG, EU, i-cor, Lilly, Medtronik, MSD, Pfizer, Roche, Sanofi, Servier, Stifterverbad, Synlab, UdS, and UKS. O.B. and C.B. report no conflicts of interest. G.T. has received speaker's honoraria and consulting fees from Acandis, Bayer Healthcare, Boehringer Ingelheim, Covidien, Bristol-Myers-Squibb, and Pfizer. D.G.N. has received speaker's honoraria and consulting fees from Bayer, Boehringer Ingelheim, Bristol-Myers-Squibb, Daiichi Sankyo, Novartis, and Pfizer. J.R. has received speaker's honoraria and consulting fees from Bayer, Boehringer Ingelheim, Bristol-Myers-Squibb, Pfizer, and Astra Zeneca. R.V. has received speaker's honoraria, consulting fees, and research support from Bayer, Boehringer Ingelheim, Bristol-Myers-Squibb, Daiichi Sankyo, Apoplex Medical Technologies, Morphosys, Biogen, and Pfizer. M.E. reports lecture fees and study grants by Bayer, Boehringer Ingelheim, Bristol-Myers-Squibb, Ever, Glaxo Smith Kline, MSD, Novartis, and Pfizer. |
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| Trial registration: Clinicaltrials.gov NCT02204267. |
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| Grants: This study is supported by a grant from Bayer Vital GmbH, Bayer HealthCare Pharmaceuticals, Germany. |
Vol 172
P. 19-25 - février 2016 Retour au numéro
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