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Impact of Standardized MONitoring for Detection of Atrial Fibrillation in Ischemic Stroke (MonDAFIS)

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ClinicalTrials.gov Identifier: NCT02204267
Recruitment Status : Active, not recruiting
First Posted : July 30, 2014
Last Update Posted : July 24, 2018
Sponsor:
Collaborator:
Bayer Healthcare Pharmaceuticals, Inc./Bayer Schering Pharma
Information provided by (Responsible Party):
Matthias Endres, Charite University, Berlin, Germany

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.

Condition or disease Intervention/treatment Phase
Stroke Atrial Fibrillation Other: prolonged ECG monitoring Device: ECG Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 3470 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Impact of Standardized MONitoring for Detection of Atrial Fibrillation in Ischemic Stroke
Study Start Date : December 2014
Estimated Primary Completion Date : December 2018
Estimated Study Completion Date : December 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: prolonged ECG monitoring
Regular stroke unit treatment and diagnostic procedures according to guidelines and additional prolonged ECG monitoring
Other: 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)

Device: ECG
No Intervention: no additional ECG recording
Regular stroke unit treatment and diagnostic procedures according to guidelines



Primary Outcome Measures :
  1. Number of patients on oral anticoagulation (NOAC or VKA) [ Time Frame: 12 months ]
    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.


Secondary Outcome Measures :
  1. Number of stroke patients with newly detected atrial fibrillation [ Time Frame: 7 days ]
    Number of stroke patients with newly detected atrial fibrillation using a standardized prolonged ECG monitoring compared to usual stroke unit diagnostic procedures alone.


Other Outcome Measures:
  1. Impact of stroke unit level on the rate of atrial fibrillation detection [ Time Frame: 7 days ]
    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

  2. Number of recurrent strokes, major bleeds, myocardial infarction and all-cause death (composite endpoint) within 6, 12 and 24 months after the index stroke [ Time Frame: 24 months ]
    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.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02204267


Locations
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Germany
Charité Universitaetsmedizin Berlin
Berlin, Germany, 12203
Sponsors and Collaborators
Charite University, Berlin, Germany
Bayer Healthcare Pharmaceuticals, Inc./Bayer Schering Pharma
Investigators
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Principal Investigator: Matthias Endres, MD Center for Stroke Research Berlin, Charité University Berlin, Campus Mitte

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Matthias Endres, Prof. Dr. med., Charite University, Berlin, Germany
ClinicalTrials.gov Identifier: NCT02204267     History of Changes
Other Study ID Numbers: MonDAFIS
EA2/033/14 ( Other Identifier: Ethics comission, Charité )
First Posted: July 30, 2014    Key Record Dates
Last Update Posted: July 24, 2018
Last Verified: July 2018

Keywords provided by Matthias Endres, Charite University, Berlin, Germany:
Stroke
atrial fibrillation
ECG

Additional relevant MeSH terms:
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Stroke
Atrial Fibrillation
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Arrhythmias, Cardiac
Heart Diseases
Pathologic Processes