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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 : Completed
First Posted : July 30, 2014
Last Update Posted : November 13, 2020
Sponsor:
Collaborator:
Bayer Healthcare Pharmaceuticals, Inc./Bayer Schering Pharma
Information provided by (Responsible Party):
Matthias Endres, Charite University, Berlin, Germany

Tracking Information
First Submitted Date  ICMJE July 29, 2014
First Posted Date  ICMJE July 30, 2014
Last Update Posted Date November 13, 2020
Actual Study Start Date  ICMJE December 2014
Actual Primary Completion Date May 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 29, 2014)
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.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: July 29, 2014)
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.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures
 (submitted: July 29, 2014)
  • 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
  • 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.
Original Other Pre-specified Outcome Measures Same as current
 
Descriptive Information
Brief Title  ICMJE Impact of Standardized MONitoring for Detection of Atrial Fibrillation in Ischemic Stroke
Official Title  ICMJE Impact of Standardized MONitoring for Detection of Atrial Fibrillation in Ischemic Stroke
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Condition  ICMJE
  • Stroke
  • Atrial Fibrillation
Intervention  ICMJE
  • 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
Study Arms  ICMJE
  • Experimental: prolonged ECG monitoring
    Regular stroke unit treatment and diagnostic procedures according to guidelines and additional prolonged ECG monitoring
    Interventions:
    • Other: prolonged ECG monitoring
    • Device: ECG
  • No Intervention: no additional ECG recording
    Regular stroke unit treatment and diagnostic procedures according to guidelines
Publications * Haeusler KG, Kirchhof P, Heuschmann PU, Laufs U, Busse O, Kunze C, Thomalla G, Nabavi DG, Röther 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: July 29, 2014)
3470
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE October 2020
Actual Primary Completion Date May 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Germany
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02204267
Other Study ID Numbers  ICMJE MonDAFIS
EA2/033/14 ( Other Identifier: Ethics comission, Charité )
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Matthias Endres, Charite University, Berlin, Germany
Study Sponsor  ICMJE Charite University, Berlin, Germany
Collaborators  ICMJE Bayer Healthcare Pharmaceuticals, Inc./Bayer Schering Pharma
Investigators  ICMJE
Principal Investigator: Matthias Endres, MD Center for Stroke Research Berlin, Charité University Berlin, Campus Mitte
PRS Account Charite University, Berlin, Germany
Verification Date November 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP