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

Primary Purpose

Stroke, Atrial Fibrillation

Status
Completed
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
prolonged ECG monitoring
ECG
Sponsored by
Charite University, Berlin, Germany
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Stroke focused on measuring Stroke, atrial fibrillation, ECG

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Charité Universitaetsmedizin Berlin

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

prolonged ECG monitoring

no additional ECG recording

Arm Description

Regular stroke unit treatment and diagnostic procedures according to guidelines and additional prolonged ECG monitoring

Regular stroke unit treatment and diagnostic procedures according to guidelines

Outcomes

Primary Outcome Measures

Number of patients on oral anticoagulation (NOAC or VKA)
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

Number of stroke patients with newly detected atrial fibrillation
Number of stroke patients with newly detected atrial fibrillation using a standardized prolonged ECG monitoring compared to usual stroke unit diagnostic procedures alone.

Full Information

First Posted
July 29, 2014
Last Updated
November 11, 2020
Sponsor
Charite University, Berlin, Germany
Collaborators
Bayer Healthcare Pharmaceuticals, Inc./Bayer Schering Pharma
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1. Study Identification

Unique Protocol Identification Number
NCT02204267
Brief Title
Impact of Standardized MONitoring for Detection of Atrial Fibrillation in Ischemic Stroke
Acronym
MonDAFIS
Official Title
Impact of Standardized MONitoring for Detection of Atrial Fibrillation in Ischemic Stroke
Study Type
Interventional

2. Study Status

Record Verification Date
November 2020
Overall Recruitment Status
Completed
Study Start Date
December 2014 (Actual)
Primary Completion Date
May 2020 (Actual)
Study Completion Date
October 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Charite University, Berlin, Germany
Collaborators
Bayer Healthcare Pharmaceuticals, Inc./Bayer Schering Pharma

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stroke, Atrial Fibrillation
Keywords
Stroke, atrial fibrillation, ECG

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
3470 (Actual)

8. Arms, Groups, and Interventions

Arm Title
prolonged ECG monitoring
Arm Type
Experimental
Arm Description
Regular stroke unit treatment and diagnostic procedures according to guidelines and additional prolonged ECG monitoring
Arm Title
no additional ECG recording
Arm Type
No Intervention
Arm Description
Regular stroke unit treatment and diagnostic procedures according to guidelines
Intervention Type
Other
Intervention Name(s)
prolonged ECG monitoring
Intervention Description
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)
Intervention Type
Device
Intervention Name(s)
ECG
Primary Outcome Measure Information:
Title
Number of patients on oral anticoagulation (NOAC or VKA)
Description
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.
Time Frame
12 months
Secondary Outcome Measure Information:
Title
Number of stroke patients with newly detected atrial fibrillation
Description
Number of stroke patients with newly detected atrial fibrillation using a standardized prolonged ECG monitoring compared to usual stroke unit diagnostic procedures alone.
Time Frame
7 days
Other Pre-specified Outcome Measures:
Title
Impact of stroke unit level on the rate of atrial fibrillation detection
Description
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
Time Frame
7 days
Title
Number of recurrent strokes, major bleeds, myocardial infarction and all-cause death (composite endpoint) within 6, 12 and 24 months after the index stroke
Description
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.
Time Frame
24 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Matthias Endres, MD
Organizational Affiliation
Center for Stroke Research Berlin, Charité University Berlin, Campus Mitte
Official's Role
Principal Investigator
Facility Information:
Facility Name
Charité Universitaetsmedizin Berlin
City
Berlin
ZIP/Postal Code
12203
Country
Germany

12. IPD Sharing Statement

Citations:
PubMed Identifier
34022169
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.
Results Reference
derived
PubMed Identifier
26856211
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.
Results Reference
derived

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Impact of Standardized MONitoring for Detection of Atrial Fibrillation in Ischemic Stroke

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