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

November 11, 2020 updated by: Matthias Endres, Charite University, Berlin, Germany
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

3470

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Berlin, Germany, 12203
        • Charité Universitaetsmedizin Berlin

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: prolonged ECG monitoring
Regular stroke unit treatment and diagnostic procedures according to guidelines and additional prolonged ECG monitoring
Device: ECG
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)
No Intervention: no additional ECG recording
Regular stroke unit treatment and diagnostic procedures according to guidelines

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
12 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
7 days

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
7 days
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.
24 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Charite University, Berlin, Germany

Collaborators

Bayer Healthcare Pharmaceuticals, Inc./Bayer Schering Pharma

Investigators

  • Principal Investigator: Matthias Endres, MD, Center for Stroke Research Berlin, Charité University Berlin, Campus Mitte

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 1, 2014

Primary Completion (Actual)

May 1, 2020

Study Completion (Actual)

October 1, 2020

Study Registration Dates

First Submitted

July 29, 2014

First Submitted That Met QC Criteria

July 29, 2014

First Posted (Estimate)

July 30, 2014

Study Record Updates

Last Update Posted (Actual)

November 13, 2020

Last Update Submitted That Met QC Criteria

November 11, 2020

Last Verified

November 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MonDAFIS
  • EA2/033/14 (Ethics comission, Charité)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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