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

Charité University Medicine Berlin logo

Charité University Medicine Berlin

Status

Completed

Conditions

Atrial Fibrillation
Stroke

Treatments

Device: ECG
Other: prolonged ECG monitoring

Study type

Interventional

Funder types

Other
Industry

Identifiers

NCT02204267
MonDAFIS
EA2/033/14

Details and patient eligibility

About

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.

Enrollment

3,470 patients

Sex

All

Ages

18+ years old

Volunteers

No 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

Trial design

Primary purpose

Diagnostic

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

3,470 participants in 2 patient groups

prolonged ECG monitoring
Experimental group
Description:
Regular stroke unit treatment and diagnostic procedures according to guidelines and additional prolonged ECG monitoring
Treatment:
Device: ECG
Other: prolonged ECG monitoring
no additional ECG recording
No Intervention group
Description:
Regular stroke unit treatment and diagnostic procedures according to guidelines

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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