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Completed

NCT Number: NCT02204267

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

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.

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Key information

Conditions

Stroke Arrhythmias, Cardiac Atrial Fibrillation Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Heart Diseases Nervous System Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Charité Universitaetsmedizin Berlin

Berlin, 12203, Germany

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

prolonged ECG monitoring

Other

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)

ECG

Device

Primary outcomes

  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 outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

Charite University, Berlin, Germany

Other

Collaborators

  • Bayer Healthcare Pharmaceuticals, Inc./Bayer Schering Pharma

Registry information

Acronym: MonDAFIS

Important dates

Study start
2014
Primary completion
2020
Study completion
2020
First posted
Jul 30, 2014
Registry last updated
Nov 13, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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