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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02204267
Acronym
MonDAFIS
Enrollment
3470
Registered
2014-07-30
Start date
2014-12-31
Completion date
2020-10-31
Last updated
2020-11-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Atrial Fibrillation, Stroke

Keywords

Stroke, atrial fibrillation, ECG

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.

Interventions

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)

DEVICEECG

Sponsors

Bayer Healthcare Pharmaceuticals, Inc./Bayer Schering Pharma
CollaboratorINDUSTRY
Charite University, Berlin, Germany
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Number of patients on oral anticoagulation (NOAC or VKA)12 monthsNumber 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

MeasureTime frameDescription
Number of stroke patients with newly detected atrial fibrillation7 daysNumber of stroke patients with newly detected atrial fibrillation using a standardized prolonged ECG monitoring compared to usual stroke unit diagnostic procedures alone.

Other

MeasureTime frameDescription
Impact of stroke unit level on the rate of atrial fibrillation detection7 daysImpact 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 stroke24 monthsNumber 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.

Countries

Germany

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 15, 2026