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

Stroke Clinical Trial

— MonDAFIS  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02204267
• Other study ID #: MonDAFIS
• Secondary ID: EA2/033/14
• Status: Completed
• Phase: N/A
• Start date: December 2014
• Est. completion date: October 2020

Study information

• Verified date: November 2020
• Source: Charite University, Berlin, Germany
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 3470
• Est. completion date: October 2020
• Est. primary completion date: May 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Atrial Fibrillation
• Stroke

Intervention

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)

Device:
• ECG

Locations

Country	Name	City	State
Germany	Charité Universitaetsmedizin Berlin	Berlin

Sponsors (2)

Lead Sponsor	Collaborator
Charite University, Berlin, Germany	Bayer Healthcare Pharmaceuticals, Inc./Bayer Schering Pharma

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Impact of stroke unit level on the rate of atrial fibrillation detection	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
Other	Number of recurrent strokes, major bleeds, myocardial infarction and all-cause death (composite endpoint) within 6, 12 and 24 months after the index stroke	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
Primary	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.	12 months
Secondary	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.	7 days