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

Sponsor

Charite University, Berlin, Germany (Other)

Overall Status

Completed

CT.gov ID

NCT02204267

Collaborator

Bayer Healthcare Pharmaceuticals, Inc./Bayer Schering Pharma (Industry)

3,470

Enrollment

Location

Arms

Actual Duration (Months)

49.6

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Stroke Atrial Fibrillation	Other: prolonged ECG monitoring Device: ECG	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

3470 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Diagnostic

Official Title:

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

Actual Study Start Date :

Dec 1, 2014

Actual Primary Completion Date :

May 1, 2020

Actual Study Completion Date :

Oct 1, 2020

Arms and Interventions

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

Arm

Intervention/Treatment

Experimental: prolonged ECG monitoring

Regular stroke unit treatment and diagnostic procedures according to guidelines and additional prolonged ECG monitoring

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

No Intervention: no additional ECG recording

Regular stroke unit treatment and diagnostic procedures according to guidelines

Outcome Measures

Primary Outcome Measures

Number of patients on oral anticoagulation (NOAC or VKA) [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 Outcome Measures

Number of stroke patients with newly detected atrial fibrillation [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 Outcome Measures

Impact of stroke unit level on the rate of atrial fibrillation detection [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
Number of recurrent strokes, major bleeds, myocardial infarction and all-cause death (composite endpoint) within 6, 12 and 24 months after the index stroke [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts 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