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Extended rhythm SCreening for AtRial Fibrillation in cryptogenic stroke patients

Completed
Conditions
stroke cerebrovascular accident
10007521
10007963
Registration Number
NL-OMON41263
Lead Sponsor
Medisch Spectrum Twente
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Completed
Sex
Not specified
Target Recruitment
50
Inclusion Criteria

Patients > 18 years of age
Recent episode (<=60 days) of cryptogenic ischemic stroke
Undetermined etiology with negative evaluation (including cardioembolism work-up) according to the TOAST criteria
Implantation of an implantable loop recorder within two months after index event
Able of providing informed consent

Exclusion Criteria

Pre-existing indication for vitamin K antagonist
Untreated hyperthyroidism
Indication for pacemaker implantation, ICD or CRT device
Severe co-morbidity not likely to complete follow-up for one year

Study & Design

Study Type
Observational invasive
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
<p>The percentage of patients with documented AF based on implantable cardiac<br /><br>monitor registration during a follow-up period of at least 12 months after an<br /><br>episode of cryptogenic stroke. Compared to usual care consisting of an 12 lead<br /><br>ECG upon outpatient clinic visit. An episode of AF is defined as an episode of<br /><br>at least 120 seconds duration.</p><br>
Secondary Outcome Measures
NameTimeMethod
<p>Secondary outcomes include time to first documented AF, incidence of recurrent<br /><br>stroke or TIA and change of oral anticoagulation regimen. Progression of the<br /><br>length and incidence of atrial fibrillation episodes. </p><br>
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