Stroke
Conditions
Keywords
ischemic stroke, ECG monitoring, atrial fibrillation (/flutter)
Brief summary
The purpose of this study is to assess whether repeated enhanced and prolonged ECG monitoring after ischemic stroke results in a higher detection of atrial fibrillation (/flutter) compared to usual care (at least 24 hour of cardiac monitoring).
Interventions
10-day Holter ECG measurement
OTHERstandard care
Usual care according to current guidelines (minimum of 24 hours of cardiac monitoring).
Sponsors
Institut fuer anwendungsorientierte Forschung und klinische Studien GmbH
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
60 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Recent cerebral ischemia defined as stroke (sudden focal neurologic deficit lasting \> 24h consistent with the territory of a major cerebral artery and categorised as ischemic) and/or a corresponding lesion on brain imaging. * Stroke symptoms started ≤ 7 days ago. * Age ≥ 60 years. * Modified Rankin scale ≤ 2 (prior to index event).
Exclusion criteria
* Known history of atrial fibrillation/flutter or atrial fibrillation/flutter on admission ECG. * Indication for oral anticoagulation at randomisation. * Absolute contra-indication against oral anticoagulation at randomisation. * Intracerebral bleeding in medical history. * Patient scheduled for Holter-ECG or cardiac Event-Recording monitoring ≥ 48 hours. * Significant carotid artery or vertebral artery stenosis \> 50% (NASCET classification), significant intracranial artery stenosis suspicious of atherosclerotic origin or acute arterial dissection explanatory of stroke symptoms. * Implanted pacemaker device or cardioverter/defibrillator. * Life expectancy \< 1 year for reasons other than stroke (e.g. metastatic cancer). * Concomitant participation in other controlled randomised trial.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| number of atrial fibrillation/flutter | 30 month after study start | The primary endpoint is the detection of newly diagnosed atrial fibrillation/flutter within 6 months and before occurrence of recurrent stroke or systemic embolism in the treatment group compared to control group. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| number of recurrent stroke or systemic embolism | 24 months after study start | Recurrent stroke or systemic embolism within 12 months after patient's inclusion. As patients are recruited for 12 months, this outcome measure is determined 24 months after study start. |
| total mortality | 24 months after study start | Total death within 12 months after patient's inclusion. As patients are recruited for 12 months, this outcome measure is determined 24 months after study start. |
| number of cardiovascular deaths | 24 months after study start | — |
| number of atrial fibrillation (/flutter) within 12 months after patient's inclusion | 24 months after study start | Detection of newly diagnosed atrial fibrillation (/flutter) as defined for the primary endpoint but within 12 months after patient's inclusion. As patients are recruited for 12 months, this outcome measure is determined 24 months after study start. |
| number of cerebrovascular deaths | 24 months after study start | — |
| number of transient ischemic attacks | 24 months after study start | — |
| number of atrial fibrillation (/flutter) without hospitalisation | 30 months after study start | Detection of newly diagnosed atrial fibrillation (/flutter) as defined for the primary endpoint with the exception that hospitalisation for atrial fibrillation (/flutter) will be considered as censoring. |
| number of bleeding complications | 24 months after study start | — |
| quality of life | 24 months after study start | — |
| number of atrial fibrillation (/flutter) in extended monitoring period | 24 months after study start | Incremental detection of atrial fibrillation (/flutter) in the extended Holter monitoring periods after 3 and 6 months. |
| costs | 24 months after study start | — |
| number of correct monitorings | 24 months after study start | To assess the feasibility of monitoring procedures. |
| number of myocardial infarctions | 24 months after study start | — |
Countries
Germany
Outcome results
None listed