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The aim of this study is to evaluate the role of atrial fibrillation (AF) and its treatment in relation to thromboembolic events (stroke, and transient ischemic attacks) and intracranial hemorrhage.
Primary Outcome Measures:
- Incidence and timing of intracranial complications (stroke,TIA, bleedings) in relation to diagnosis and anticoagulation treatment of AF during the study period; comparison of complications between those with and without anticoagulation treatment according to CHADSVASc score.
Secondary Outcome Measures:
Estimated Enrollment: 6000 patients.
Approximately 20% of stroke is caused by atrial fibrillation (AF) and 1% of patients with AF suffer from intracranial hemorrhage. Thus, the net benefit of AF management is the key factor in choosing the successful treatment (pharmacological and interventional).
In this retrospective Finnish multicenter study the investigators collect data on patients with intracranial thromboembolic events or intracranial hemorrhage and AF during the study period. All such patients ≥18 years of age are identified and relevant clinical details are retrospectively gathered from the hospital records of the participating hospitals into an internet-based CRF. The total study period is from 2003 to 2012.
All case records are reviewed using standardized data collection protocol to get information on baseline characteristics and medication of the patients, management of the patients before and during the index complication and during a 30-day follow-up after each complication.
Diagnosis of atrial fibrillation is based 12-lead electrocardiography according to the standard criteria.
Stroke is documented clinically and confirmed by computerized tomography or magnetic resonance imaging to be caused by cerebral infarction. Diagnosis of transient ischemic attacks are based on clinical diagnosis by neurologist when stroke is not confirmed by imaging. After completion of manual registration of data, a computer-based cross-checking of strokes is performed from discharge register data of the included patients to ensure the complete coverage of all events. Diagnosis of inctracranial bleedings are based on patient record and classified as subdural, subarachnoidal and intracerebral and possible preceding trauma is registered. Outcome measures are classified by study neurologist when necessary.
Antigoagulation treatment, INR levels during the index complication, possible pauses in treatment and their casues are registered togethr with information on antiplatelet treatments.
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| Measure | Description | Time Frame |
|---|---|---|
| Incidence of intracranial complications in relation to diagnosis and anticoagulation treatment of AF during the study period. | up to 9 years |
| Measure | Description | Time Frame |
|---|---|---|
| The number and the timing of TIAs and strokes in relation to anticoagulation pauses. | up to 9 years |
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Inclusion Criteria:
Exclusion Criteria:
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All patients aged 18 or over, hospitalized or having emergency unit visit during the study period because of thromboembolic event (stroke, TIA) or intracranial hemorrhage and having the diagnosis of atrial fibrillation.
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| Name | Affiliation | Role |
|---|---|---|
| Juhani Airaksinen, Professor | Turku University Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Keski-Suomi Central Hospital | Jyväskylä | Finland | ||||
| Kuopio University Hospital |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 30140582 | Derived | Lehtola H, Palomaki A, Mustonen P, Hartikainen P, Kiviniemi T, Sallinen H, Nuotio I, Ylitalo A, Airaksinen KEJ, Hartikainen J. Traumatic and spontaneous intracranial hemorrhage in atrial fibrillation patients on warfarin. Neurol Clin Pract. 2018 Aug;8(4):311-317. doi: 10.1212/CPJ.0000000000000491. |
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| ID | Term |
|---|---|
| D020521 | Stroke |
| D002546 | Ischemic Attack, Transient |
| D020300 | Intracranial Hemorrhages |
| D001281 | Atrial Fibrillation |
| D006470 | Hemorrhage |
| D013923 | Thromboembolism |
| ID | Term |
|---|---|
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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| Kuopio |
| Finland |
| Satakunta Central Hospital | Pori | Finland |
| Turku University Hospital | Turku | 20521 | Finland |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D002545 | Brain Ischemia |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D001145 | Arrhythmias, Cardiac |
| D006331 | Heart Diseases |
| D016769 | Embolism and Thrombosis |