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| Name | Class |
|---|---|
| Aalto University | OTHER |
| University of Turku | OTHER |
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The aim of FINACAF study is to evaluate the incidence and risk of stroke, systemic thromboembolic events, myocardial infarction, major bleeding events, and mortality in relation to different attitudes regarding stroke prevention treatment among AF patients.
The study with cohort design is conducted as a nationwide retrospective register-based linkage study using data obtained from the Finnish health care registers.
Atrial fibrillation (AF) is the most common sustained arrhythmia, its prevalence increases with age, and it presents with a wide spectrum of symptoms and severity. It has been estimated that number of AF patients is about 150 000 in Finland, and this number will be increased at least two-fold until year 2050.
The aim of this study is to evaluate the incidence and risk of stroke, systemic thromboembolic events, myocardial infarction, major bleeding events, and mortality in relation to different attitudes regarding stroke prevention treatment among AF patients.
An important part of the study is also the assessment of cost effectiveness of different OAC therapies. The risks mentioned above are separately evaluated with different management levels of warfarin therapy as well as with different NOACs and in patients without OAC treatment. The study population is also characterized according to co-morbidity, interactive medications and antiarhythmic drugs in use.
The study with cohort design is conducted as a nationwide retrospective register-based linkage study using data obtained from the Finnish health care registers. The study cohort consists of patients from six hospital district areas having a diagnosis of AF. The catchment population of these six districts is about 3.5 million; 64 % of the total Finnish population 5.5 million.
The study is register-based and patients will not be contacted in any phase of the study. Thus, no patient consents will be needed according to Finnish legislation. All patient data handled by the researchers will anonymous, ensuring full data protection of the patients.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| FinACAF cohort | The study cohort consists of all patients with AF diagnosis (ICD-10 I48) living in Finland during 1.1.2004-31.12.2018. The study cohort is obtained from data of Finnish national registries. Patients with permanent residence in Finland less than 12 months prior to index date are excluded from the study. |
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| Measure | Description | Time Frame |
|---|---|---|
| Mortality | All-cause, stroke, myocardial infarction,systemic thromboembolic events, bleeding events | Follow-up period 1/2004-12/2018 |
| Bleeding events | Intracranial hemorrage, Gastrointestinal hemorrage, other major bleeding events | Follow-up period 1/2004-12/2018 |
| Ischemic Stroke | ICD-10: I63, I64, I693-I698, G45 | Follow-up period 1/2004-12/2018 |
| Myocardial infarction | ICD-10: I21, I22 | Follow-up period 1/2004-12/2018 |
| Systemic Thromboembolism | Other than stroke or myocardial infarction | Follow-up period 1/2004-12/2018 |
| Measure | Description | Time Frame |
|---|---|---|
| Anemia | Decrement of haemoglobin during follow-up period. Detailed description available in Statistical Analysis plan under secondary objectives. | Follow-up period 1/2004-12/2018 |
| Renal failure |
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Inclusion Criteria:
Subject has an International Classification of Diseases (ICD-10 version 10) diagnosis code I48 for AF during 1.1.2004-31.12.2018 in any of the used registries
Exclusion Criteria:
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The study population consists of all AF patients of the study region (Six pre-selected hospital districts with laboratory data available) during 1.1.2004-31.06.2018, including newly diagnosed patients with ICD-10 I48 diagnose code.
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| Name | Affiliation | Role |
|---|---|---|
| Mika Lehto, MD,PhD | Helsinki University Central Hospital | Principal Investigator |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 42267424 | Derived | Palomaki A, Langen V, Airaksinen KEJ, Halminen O, Haukka J, Jaakkola J, Kouki E, Salmela B, Putaala J, Linna M, Mustonen P, Aro AL, Hartikainen J, Lehto M, Teppo K. Gout and Risk of Ischemic Stroke in Patients With Atrial Fibrillation: A Nationwide Cohort Study. Stroke. 2026 Jun 10. doi: 10.1161/STROKEAHA.126.055194. Online ahead of print. | |
| 41057675 |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Jul 2, 2024 | Jul 21, 2024 | Prot_001.pdf |
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| ID | Term |
|---|---|
| D001281 | Atrial Fibrillation |
| ID | Term |
|---|---|
| D001145 | Arrhythmias, Cardiac |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D010335 | Pathologic Processes |
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Time to renal impairment is defined as the time from index date to time when serum creatinine level is under the reference value.
| Follow-up period 1/2004-12/2018 |
| Dementia | Time to dementia diagnosis in patients without pre-existing dementia, ICD: F00,F01, F02, F03 | 1/2004-12/2018 |
| Healthcare Service costs | The Diagnosis-Related Groups (DRG) are based on the Finnish version of the Nordic Classification of Surgical Procedures codes for diagnostic and treatment procedures, and the respective Nordic Diagnosis-Related Groups patient classifications. Respectively, the patient-level data for primary care (with diagnosis and activity information) are grouped using the Ambulatory and Primary Care-Related Patient Groups (APR) grouper, a grouping system equivalent to DRG used in hospital care. The detailed description available in Statistical Analysis plan under secondary objectives. | 1/2004-12/2018 |
| Lehtonen O, Halminen O, Airaksinen KEJ, Haukka J, Putaala J, Mustonen P, Teppo K, Kouki E, Aro AL, Hartikainen J, Lehto M, Linna M. Cost Differences Between Oral Anticoagulation Therapies in Patients with Atrial Fibrillation in Finland. Drugs Real World Outcomes. 2025 Dec;12(4):631-641. doi: 10.1007/s40801-025-00519-5. Epub 2025 Oct 7. |
| 40366898 | Derived | Lehto J, Bjorn R, Halminen O, Linna M, Haukka J, Putaala J, Mustonen P, Kinnunen J, Hartikainen J, Airaksinen JKE, Kiviniemi TO, Lehto M. Quality of anticoagulation and outcomes after mechanical aortic valve replacement in patients with atrial fibrillation: a nationwide cohort study. Eur Heart J Qual Care Clin Outcomes. 2025 Aug 11;11(5):654-664. doi: 10.1093/ehjqcco/qcaf028. |
| 37119067 | Derived | Teppo K, Airaksinen KEJ, Biancari F, Jaakkola J, Halminen O, Linna M, Haukka J, Putaala J, Mustonen P, Kinnunen J, Luojus A, Hartikainen J, Aro AL, Lehto M. Aortic Stenosis and Outcomes in Patients With Atrial Fibrillation: A Nationwide Cohort Study. J Am Heart Assoc. 2023 May 2;12(9):e029337. doi: 10.1161/JAHA.122.029337. Epub 2023 Apr 29. |
| 36414332 | Derived | Lehto M, Haukka J, Aro A, Halminen O, Putaala J, Linna M, Mustonen P, Kinnunen J, Kouki E, Niiranen J, Luojus A, Tiili P, Itainen-Stromberg S, Hartikainen J, Airaksinen JKE; FinACAF study group. Comprehensive nationwide incidence and prevalence trends of atrial fibrillation in Finland. Open Heart. 2022 Nov;9(2):e002140. doi: 10.1136/openhrt-2022-002140. |
| 36041755 | Derived | Teppo K, Jaakkola J, Biancari F, Halminen O, Putaala J, Mustonen P, Haukka J, Linna M, Kinnunen J, Luojus A, Itainen-Stromberg S, Penttila T, Niemi M, Hartikainen J, Airaksinen KJ, Lehto M. Mental health conditions and use of rhythm control therapies in patients with atrial fibrillation: a nationwide cohort study. BMJ Open. 2022 Aug 30;12(8):e059759. doi: 10.1136/bmjopen-2021-059759. |
| 35705362 | Derived | Biancari F, Teppo K, Jaakkola J, Halminen O, Linna M, Haukka J, Putaala J, Mustonen P, Kinnunen J, Hartikainen J, Aro A, Airaksinen J, Lehto M. Income and outcomes of patients with incident atrial fibrillation. J Epidemiol Community Health. 2022 Jun 15;76(8):736-42. doi: 10.1136/jech-2022-219190. Online ahead of print. |
| 35229612 | Derived | Teppo K, Jaakkola J, Airaksinen KEJ, Biancari F, Halminen O, Putaala J, Mustonen P, Haukka J, Hartikainen J, Luojus A, Niemi M, Linna M, Lehto M. Mental Health Conditions and Nonpersistence of Direct Oral Anticoagulant Use in Patients With Incident Atrial Fibrillation: A Nationwide Cohort Study. J Am Heart Assoc. 2022 Mar 15;11(6):e024119. doi: 10.1161/JAHA.121.024119. Epub 2022 Mar 1. |
| D013568 |
| Pathological Conditions, Signs and Symptoms |