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| Name | Class |
|---|---|
| Haukeland University Hospital | OTHER |
| The Dam Foundation | OTHER |
| The Norwegian Women´s Public Health Association | OTHER |
| University of Oslo |
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The goal of this observational study is to investigate sex - differences in detection rate of atrial fibrillation after cryptogenic stroke (embolic stroke of unknown cause) - using an implantable cardiac rhythm monitor - and the treatment effects of oral anticoagulation on recurrent stroke, ischemic cardiovascular events, major bleeding risk, disability and mortality.
The main questions to answer are:
This is a prospective, observational, study including consecutive patiens with acute cryptogenic stroke /embolic stroke of unknown source (ESUS) or transient ischemic attack (TIA) admitted between 2016 and 2023 at Akershus University Hospital (AUH). As part of the standard investigation at AUH, selected patients are offered an implantable cardiac monitor (ICM) and followed up for detection of atrial fibrillation (AF) by a specialised neurocardiology team. A control group recruited at another hospital during the same period, Haukeland University Hospital (HUS), only comprise women.
The primary objectives:
Secondary objectives:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ICM group | Cryptogenic stroke/ESUS with insertable cardiac monitor for detection of atrial fibrillation | ||
| Control group | Non- invasive monitoring and standard of care. Women with cryptogenic stroke(ESUS) from another hospital |
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| Measure | Description | Time Frame |
|---|---|---|
| Atrial fibrillation deteceted after stroke and transient ischemic attack (TIA) | >30 seconds of atrial fibrillation detection using implantable cardiac monitor/implantable loop-recorder | 30 days and 1 year after index stroke |
| Recurrent ischemic stroke after 1 and 2 years | Ischemic stroke/TIA: Clinical diagnosis (TOAST criteria) verified by CT and/or MR. | 30 days, 1 and 2 years after index stroke |
| Measure | Description | Time Frame |
|---|---|---|
| Composite of stroke and mortality | Ischemic and heamorragic stroke, (ICD-10 I63 and I61) transient ischemic attack(TIA) (ICD10: G45.9) and mortality | 30 days, 1 and 2 years after index stroke |
| Intracranial bleeding |
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Inclusion Criteria:
Exclusion Criteria:
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In total 1050 patients. A cohort of at least 700 patients of both sexes diagnosed with acute cryptogenic stroke or TIA and with an implantable cardiac monitor, admitted to the stroke unit at Akershus University Hospital, Norway.
A control group of 350 women with acute cryptogenic stroke or TIA, with non-invasive standard monitoring, admitted to the stroke unit at Haukeland University Hospital.
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| Name | Affiliation | Role |
|---|---|---|
| Ole Morten Rønning, Professor | Akerhus University Hospital and University of Oslo | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Akershus University Hospital, Department of Neurology | Oslo | Lørenskog/Akershus | 1478 | Norway |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35819199 | Background | Skrebelyte-Strom L, Ronning OM, Dahl FA, Steine K, Kjekshus H. Prediction of occult atrial fibrillation in patients after cryptogenic stroke and transient ischaemic attack: PROACTIA. Europace. 2022 Dec 9;24(12):1881-1888. doi: 10.1093/europace/euac092. | |
| 41870212 | Derived | Koldeus-Falch J, Thommessen B, Sundseth A, Skrebelyte-Strom L, Naess H, Truscott Thomas OM, Ronning OM. Cryptogenic stroke in women: impact of insertable cardiac monitoring in the STROKEWISE cohort study. Europace. 2026 Mar 30;28(4):euag056. doi: 10.1093/europace/euag056. |
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Due to Norwegian regulations, the data cannot be shared publicly, and the authors are not permitted to share the data or study materials used in this study. De-identified datasets may be made available from the corresponding author upon reasonable request and with appropriate ethical and institutional approvals.
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| OTHER |
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Whole blood
Symptomatic intracranial heamorrage (stroke) (ICD-10: I61)
| 30 days, 1 and 2 years after index stroke |
| Patient Reported Outcome Measureres | Self-perceived health and health related quality of life by using the EuroQol scale (EQ-5D-5L) | 3 months after index stroke |
| Ischemic cardiac events | Hospitaized for ischemic cardiac events (ICD10 20-25) | 1 and 2 years |
| Safety outcome | Hospitalized for gastrointestinal bleeding (ICD 10 K92) and/or intracranial bleeding (I61) | 1 and 2 years after index stroke |
| Oral anticoagulation | Use of oral anticoagulation | 1 and 2 years |
| Functional outcome 3 months post-stroke | Functional outcome 3 months post-stroke using modified Rankin Scale (mRS) from the national stroke registry | 3 months after index stroke |
| ID | Term |
|---|---|
| D000083242 | Ischemic Stroke |
| D001281 | Atrial Fibrillation |
| D002561 | Cerebrovascular Disorders |
| D002318 | Cardiovascular Diseases |
| D001145 | Arrhythmias, Cardiac |
| D020521 | Stroke |
| D000083262 | Embolic Stroke |
| ID | Term |
|---|---|
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D014652 | Vascular Diseases |
| D006331 | Heart Diseases |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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