Clinical trial NCT05378490: The Akershus Study of Ischemic Stroke and Thrombolysis -1
Official title: The Akershus Study of Ischemic Stroke and Thrombolysis -1 (ASIST-1) Epidemiology, Clinical and Radiological Presentation and Treatment of Cerebrovascular Disease and Stroke Mimics in a Norwegian Population
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Stroke, Acute
Intracerebral Hemorrhage
Stroke, Ischemic
TIA
Lead sponsor: University Hospital, Akershus
Sponsor class: OTHER
Collaborators: name: University of Oslo
name: Oslo University Hospital
First posted: 2022-05-18
Enrollment: 6000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: OTHER
Sampling method: PROBABILITY_SAMPLE
Study population: 1. IVT treated patients 2012-2025 (2012-2018 retrospective, 2019-2025 prospective)
2. All patients with ICH (2011-2019 retrospective, 2020-2025 prospective)
3. All patients with acute ischemic stroke or ICH (2015-2018 retrospective, 2019-2025 prospective)
4. All patients admitted to the stroke care pathway (stroke/mimics 2015-2017)
5. All stroke patients treated with endovascular treatment 2012-2025 (2012-2018 retrospective, 2019-2025 prospective)
6. All patients with cerebellar hematoma 2008-2022 (retrospective)

Data will be linked with data from general practitioners, Municipal Patient Registry (KRP/KUHR), Norwegian Patient Registry (NPR), Norwegian Prescription Database (NorPD), Norwegian Stroke registry, Cause of Death Registry (DÅR)

Brief summary: This observational study comprises consecutively patients with cerebrovascular diseases admitted to the Stroke Unit at Akershus University Hospital in Norway. Akershus University Hospital is the largest emergency care hospital in Norway and has a catchment area covering a population of 550.000, which is approximately 10 % of the Norwegian population and reasonably representative according to data from Statistics Norway. The hospital is public and serving both as a primary hospital and a university hospital. Due to the Norwegian, national, all-covering health-insurance, all patients enter the hospital and are considered for further in-patient care on the same conditions. The hospital has a stroke unit classified as a comprehensive stroke center according to European Stroke Organisation standards. Acute stroke management follows national and international guidelines. Overall, the ASIST-1 study will investigate management, outcome and prognosis of stroke and stroke care pathways and later follow up in primary care using several approaches combining existing clinical data from a representative population with different Norwegian health registries. Parts of the study are retrospective with prospective follow-up by health registries and parts of the study are prospective.

Detailed description: Aims

i) to describe the use of the stroke fast track and the proportion of all those evaluated in the fast track actually treated with intravenous thrombolysis, ii) to identify reasons for not giving thrombolysis in patients with acute stroke symptoms \< 4.5 hours at admission to hospital, iii) to investigate whether or not some of these patients that did not receive thrombolysis actually could have been given thrombolysis, iv) to investigate the outcome of patients in the stroke fast track treated or not treated with thrombolysis (or endovascular thrombectomy), v) to investigate differences between stroke and stroke mimics for patients reaching the hospital within or outside the thrombolysis time window of 4.5 hours, vi) to investigate differences between stroke subtypes (both ischemic and hemorrhagic) and stroke mimics for patients reaching the hospital within or outside the thrombolysis time window of 4.5 hours, vii) to investigate outcomes for patients with acute ischemic stroke, hemorrhagic stroke, transient ischemic attack (TIA) or stroke mimics, viii) to investigate predictors and factors related to functional outcome for patients with acute ischemic stroke, hemorrhagic stroke, TIA or stroke mimics, ix) to describe the epidemiology of large vessel occlusions in a representative hospital population, x) to describe hemorrhagic stroke in a representative hospital population, xi) whether risk factors, acute blood pressure variability or imaging (CT, angiography, perfusion or MRI) may predict diagnosis or outcome at discharge, 3 months, 12 months and 2 years for the ASIST-1 population, xii) whether risk factors, acute blood pressure variability or imaging (CT, angiography, perfusion or MRI) may predict outcome at discharge, 3 months, 12 months and 2 years for different sub-types of stroke, xiii) to investigate readmission until 5 years after initial admission for acute stroke symptoms xiv) whether deep learning-based assessment of acute phase CT, CT perfusion and CT angiography can reliably identify infarct core, penumbra and large-vessel occlusion, estimate reliably collateral score, predict risk of adverse events, or guide target blood pressure during acute and subacute ischemic stroke specialized treatment, xv) whether deep learning-based assessment of acute phase CT, CT perfusion and CT angiography or MRI can predict clinical outcome in different types of stroke, xvi) whether deep learning-based assessment of acute phase CT, CT perfusion, CT angiography or MRI can be used for automatic detection of hematoma volume and localization in hemorrhagic stroke xvii) whether deep learning-based assessment of acute phase CT or MRI can predict risk of new incidents after a hemorrhagic stroke and thus guide the clinicians to whether or not patients should be started/re-started on anti-platelet therapy or anticoagulation xviii) to investigate secondary prevention after different subtypes of stroke and the adherence of statins, anti-platelet therapy, anti-coagulation and blood pressure treatment up to 5 years after stroke, also in relation to readmission rates and long-term mortality xix) to prospectively investigate quality in terms of treatment, complications, prognosis and predictive factors of all patients given thrombolysis and/or thrombectomy at Ahus 2019-2025 xx) to investigate the changes in prehospital delay, the use of stroke fast track, stroke pathways and treatment over time (2012-2025).

Eligibility criteria: Inclusion Criteria:

* Cerebrovascular diseases (acute ischemic stroke, intracerebral hemorrhage, transient ischemic attack) or stroke mimics

Exclusion Criteria:

* None

Primary outcomes:
measure: Large vessel occlusion in a representative Norwegian population
timeFrame: Baseline 2015-2017
measure: Functional status
timeFrame: 3 months
measure: Functional status
timeFrame: Index discharge from hospital, usually up to 1 month
measure: Mortality
timeFrame: In-hospital, usually up to 1 month
measure: Mortality
timeFrame: 3 months
measure: Mortality
timeFrame: 12 months
measure: Mortality
timeFrame: 24 months
measure: Mortality
timeFrame: 5 years
measure: Diagnostic precision of different published clinical screening scales of stroke and large vessel occlusion
timeFrame: Baseline 2015-2017
Secondary outcomes:
measure: Reasons for not giving thrombolysis in patients with acute stroke symptoms < 4.5 hours
timeFrame: Baseline 2015-2017
measure: Functional outcome of patients in the stroke fast track treated or not treated with thrombolysis (or endovascular thrombectomy),
timeFrame: 3 months
measure: Mortality of patients in the stroke fast track treated or not treated with thrombolysis (or endovascular thrombectomy),
timeFrame: 3 months
measure: Functional outcome after 1 year of patients in the stroke fast track treated or not treated with thrombolysis (or endovascular thrombectomy),
timeFrame: 1 year
measure: Mortality after 1 year of patients in the stroke fast track treated or not treated with thrombolysis (or endovascular thrombectomy),
timeFrame: 1 year
measure: Functional outcome at discharge of patients in the stroke fast track treated or not treated with thrombolysis (or endovascular thrombectomy),
timeFrame: Discharge after index admission, usually up to 1 month
measure: Mortality at discharge of patients in the stroke fast track treated or not treated with thrombolysis (or endovascular thrombectomy),
timeFrame: Discharge after index admission, usually up to 1 month
measure: Re-admission
timeFrame: Baseline to five years
measure: New prescriptions
timeFrame: Baseline to five years
measure: Use of anti-coagulation in the long-term
timeFrame: Baseline to five years
measure: Use of anti-platelet therapy in the long-term
timeFrame: Baseline to five years
measure: Use of cholesterol-lowering drugs in the long-term
timeFrame: Baseline to five years
measure: Use of anti-hypertensive drugs in the long-term
timeFrame: Baseline to five years
measure: Use of anti-diabetics in the long-term
timeFrame: Baseline to five years
measure: Health care utilisation
timeFrame: Baseline to five years
measure: Prehospital delay
timeFrame: 2012-2025
measure: Time of stroke fast track
timeFrame: 2012-2025
measure: Use of stroke fast track
timeFrame: 2012-2025
measure: Treated in the stroke fast track
timeFrame: 2012-2025
measure: Blood pressure variability baseline (diastolic, systolic and pulse pressure)
timeFrame: Baseline
measure: Blood pressure variability discharge after index (diastolic, systolic and pulse pressure)
timeFrame: Discharge after index admission, usually up to 1 month
measure: Blood pressure variability follow-up (diastolic, systolic and pulse pressure)
timeFrame: Follow-up (3 to 6 months)
Other outcomes:
Locations:
city: Lørenskog
country: Norway
facility: Akershus University Hospital
Study officials:
affiliation: University Hospital, Akershus
name: Espen S. Kristoffersen, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Bergh E, Jahr SH, Ronning OM, Askim T, Thommessen B, Kristoffersen ES. Reasons and predictors of non-thrombolysis in patients with acute ischemic stroke admitted within 4.5 h. Acta Neurol Scand. 2022 Jul;146(1):61-69. doi: 10.1111/ane.13622. Epub 2022 Apr 21.
citation: Larsen KT, Selseth MN, Jahr SH, Hillestad V, Koubaa N, Sandset EC, Ronning OM, Kristoffersen ES. Prehospital Blood Pressure and Clinical and Radiological Outcomes in Acute Spontaneous Intracerebral Hemorrhage. Stroke. 2022 Dec;53(12):3633-3641. doi: 10.1161/STROKEAHA.121.038524. Epub 2022 Oct 17.
citation: Larsen KT, Sandset EC, Selseth MN, Jahr SH, Koubaa N, Hillestad V, Kristoffersen ES, Ronning OM. Antithrombotic Treatment, Prehospital Blood Pressure, and Outcomes in Spontaneous Intracerebral Hemorrhage. J Am Heart Assoc. 2023 Mar 7;12(5):e028336. doi: 10.1161/JAHA.122.028336. Epub 2023 Mar 4.
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citation: MacIntosh BJ, Liu Q, Schellhorn T, Beyer MK, Groote IR, Morberg PC, Poulin JM, Selseth MN, Bakke RC, Naqvi A, Hillal A, Ullberg T, Wasselius J, Ronning OM, Selnes P, Kristoffersen ES, Emblem KE, Skogen K, Sandset EC, Bjornerud A. Radiological features of brain hemorrhage through automated segmentation from computed tomography in stroke and traumatic brain injury. Front Neurol. 2023 Sep 28;14:1244672. doi: 10.3389/fneur.2023.1244672. eCollection 2023.