The Akershus Study of Ischemic Stroke and Thrombolysis -1
- Conditions
- Stroke, IschemicStroke, AcuteIntracerebral HemorrhageTIA
- Registration Number
- NCT05378490
- Lead Sponsor
- University Hospital, Akershus
- 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).
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 6000
- Cerebrovascular diseases (acute ischemic stroke, intracerebral hemorrhage, transient ischemic attack) or stroke mimics
- None
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Functional status Index discharge from hospital, usually up to 1 month modified Rankin Scale (mRS) 0-6 (0 normal, 6 dead) for all groups
Large vessel occlusion in a representative Norwegian population Baseline 2015-2017 Incidence of large vessel occlusion 2015-2017
Diagnostic precision of different published clinical screening scales of stroke and large vessel occlusion Baseline 2015-2017 Diagnostic precision, accuracy and validity of clinical screening scales
Mortality 5 years Number dead vs total number of cases all groups
- Secondary Outcome Measures
Name Time Method Mortality of patients in the stroke fast track treated or not treated with thrombolysis (or endovascular thrombectomy), 3 months Mortality
Functional outcome after 1 year of patients in the stroke fast track treated or not treated with thrombolysis (or endovascular thrombectomy), 1 year modified Rankin Scale (mRS) 0-6 (0 normal, 6 dead)
Reasons for not giving thrombolysis in patients with acute stroke symptoms < 4.5 hours Baseline 2015-2017 Number of cases treated with thrombolysis vs number of cases evaluated in the acute stroke care pathway
Re-admission Baseline to five years Number of new re-admission among included patients
Mortality after 1 year of patients in the stroke fast track treated or not treated with thrombolysis (or endovascular thrombectomy), 1 year Mortality
Mortality at discharge of patients in the stroke fast track treated or not treated with thrombolysis (or endovascular thrombectomy), Discharge after index admission, usually up to 1 month Mortality
Functional outcome of patients in the stroke fast track treated or not treated with thrombolysis (or endovascular thrombectomy), 3 months Modified Rankin Scale (mRS) 0-6 (0 normal, 6 dead)
Use of anti-coagulation in the long-term Baseline to five years Number of patients treated with anti-coagulation
Use of cholesterol-lowering drugs in the long-term Baseline to five years Number of patients treated with cholesterol-lowering drugs
Functional outcome at discharge of patients in the stroke fast track treated or not treated with thrombolysis (or endovascular thrombectomy), Discharge after index admission, usually up to 1 month modified Rankin Scale (mRS) 0-6 (0 normal, 6 dead)
New prescriptions Baseline to five years Type of new prescriptions
Use of anti-platelet therapy in the long-term Baseline to five years Number of patients treated with anti-platelet therapy
Use of anti-hypertensive drugs in the long-term Baseline to five years Number of patients treated with anti-hypertensive drugs
Prehospital delay 2012-2025 Changes in prehospital delay (minutes)
Time of stroke fast track 2012-2025 Changes in the use of stroke fast track (minutes)
Treated in the stroke fast track 2012-2025 Changes in proportion treated over time
Blood pressure variability baseline (diastolic, systolic and pulse pressure) Baseline Different BP measurements from general practitioners, ambulance, hospital and follow-up
Blood pressure variability discharge after index (diastolic, systolic and pulse pressure) Discharge after index admission, usually up to 1 month Different BP measurements from general practitioners, ambulance, hospital and follow-up
Use of anti-diabetics in the long-term Baseline to five years Number of patients treated with anti-diabetics
Health care utilisation Baseline to five years Number of new health care system contacts
Use of stroke fast track 2012-2025 Changes in the use of stroke pathways (proportion)
Blood pressure variability follow-up (diastolic, systolic and pulse pressure) Follow-up (3 to 6 months) Different BP measurements from general practitioners, ambulance, hospital and follow-up
Trial Locations
- Locations (1)
Akershus University Hospital
🇳🇴Lørenskog, Norway