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The Akershus Study of Ischemic Stroke and Thrombolysis -1

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

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05378490
Acronym
ASIST-1
Enrollment
6000
Registered
2022-05-18
Start date
2012-01-01
Completion date
2040-12-31
Last updated
2025-02-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Intracerebral Hemorrhage, Stroke, Acute, Stroke, Ischemic, TIA

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).

Interventions

None listed

Sponsors

University of Oslo
CollaboratorOTHER
Oslo University Hospital
CollaboratorOTHER
University Hospital, Akershus
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
OTHER

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

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

Exclusion criteria

* None

Design outcomes

Primary

MeasureTime frameDescription
Large vessel occlusion in a representative Norwegian populationBaseline 2015-2017Incidence of large vessel occlusion 2015-2017
Functional status3 monthsmodified Rankin Scale (mRS) 0-6 (0 normal, 6 dead) for all groups
MortalityIn-hospital, usually up to 1 monthNumber dead vs total number of cases all groups
Diagnostic precision of different published clinical screening scales of stroke and large vessel occlusionBaseline 2015-2017Diagnostic precision, accuracy and validity of clinical screening scales

Secondary

MeasureTime frameDescription
Mortality after 1 year of patients in the stroke fast track treated or not treated with thrombolysis (or endovascular thrombectomy),1 yearMortality
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 monthmodified Rankin Scale (mRS) 0-6 (0 normal, 6 dead)
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 monthMortality
Re-admissionBaseline to five yearsNumber of new re-admission among included patients
New prescriptionsBaseline to five yearsType of new prescriptions
Use of anti-coagulation in the long-termBaseline to five yearsNumber of patients treated with anti-coagulation
Use of anti-platelet therapy in the long-termBaseline to five yearsNumber of patients treated with anti-platelet therapy
Use of cholesterol-lowering drugs in the long-termBaseline to five yearsNumber of patients treated with cholesterol-lowering drugs
Use of anti-hypertensive drugs in the long-termBaseline to five yearsNumber of patients treated with anti-hypertensive drugs
Reasons for not giving thrombolysis in patients with acute stroke symptoms < 4.5 hoursBaseline 2015-2017Number of cases treated with thrombolysis vs number of cases evaluated in the acute stroke care pathway
Health care utilisationBaseline to five yearsNumber of new health care system contacts
Prehospital delay2012-2025Changes in prehospital delay (minutes)
Time of stroke fast track2012-2025Changes in the use of stroke fast track (minutes)
Use of stroke fast track2012-2025Changes in the use of stroke pathways (proportion)
Treated in the stroke fast track2012-2025Changes in proportion treated over time
Blood pressure variability baseline (diastolic, systolic and pulse pressure)BaselineDifferent 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 monthDifferent BP measurements from general practitioners, ambulance, hospital and follow-up
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
Use of anti-diabetics in the long-termBaseline to five yearsNumber of patients treated with anti-diabetics
Functional outcome of patients in the stroke fast track treated or not treated with thrombolysis (or endovascular thrombectomy),3 monthsModified Rankin Scale (mRS) 0-6 (0 normal, 6 dead)
Mortality of patients in the stroke fast track treated or not treated with thrombolysis (or endovascular thrombectomy),3 monthsMortality
Functional outcome after 1 year of patients in the stroke fast track treated or not treated with thrombolysis (or endovascular thrombectomy),1 yearmodified Rankin Scale (mRS) 0-6 (0 normal, 6 dead)

Countries

Norway

Contacts

Primary ContactEspen S. Kristoffersen, MD, PhD
e.s.kristoffersen@medisin.uio.no

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026