The Akershus Study of Ischemic Stroke and Thrombolysis -1

Stroke, Acute Clinical Trial

— ASIST-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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05378490
• Other study ID #: ASIST-1
• Status: Recruiting
• Start date: January 1, 2012
• Est. completion date: December 31, 2040

Study information

• Verified date: November 2023
• Source: University Hospital, Akershus
• Contact: Espen S. Kristoffersen, MD, PhD
• Email: e.s.kristoffersen[@]medisin.uio.no
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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 information / eligibility

• Status: Recruiting
• Enrollment: 6000
• Est. completion date: December 31, 2040
• Est. primary completion date: December 31, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

• None

Related Conditions & MeSH terms

• Cerebral Hemorrhage
• Hemorrhage
• Intracerebral Hemorrhage
• Ischemia
• Ischemic Stroke
• Stroke
• Stroke, Acute
• Stroke, Ischemic
• TIA

Locations

Country	Name	City	State
Norway	Akershus University Hospital	Lørenskog

Sponsors (3)

Lead Sponsor	Collaborator
University Hospital, Akershus	Oslo University Hospital, University of Oslo

Country where clinical trial is conducted

Norway, 

References & Publications (5)

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 — View 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: 1 — View 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: 10.11 — View 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 — View Citation

Meinel TR, Wilson D, Gensicke H, Scheitz JF, Ringleb P, Goganau I, Kaesmacher J, Bae HJ, Kim DY, Kermer P, Suzuki K, Kimura K, Macha K, Koga M, Wada S, Altersberger V, Salerno A, Palanikumar L, Zini A, Forlivesi S, Kellert L, Wischmann J, Kristoffersen ES — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Large vessel occlusion in a representative Norwegian population	Incidence of large vessel occlusion 2015-2017	Baseline 2015-2017
Primary	Functional status	modified Rankin Scale (mRS) 0-6 (0 normal, 6 dead) for all groups	3 months
Primary	Functional status	modified Rankin Scale (mRS) 0-6 (0 normal, 6 dead) for all groups	Index discharge from hospital, usually up to 1 month
Primary	Mortality	Number dead vs total number of cases all groups	In-hospital, usually up to 1 month
Primary	Mortality	Number dead vs total number of cases all groups	3 months
Primary	Mortality	Number dead vs total number of cases all groups	12 months
Primary	Mortality	Number dead vs total number of cases all groups	24 months
Primary	Mortality	Number dead vs total number of cases all groups	5 years
Primary	Diagnostic precision of different published clinical screening scales of stroke and large vessel occlusion	Diagnostic precision, accuracy and validity of clinical screening scales	Baseline 2015-2017
Secondary	Reasons for not giving thrombolysis in patients with acute stroke symptoms < 4.5 hours	Number of cases treated with thrombolysis vs number of cases evaluated in the acute stroke care pathway	Baseline 2015-2017
Secondary	Functional outcome of patients in the stroke fast track treated or not treated with thrombolysis (or endovascular thrombectomy),	Modified Rankin Scale (mRS) 0-6 (0 normal, 6 dead)	3 months
Secondary	Mortality of patients in the stroke fast track treated or not treated with thrombolysis (or endovascular thrombectomy),	Mortality	3 months
Secondary	Functional outcome after 1 year of patients in the stroke fast track treated or not treated with thrombolysis (or endovascular thrombectomy),	modified Rankin Scale (mRS) 0-6 (0 normal, 6 dead)	1 year
Secondary	Mortality after 1 year of patients in the stroke fast track treated or not treated with thrombolysis (or endovascular thrombectomy),	Mortality	1 year
Secondary	Functional outcome at discharge of patients in the stroke fast track treated or not treated with thrombolysis (or endovascular thrombectomy),	modified Rankin Scale (mRS) 0-6 (0 normal, 6 dead)	Discharge after index admission, usually up to 1 month
Secondary	Mortality at discharge of patients in the stroke fast track treated or not treated with thrombolysis (or endovascular thrombectomy),	Mortality	Discharge after index admission, usually up to 1 month
Secondary	Re-admission	Number of new re-admission among included patients	Baseline to five years
Secondary	New prescriptions	Type of new prescriptions	Baseline to five years
Secondary	Use of anti-coagulation in the long-term	Number of patients treated with anti-coagulation	Baseline to five years
Secondary	Use of anti-platelet therapy in the long-term	Number of patients treated with anti-platelet therapy	Baseline to five years
Secondary	Use of cholesterol-lowering drugs in the long-term	Number of patients treated with cholesterol-lowering drugs	Baseline to five years
Secondary	Use of anti-hypertensive drugs in the long-term	Number of patients treated with anti-hypertensive drugs	Baseline to five years
Secondary	Use of anti-diabetics in the long-term	Number of patients treated with anti-diabetics	Baseline to five years
Secondary	Health care utilisation	Number of new health care system contacts	Baseline to five years
Secondary	Prehospital delay	Changes in prehospital delay (minutes)	2012-2025
Secondary	Time of stroke fast track	Changes in the use of stroke fast track (minutes)	2012-2025
Secondary	Use of stroke fast track	Changes in the use of stroke pathways (proportion)	2012-2025
Secondary	Treated in the stroke fast track	Changes in proportion treated over time	2012-2025
Secondary	Blood pressure variability baseline (diastolic, systolic and pulse pressure)	Different BP measurements from general practitioners, ambulance, hospital and follow-up	Baseline
Secondary	Blood pressure variability discharge after index (diastolic, systolic and pulse pressure)	Different BP measurements from general practitioners, ambulance, hospital and follow-up	Discharge after index admission, usually up to 1 month
Secondary	Blood pressure variability follow-up (diastolic, systolic and pulse pressure)	Different BP measurements from general practitioners, ambulance, hospital and follow-up	Follow-up (3 to 6 months)