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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05378490
Other study ID # ASIST-1
Secondary ID
Status Recruiting
Phase
First received
Last updated
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
Health authority
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

Study Design


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)
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