Stroke, Acute Clinical Trial
— ASIST-1Official 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
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 |
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.
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 |
Country | Name | City | State |
---|---|---|---|
Norway | Akershus University Hospital | Lørenskog |
Lead Sponsor | Collaborator |
---|---|
University Hospital, Akershus | Oslo University Hospital, University of Oslo |
Norway,
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
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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