The Akershus Study of Ischemic Stroke and Thrombolysis -1

NCT ID: NCT05378490

Last Updated: 2025-02-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

6000 participants

Study Classification

OBSERVATIONAL

Study Start Date

2012-01-01

Study Completion Date

2040-12-31

Brief Summary

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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

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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).

Conditions

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Stroke, Acute Intracerebral Hemorrhage Stroke, Ischemic TIA

Study Design

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Observational Model Type

COHORT

Study Time Perspective

OTHER

Study Groups

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Intravenous thrombolysis (IVT)

All patients treated with IVT in the acute stroke care pathway 2012-2025

No interventions assigned to this group

Intracerebral hemorrhage (ICH)

All patients with intracerebral hemorrhage 2012-2019

No interventions assigned to this group

Acute ischemic stroke (AIS) and Intracerebral hemorrhage (ICH)

All patients with acute ischemic stroke or intracerebral hemorrhage 2015-2017

No interventions assigned to this group

Stoke care pathway

All patients admitted to the stroke care pathway (ischemic stroke, intracerebral hemorrhage, transient ischemic attack and stroke mimics) 2015-2017

No interventions assigned to this group

Endovascular treatment

All stroke patients treated with endovascular treatment 2012-2025

No interventions assigned to this group

Cerebellar hematoma (cICH)

All patients with cerebellar hematoma 2008-2019

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

* None
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Oslo

OTHER

Sponsor Role collaborator

Oslo University Hospital

OTHER

Sponsor Role collaborator

University Hospital, Akershus

OTHER

Sponsor Role lead

Responsible Party

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Espen Saxhaug Kristoffersen

Associate professor, MD, PhD

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Espen S. Kristoffersen, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

University Hospital, Akershus

Locations

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Akershus University Hospital

Lørenskog, , Norway

Site Status RECRUITING

Countries

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Norway

Central Contacts

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Espen S. Kristoffersen, MD, PhD

Role: CONTACT

Facility Contacts

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Espen S. Kristoffersen, MD, PhD

Role: primary

References

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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 21.

Reference Type BACKGROUND
PMID: 35445395 (View on PubMed)

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: 10.1161/STROKEAHA.121.038524. Epub 2022 Oct 17.

Reference Type BACKGROUND
PMID: 36252098 (View on PubMed)

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: 10.1161/JAHA.122.028336. Epub 2023 Mar 4.

Reference Type BACKGROUND
PMID: 36870965 (View on PubMed)

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, Beharry J, Barber PA, Hong JB, Cereda C, Schlemm E, Yakushiji Y, Poli S, Leker R, Romoli M, Zedde M, Curtze S, Ikenberg B, Uphaus T, Giannandrea D, Portela PC, Veltkamp R, Ranta A, Arnold M, Fischer U, Cha JK, Wu TY, Purrucker JC, Seiffge DJ; International DOAC-IVT, TRISP, and CRCS-K-NIH Collaboration; DOAC-IVT Writing Group; Kagi G, Engelter S, Nolte CH, Kallmunzer B, Michel P, Kleinig TJ, Fink J, Ronning OM, Campbell B, Nederkoorn PJ, Thomalla G, Kunieda T, Poli K, Bejot Y, Soo Y, Garcia-Esperon C, Ntaios G, Cordonnier C, Marto JP, Bigliardi G, Lun F, Choi PMC, Steiner T, Ustrell X, Werring D, Wegener S, Pezzini A, Du H, Marti-Fabregas J, Canovas-Verge D, Strbian D, Padjen V, Yaghi S, Stretz C, Kim JT. Intravenous Thrombolysis in Patients With Ischemic Stroke and Recent Ingestion of Direct Oral Anticoagulants. JAMA Neurol. 2023 Mar 1;80(3):233-243. doi: 10.1001/jamaneurol.2022.4782.

Reference Type BACKGROUND
PMID: 36807495 (View on PubMed)

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 brain hemorrhage through automated segmentation from computed tomography in stroke and traumatic brain injury. Front Neurol. 2023 Sep 28;14:1244672. doi: 10.3389/fneur.2023.1244672. eCollection 2023.

Reference Type BACKGROUND
PMID: 37840934 (View on PubMed)

Other Identifiers

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ASIST-1

Identifier Type: -

Identifier Source: org_study_id

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