The Akershus Study of Ischemic Stroke and Thrombolysis -1

NCT05378490 | Recruiting

• 1 other identifier: ASIST-1
• Study Type: observational
• Target: 6,000
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Outcome Measures

Primary Outcomes (9)

• Large vessel occlusion in a representative Norwegian population

  Incidence of large vessel occlusion 2015-2017

  Baseline 2015-2017

• Functional status

  modified Rankin Scale (mRS) 0-6 (0 normal, 6 dead) for all groups

  3 months

• Functional status

  modified Rankin Scale (mRS) 0-6 (0 normal, 6 dead) for all groups

  Index discharge from hospital, usually up to 1 month

• Mortality

  Number dead vs total number of cases all groups

  In-hospital, usually up to 1 month

• Mortality

  Number dead vs total number of cases all groups

  3 months

• Mortality

  Number dead vs total number of cases all groups

  12 months

• Mortality

  Number dead vs total number of cases all groups

  24 months

• Mortality

  Number dead vs total number of cases all groups

  5 years

• 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 Outcomes (22)

• Reasons for not giving thrombolysis in patients with acute stroke symptoms < 4.5 hours

  Baseline 2015-2017

• Functional outcome of patients in the stroke fast track treated or not treated with thrombolysis (or endovascular thrombectomy),

  3 months

• Mortality of patients in the stroke fast track treated or not treated with thrombolysis (or endovascular thrombectomy),

  3 months

• Functional outcome after 1 year of patients in the stroke fast track treated or not treated with thrombolysis (or endovascular thrombectomy),

  1 year

• Mortality after 1 year of patients in the stroke fast track treated or not treated with thrombolysis (or endovascular thrombectomy),

  1 year

Study Arms (6)

Intravenous thrombolysis (IVT)

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

Intracerebral hemorrhage (ICH)

All patients with intracerebral hemorrhage 2012-2019

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

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

Stoke care pathway

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

Endovascular treatment

All stroke patients treated with endovascular treatment 2012-2025

Cerebellar hematoma (cICH)

All patients with cerebellar hematoma 2008-2019

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

1. IVT treated patients 2012-2025 (2012-2018 retrospective, 2019-2025 prospective) 2. All patients with ICH (2011-2019 retrospective, 2020-2025 prospective) 3. All patients with acute ischemic stroke or ICH (2015-2018 retrospective, 2019-2025 prospective) 4. All patients admitted to the stroke care pathway (stroke/mimics 2015-2017) 5. All stroke patients treated with endovascular treatment 2012-2025 (2012-2018 retrospective, 2019-2025 prospective) 6. All patients with cerebellar hematoma 2008-2022 (retrospective) Data will be linked with data from general practitioners, Municipal Patient Registry (KRP/KUHR), Norwegian Patient Registry (NPR), Norwegian Prescription Database (NorPD), Norwegian Stroke registry, Cause of Death Registry (DÅR)

You may qualify if:

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

You may not qualify if:

• None

Sponsors & Collaborators

• University Hospital, Akershus: lead
• University of Oslo: collaborator
• Oslo University Hospital: collaborator

Study Sites (1)

Akershus University Hospital

Lørenskog, 1478, Norway

RECRUITING

Related 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 21.

  PMID: 35445395 BACKGROUND

• 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.

  PMID: 36252098 BACKGROUND

• 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.

  PMID: 36870965 BACKGROUND

• 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.

  PMID: 36807495 BACKGROUND

• 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.

  PMID: 37840934 BACKGROUND

MeSH Terms

Conditions

Stroke; Cerebral Hemorrhage; Ischemic Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Intracranial Hemorrhages; Hemorrhage; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Espen S. Kristoffersen, MD, PhD

  University Hospital, Akershus

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Espen S. Kristoffersen, MD, PhD

CONTACT

e.s.kristoffersen@medisin.uio.no

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: OTHER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate professor, MD, PhD

Study Record Dates

• First Submitted: January 19, 2022
• First Posted: May 18, 2022
• Study Start: January 1, 2012
• Primary Completion: December 31, 2025
• Study Completion (Estimated): December 31, 2040
• Last Updated: February 5, 2025

Record last verified: 2025-02

Locations

NO (1)