The Akershus Study of Ischemic Stroke and Thrombolysis -1

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorUniversity Hospital, Akershus

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

None

Trial 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)

Trial design

Design model

Cohort

Time perspective

Other

Treatments tested in this trial

Not listed

Trial groups

6,000 Participants
are grouped into 6 trial groups

6

Trial groups

See each trial group below.

Group A: Intravenous thrombolysis (IVT)
Group B: Intracerebral hemorrhage (ICH)
Group C: Acute ischemic stroke (AIS) and Intracerebral hemorrhage (ICH)
Group D: Stoke care pathway
Group E: Endovascular treatment
Group F: Cerebellar hematoma (cICH)

Trial outcomes

Primary outcomes

1

Large vessel occlusion in a representative Norwegian population

Incidence of large vessel occlusion 2015-2017

Time frame
Baseline 2015-2017
2

Functional status

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

Time frame
3 months
3

Functional status

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

Time frame
Index discharge from hospital, usually up to 1 month
4

Mortality

Number dead vs total number of cases all groups

Time frame
In-hospital, usually up to 1 month

Secondary outcomes

1

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

Time frame
Baseline 2015-2017
2

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)

Time frame
3 months
3

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

Mortality

Time frame
3 months
4

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)

Time frame
1 year

Other outcomes

Locations

1

Map coordinates are unavailable for these locations. Locations are shown below instead.

Akershus University HospitalRecruiting1478, LørenskogNorwayNorway

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University Hospital, Akershus

Lead sponsor

University of Oslo

Collaborator

Oslo University Hospital

Collaborator