Stroke, AcuteASIST-1NCT05378490
The Akershus Study of Ischemic Stroke and Thrombolysis -1
An observational study of Stroke, Acute and Intracerebral Hemorrhage, run by University Hospital, Akershus at 1 site in Norway.
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Stroke, Acute, Intracerebral Hemorrhage, Stroke, Ischemic
- How many people
- 6,000 participants
- Where
- 1 siteNorway
- Study dates
- 1 Jan 2012to 31 Dec 2040
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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)
Who may be able to join
- Cerebrovascular diseases (acute ischemic stroke, intracerebral hemorrhage, transient ischemic attack) or stroke mimics
Who cannot join
- None
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Espen S. Kristoffersen, MD, PhD contact
Norway1 site, 1 recruiting
- Recruiting
Akershus University Hospital
Lørenskog, 1478
Espen S. Kristoffersen, MD, PhD, e.s.kristoffersen@medisin.uio.no
About this study
Official 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
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.
Read the detailed description
Aims
- 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
- Stroke, Acute, Intracerebral Hemorrhage, Stroke, Ischemic, TIA
- Medical subject headings
- Stroke, Cerebral Hemorrhage, Ischemic Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Large vessel occlusion in a representative Norwegian population
Incidence of large vessel occlusion 2015-2017
Measured: Baseline 2015-2017
Functional status
modified Rankin Scale (mRS) 0-6 (0 normal, 6 dead) for all groups
Measured: 3 months
Functional status
modified Rankin Scale (mRS) 0-6 (0 normal, 6 dead) for all groups
Measured: Index discharge from hospital, usually up to 1 month
Mortality
Number dead vs total number of cases all groups
Measured: In-hospital, usually up to 1 month
Mortality
Number dead vs total number of cases all groups
Measured: 3 months
Mortality
Number dead vs total number of cases all groups
Measured: 12 months
Mortality
Number dead vs total number of cases all groups
Measured: 24 months
Mortality
Number dead vs total number of cases all groups
Measured: 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
Measured: Baseline 2015-2017
Secondary outcomes (22)
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
Measured: Baseline 2015-2017
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)
Measured: 3 months
Mortality of patients in the stroke fast track treated or not treated with thrombolysis (or endovascular thrombectomy),
Mortality
Measured: 3 months
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)
Measured: 1 year
Mortality after 1 year of patients in the stroke fast track treated or not treated with thrombolysis (or endovascular thrombectomy),
Mortality
Measured: 1 year
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)
Measured: Discharge after index admission, usually up to 1 month
Mortality at discharge of patients in the stroke fast track treated or not treated with thrombolysis (or endovascular thrombectomy),
Mortality
Measured: Discharge after index admission, usually up to 1 month
Re-admission
Number of new re-admission among included patients
Measured: Baseline to five years
New prescriptions
Type of new prescriptions
Measured: Baseline to five years
Use of anti-coagulation in the long-term
Number of patients treated with anti-coagulation
Measured: Baseline to five years
Use of anti-platelet therapy in the long-term
Number of patients treated with anti-platelet therapy
Measured: Baseline to five years
Use of cholesterol-lowering drugs in the long-term
Number of patients treated with cholesterol-lowering drugs
Measured: Baseline to five years
Use of anti-hypertensive drugs in the long-term
Number of patients treated with anti-hypertensive drugs
Measured: Baseline to five years
Use of anti-diabetics in the long-term
Number of patients treated with anti-diabetics
Measured: Baseline to five years
Health care utilisation
Number of new health care system contacts
Measured: Baseline to five years
Prehospital delay
Changes in prehospital delay (minutes)
Measured: 2012-2025
Time of stroke fast track
Changes in the use of stroke fast track (minutes)
Measured: 2012-2025
Use of stroke fast track
Changes in the use of stroke pathways (proportion)
Measured: 2012-2025
Treated in the stroke fast track
Changes in proportion treated over time
Measured: 2012-2025
Blood pressure variability baseline (diastolic, systolic and pulse pressure)
Different BP measurements from general practitioners, ambulance, hospital and follow-up
Measured: Baseline
Blood pressure variability discharge after index (diastolic, systolic and pulse pressure)
Different BP measurements from general practitioners, ambulance, hospital and follow-up
Measured: Discharge after index admission, usually up to 1 month
Blood pressure variability follow-up (diastolic, systolic and pulse pressure)
Different BP measurements from general practitioners, ambulance, hospital and follow-up
Measured: Follow-up (3 to 6 months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 May 2022
- Study start1 Jan 2012
- Primary completion31 Dec 2025 (estimated)
- Study completion31 Dec 2040 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Stroke, AcuteStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Other
- Enrolment
- 6,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Akershus
- Sponsor type
- University, hospital or other
- Collaborators
- University of Oslo, Oslo University Hospital
- Responsible party
- Principal investigator, Espen Saxhaug Kristoffersen, University Hospital, Akershus
- Investigators
- Espen S. Kristoffersen, MD, PhD, Principal investigator, University Hospital, Akershus
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05378490
- Sponsor's protocol ID
- ASIST-1
- Acronym
- ASIST-1
- Status last verified
- Feb 2025
- First submitted
- 19 Jan 2022
- Last updated
- 5 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Could be possible, but must be approved by Medical Ethics Committee in Norway
Publications
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.
PubMed 35445395Larsen 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.
PubMed 36252098Larsen 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.
PubMed 36870965Meinel 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.
PubMed 36807495MacIntosh 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.
PubMed 37840934Jahr SH, Koubaa N, Hillestad V, Larsen KT, Selseth MN, Lied-Herland T, Sundseth J, Sandset EC, Ronning OM, Kristoffersen ES. Incidence, clinical characteristics and outcome of spontaneous cerebellar intracerebral haemorrhage in a Norwegian population. Eur Stroke J. 2026 Jul 6;11(7):aakag073. doi: 10.1093/esj/aakag073.
PubMed 42406909Jahr SH, Selseth MN, Larsen KT, Sabine Reichenbach A, Altmann M, Sundseth A, Hillestad V, Bugge HF, Braarud AC, Hov MR, Faiz KW, Ronning OM, Sandset EC, Kristoffersen ES. Diagnostic performance of prehospital large-vessel occlusion detection scales in patients with suspected acute stroke: a retrospective validation study. The Akershus Study of Ischemic Stroke and Thrombolysis. Eur Stroke J. 2026 Jun 2;11(6):aakag067. doi: 10.1093/esj/aakag067.
PubMed 42319233
Study at a glance
From the registry record, last updated by the sponsor on 5 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT05378490
- Acronym / sponsor ID
- ASIST-1 / ASIST-1
- Conditions
- Stroke, Acute, Intracerebral Hemorrhage, Stroke, Ischemic, TIA
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 6,000 participants (estimated)
- Lead sponsor
- University Hospital, AkershusUniversity, hospital or other
- Collaborators
- University of Oslo, Oslo University Hospital
- Study start
- 1 Jan 2012 (actual)
- Primary completion
- 31 Dec 2025 (estimated)
- Study completion
- 31 Dec 2040 (estimated)
- First posted
- 18 May 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Aims
- 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).
Study design
- Observational model
- Cohort
- Time perspective
- Other
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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)
Key inclusion criteria (1 listed)
- Cerebrovascular diseases (acute ischemic stroke, intracerebral hemorrhage, transient ischemic attack) or stroke mimics
Key exclusion criteria (1 listed)
- None
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Large vessel occlusion in a representative Norwegian population
Time frame: Baseline 2015-2017
Incidence of large vessel occlusion 2015-2017
Functional status
Time frame: 3 months
modified Rankin Scale (mRS) 0-6 (0 normal, 6 dead) for all groups
Functional status
Time frame: Index discharge from hospital, usually up to 1 month
modified Rankin Scale (mRS) 0-6 (0 normal, 6 dead) for all groups
Mortality
Time frame: In-hospital, usually up to 1 month
Number dead vs total number of cases all groups
Mortality
Time frame: 3 months
Number dead vs total number of cases all groups
Mortality
Time frame: 12 months
Number dead vs total number of cases all groups
Mortality
Time frame: 24 months
Number dead vs total number of cases all groups
Mortality
Time frame: 5 years
Number dead vs total number of cases all groups
Diagnostic precision of different published clinical screening scales of stroke and large vessel occlusion
Time frame: Baseline 2015-2017
Diagnostic precision, accuracy and validity of clinical screening scales
22 secondary outcomes
Reasons for not giving thrombolysis in patients with acute stroke symptoms < 4.5 hours
Time frame: Baseline 2015-2017
Functional outcome of patients in the stroke fast track treated or not treated with thrombolysis (or endovascular thrombectomy),
Time frame: 3 months
Mortality of patients in the stroke fast track treated or not treated with thrombolysis (or endovascular thrombectomy),
Time frame: 3 months
Functional outcome after 1 year of patients in the stroke fast track treated or not treated with thrombolysis (or endovascular thrombectomy),
Time frame: 1 year
Mortality after 1 year of patients in the stroke fast track treated or not treated with thrombolysis (or endovascular thrombectomy),
Time frame: 1 year
Functional outcome at discharge of patients in the stroke fast track treated or not treated with thrombolysis (or endovascular thrombectomy),
Time frame: Discharge after index admission, usually up to 1 month
Mortality at discharge of patients in the stroke fast track treated or not treated with thrombolysis (or endovascular thrombectomy),
Time frame: Discharge after index admission, usually up to 1 month
Re-admission
Time frame: Baseline to five years
New prescriptions
Time frame: Baseline to five years
Use of anti-coagulation in the long-term
Time frame: Baseline to five years
Use of anti-platelet therapy in the long-term
Time frame: Baseline to five years
Use of cholesterol-lowering drugs in the long-term
Time frame: Baseline to five years
Use of anti-hypertensive drugs in the long-term
Time frame: Baseline to five years
Use of anti-diabetics in the long-term
Time frame: Baseline to five years
Health care utilisation
Time frame: Baseline to five years
Prehospital delay
Time frame: 2012-2025
Time of stroke fast track
Time frame: 2012-2025
Use of stroke fast track
Time frame: 2012-2025
Treated in the stroke fast track
Time frame: 2012-2025
Blood pressure variability baseline (diastolic, systolic and pulse pressure)
Time frame: Baseline
Blood pressure variability discharge after index (diastolic, systolic and pulse pressure)
Time frame: Discharge after index admission, usually up to 1 month
Blood pressure variability follow-up (diastolic, systolic and pulse pressure)
Time frame: Follow-up (3 to 6 months)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Feb 2025.
- Results publication: PubMed 35445395Bergh 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.
- Results publication: PubMed 36252098Larsen 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.
- Results publication: PubMed 36870965Larsen 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.
- Results publication: PubMed 36807495Meinel 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.
- Results publication: PubMed 37840934MacIntosh 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.
- Derived from this study: PubMed 42406909Jahr SH, Koubaa N, Hillestad V, Larsen KT, Selseth MN, Lied-Herland T, Sundseth J, Sandset EC, Ronning OM, Kristoffersen ES. Incidence, clinical characteristics and outcome of spontaneous cerebellar intracerebral haemorrhage in a Norwegian population. Eur Stroke J. 2026 Jul 6;11(7):aakag073. doi: 10.1093/esj/aakag073.
- Derived from this study: PubMed 42319233Jahr SH, Selseth MN, Larsen KT, Sabine Reichenbach A, Altmann M, Sundseth A, Hillestad V, Bugge HF, Braarud AC, Hov MR, Faiz KW, Ronning OM, Sandset EC, Kristoffersen ES. Diagnostic performance of prehospital large-vessel occlusion detection scales in patients with suspected acute stroke: a retrospective validation study. The Akershus Study of Ischemic Stroke and Thrombolysis. Eur Stroke J. 2026 Jun 2;11(6):aakag067. doi: 10.1093/esj/aakag067.
- Individual participant dataSharing planned: Undecided. Could be possible, but must be approved by Medical Ethics Committee in Norway
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Espen S. Kristoffersen, MD, PhD contact
Espen S. Kristoffersen, MD, PhD principal investigator
University Hospital, Akershus
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Stroke, Acute and Intracerebral Hemorrhage, run by University Hospital, Akershus at 1 site in Norway.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 5 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Norway. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Espen S. Kristoffersen, MD, PhD (e.s.kristoffersen@medisin.uio.no), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Large vessel occlusion in a representative Norwegian population (time frame: Baseline 2015-2017). The study lists 9 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05378490, which also lists 7 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Feb 2025.