Skip to main content
OpenTrials
Recruiting

NCT Number: NCT05378490

The Akershus Study of Ischemic Stroke and Thrombolysis -1

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.

Recruiting

Interested in participating?

Request Info

Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Akershus University Hospital

Lørenskog, 1478, Norway

Location status: Recruiting

Location contact

Espen S. Kristoffersen, MD, PhD

CONTACT

[email protected]

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • None

Treatment and study plan

Primary outcomes

  1. Large vessel occlusion in a representative Norwegian population

    Time frame: Baseline 2015-2017

    Incidence of large vessel occlusion 2015-2017

  2. Functional status

    Time frame: 3 months

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

  3. 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

  4. Mortality

    Time frame: In-hospital, usually up to 1 month

    Number dead vs total number of cases all groups

  5. Mortality

    Time frame: 3 months

    Number dead vs total number of cases all groups

  6. Mortality

    Time frame: 12 months

    Number dead vs total number of cases all groups

  7. Mortality

    Time frame: 24 months

    Number dead vs total number of cases all groups

  8. Mortality

    Time frame: 5 years

    Number dead vs total number of cases all groups

  9. 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

Secondary outcomes

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

    Time frame: Baseline 2015-2017

    Number of cases treated with thrombolysis vs number of cases evaluated in the acute stroke care pathway

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

    Time frame: 3 months

    Modified Rankin Scale (mRS) 0-6 (0 normal, 6 dead)

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

    Time frame: 3 months

    Mortality

  4. 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

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

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

    Time frame: 1 year

    Mortality

  6. 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

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

  7. 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

    Mortality

  8. Re-admission

    Time frame: Baseline to five years

    Number of new re-admission among included patients

  9. New prescriptions

    Time frame: Baseline to five years

    Type of new prescriptions

  10. Use of anti-coagulation in the long-term

    Time frame: Baseline to five years

    Number of patients treated with anti-coagulation

  11. Use of anti-platelet therapy in the long-term

    Time frame: Baseline to five years

    Number of patients treated with anti-platelet therapy

  12. Use of cholesterol-lowering drugs in the long-term

    Time frame: Baseline to five years

    Number of patients treated with cholesterol-lowering drugs

  13. Use of anti-hypertensive drugs in the long-term

    Time frame: Baseline to five years

    Number of patients treated with anti-hypertensive drugs

  14. Use of anti-diabetics in the long-term

    Time frame: Baseline to five years

    Number of patients treated with anti-diabetics

  15. Health care utilisation

    Time frame: Baseline to five years

    Number of new health care system contacts

  16. Prehospital delay

    Time frame: 2012-2025

    Changes in prehospital delay (minutes)

  17. Time of stroke fast track

    Time frame: 2012-2025

    Changes in the use of stroke fast track (minutes)

  18. Use of stroke fast track

    Time frame: 2012-2025

    Changes in the use of stroke pathways (proportion)

  19. Treated in the stroke fast track

    Time frame: 2012-2025

    Changes in proportion treated over time

  20. Blood pressure variability baseline (diastolic, systolic and pulse pressure)

    Time frame: Baseline

    Different BP measurements from general practitioners, ambulance, hospital and follow-up

  21. Blood pressure variability discharge after index (diastolic, systolic and pulse pressure)

    Time frame: Discharge after index admission, usually up to 1 month

    Different BP measurements from general practitioners, ambulance, hospital and follow-up

  22. Blood pressure variability follow-up (diastolic, systolic and pulse pressure)

    Time frame: Follow-up (3 to 6 months)

    Different BP measurements from general practitioners, ambulance, hospital and follow-up

Study contacts

Contact information is provided by the study sponsor or research team.

Espen S. Kristoffersen, MD, PhD

CONTACT

[email protected]

Sponsors and collaborators

Lead sponsor

University Hospital, Akershus

Other

Collaborators

  • Oslo University Hospital
  • University of Oslo

Registry information

Official study 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

Acronym: ASIST-1

Important dates

Study start
2012
Primary completion
2025
Study completion
2040
First posted
May 18, 2022
Registry last updated
Feb 5, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.