StrokeNCT03962127
MIDNOR-STROKE- a Long Term Follow-up Study of Patients With First Ever Ischemic Stroke in Central Norway
An observational study of Stroke and Cardiovascular Diseases, run by Norwegian University of Science and Technology at 8 sites in Norway.
Trial summary
Annually 13000 Norwegians experience an ischemic stroke. The number of stroke is anticipated to increase with 50% within 2030 due to a growing number of elderly. Many of them will have severe function deficits and reduced quality of life. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Stroke, Cardiovascular Diseases, Cardiovascular Risk Factor
- How many people
- 800 participants
- Where
- 8 sitesNorway
- Study dates
- 1 May 2015to Aug 2026
- 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 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients treated in a hospital in Central Norway for first time ischemic stroke.
Who may be able to join
- Cerebral infarction according to ICD-10 CM code I63
- > 18 years of age
- First time stroke resident in Central-Norway
- Recruited within a time frame of 7 days of hospital admission.
Who cannot join
- Focal neurological symptoms turned out to be not stroke-related
- Significant physical disabilities prior to stroke (defined as Modified Rankin ≥5).
Trial locations and contacts
8 sites in 1 country.
8 sites in 1 country
Norway8 sites
Ålesund Sykehus
Ålesund
Kristiansund Sykehus
Kristiansund
Levanger Sykehus
Levanger
Molde Sykehus
Molde
Namsos Sykehus
Namsos
Orkdal Sykehus
Orkanger
St Olavs Hospital
Trondheim
Volda Sykehus
Volda
About this study
Official title: MIDNOR-STROKE A Prospective Observation Study of a Cohort of 800 Patients With First Ever Ischemic Stroke in Central Norway
Annually 13000 Norwegians experience an ischemic stroke. The number of stroke is anticipated to increase with 50% within 2030 due to a growing number of elderly. Many of them will have severe function deficits and reduced quality of life. The investigators have established a cohort consisting of 800 patients with first time ischemic stroke treated at hospitals in Central Norway. The investigators want to study the incidence and prognostic markers for death, recurrent stroke and severe functional deficits during a period of 10 years after the initial ischemic stroke. The investigators want to focus on the impact of physical functioning, the level of physical activity and use of medication for secondary prevention on the incidence of death, recurrent stroke and severe functional deficits. The investigators are especially interested in the importance of fulfilling the treatment targets for blood pressure and cholesterol and the importance of smoking cessation in stroke survivors. Our objective is to improve todays stroke treatment and achieve a more efficient use of the health resources in order to increase survival after stroke maintaining a good physical and psychological function and quality of life.
Read the detailed description
MIDNOR STROKE is a descriptive prospective longitudinal cohort study, which includes patients with a first event of ischemic stroke admitted to hospitals in Central Norway. The overall objective of this study is to complete a 10-year follow-up of patients with ischemic stroke.
Patient recruitment started 01.09.2015 and ended 01.11.2017. During this time-period, a total of 802 patients were recruited. Patient follow-up at 3 months is completed and follow-up at 12 months will be completed 01.11.18.
All participants met the following inclusion criteria; cerebral infarction according to ICD-10 CM code I63, > 18 years of age, first time stroke, resident in Central-Norway and recruited within a timeframe of 7 days of hospital admission. Patients were excluded if focal neurological symptoms turned out to be not stroke-related or if there were significant physical disabilities prior to stroke (defined as Modified Rankin ≥5)
Eligible stroke patients were recruited during acute stay in hospital. Written informed consent was obtained from all potential stroke patients and from their legal caretakers (mostly a close family member), admitted to the hospital and each subject signed an informed consent form. All participants were examined and treated in line with The Recommended Guidelines for treatment and rehabilitation of stroke, which includes clinical examinations, blood tests, assessment of risk profile and additional relevant examinations.
Stroke patients were recruited and patient data collected by a designated nurse during the initial stay at the hospital. Either a nurse or research assistant in the project performed patient follow-up at 3 and 12 months. Data collected at 3 months included data from a clinical and physical assessment, interview, questionnaires and medical records. Follow-up data at 12 months is collected by phone interview and questionnaires.
The data have been collected at baseline, 3 - and 12 months. Further data collection is planned at 3, 5 and 10 years.
The comprehensive data collection in MIDNOR STROKE at baseline includes data on pre-stroke function (Barthel index, Nottingham ADL, Modified rankin scale), life style risk factors, stroke severity (NIHSS, SSS, TOAST classifications), previous disease, vital signs (i.e. blood pressure, pulse, oxygen saturation), blood values, complications during hospital stay, medication and medical images during hospital stay. Assessment at 3 months included information on physical function, physical activity (HUNT - International physical activity questionnaire), cognitive function (Montreal cognitive assessment), depression (Hospital and anxiety and depression scale), fatigue (Fatigue severity score) and health related quality of life (EQ- 5D- 5L). Data collection at 12 months includes data on physical function, medication, depression, fatigue and health related quality of life.
Additional data will be collected from the Norwegian Stroke Registry, The Norwegian Patient registry, The Norwegian cardiovascular disease registry and The Norwegian Cause of Death registry.
The overall aim for MIDNOR STROKE is to establish a cohort of patients with first- time stroke to study the occurrence and predictors for recurrent stroke, mortality, physical activity, disability and the quality of life during a 10-year period.
MIDNOR STROKE contains six work packages, which address the key areas of interest in the project:
- Recurrent stroke, mortality, disability and quality of life after stroke
- Secondary prevention of stroke in relation to recurrent stroke, mortality, disability and quality of life.
- Physical activity and function among stroke patients
- Prediction models for recurrent stroke, disability and quality of life after stroke
- Pathophysiologic mechanisms of acute ischemic stroke
- Stroke health economics, health care resources cost and use
- Conditions
- Stroke, Cardiovascular Diseases, Cardiovascular Risk Factor, Brain Ischemia, Cerebrovascular Disorders, Nervous System Diseases
- Being tested
- no intervention
- Keywords
- Cardiovascular risk factors, Risk Assessment, Severity of Illness Index, Mortality, Recurrent stroke, Health-related quality of life, modified Rankin scale, NIHSS, Fatigue severity score, Hospital anxiety and depression scale, Montreal cognitive assessment
- Medical subject headings
- Stroke, Cardiovascular Diseases, Brain Ischemia, Cerebrovascular Disorders, Nervous System Diseases, Pathologic Processes, Vascular Diseases, Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
no interventionOther
no intervention
| Study group | Role | What they receive |
|---|---|---|
| First time ischemic stroke | Patients with a first event of ischemic stroke admitted to hospitals in Central Norway. Receives: Other: no intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
The incidence of recurrent stroke after first ever ischemic stroke
Measured by using data from the Norwegian Stroke Registry and other Norwegian Cardiovascular registries including patient questionnaires
Measured: 3 months
The incidence of recurrent stroke after first ever ischemic stroke
Measured by using data from the Norwegian Stroke Registry and other Norwegian Cardiovascular registries including patient questionnaires
Measured: 1 year
The incidence of recurrent stroke after first ever ischemic stroke
Measured by using data from the Norwegian Stroke Registry and other Norwegian Cardiovascular registries including patient questionnaires
Measured: 3 years
The incidence of recurrent stroke after first ever ischemic stroke
Measured by using data from the Norwegian Stroke Registry and other Norwegian Cardiovascular registries including patient questionnaires
Measured: 5 years
The incidence of recurrent stroke after first ever ischemic stroke
Measured by using data from the Norwegian Stroke Registry and other Norwegian Cardiovascular registries including patient questionnaires
Measured: 10 years
Mortality after first ischemic stroke
Measured with data from Norwegian Death Registry
Measured: 3 months
Mortality after first ischemic stroke
Measured with data from Norwegian Death Registry
Measured: 1 year
Mortality after first ischemic stroke
Measured with data from Norwegian Death Registry
Measured: 3 years
Mortality after first ischemic stroke
Measured with data from Norwegian Death Registry
Measured: 5 years
Mortality after first ischemic stroke
Measured with data from Norwegian Death Registry
Measured: 10 years
Functional disability after stroke
Modified rankin scale 3 - 5 (the degree of disability, total range 0 - 6, value above 2 represents a worse outcome)
Measured: 3 months after stroke
Functional disability after stroke
Modified rankin scale 3 - 5 (the degree of disability, total range 0 - 6,value above 2 represents a worse outcome)
Measured: 1 year after stroke
Functional disability after stroke
Modified rankin scale 3 - 5 (the degree of disability, total range 0 - 6, value above 2 represents a worse outcome)
Measured: 3 years after stroke
Functional disability after stroke
Modified rankin scale 3 - 5 (the degree of disability, total range 0 - 6, value above 2 represents a worse outcome)
Measured: 5 years after stroke
Functional disability after stroke
Modified rankin scale 3 - 5 (the degree of disability, total range 0 - 6, value above 2 represents a worse outcome)
Measured: 10 years after stroke
Health-related quality of life after stroke
EQ-5D-5L (5 Levels from 1-5 in 5 categories where values above 2 represents reduced life quality)
Measured: 3 months after stroke
Health-related quality of life after stroke
EQ-5D-5L(5 Levels from 1-5 in 5 categories where values above 1 represents reduced life quality)
Measured: 1 year after stroke
Health-related quality of life after stroke
EQ-5D-5L(5 Levels from 1-5 in 5 categories where values above 1 represents reduced life quality)
Measured: 3 years after stroke
Health-related quality of life after stroke
EQ-5D-5L (5 Levels from 1-5 in 5 categories where values above 1 represents reduced life quality)
Measured: 5 years after stroke
Health-related quality of life after stroke
EQ-5D-5L (5 Levels from 1-5 in 5 categories where values above 1 represents reduced life quality)
Measured: 10 years after stroke
Secondary outcomes (2)
Cost-benefit analysis
Economic analysis that compares the costs of admission to hospital versus outpatient assessment of patients who have had transient ischemic attacks
Measured: 1, 5 and 10 years
Proportion of patients reaching secondary prevention targets
Blood samples and questionnaire
Measured: 3 months, 1, 3, 5 and 10 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 May 2019
- Study start1 May 2015
- Primary completionAug 2026 (estimated)
- Study completionAug 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for StrokeStudies of the same condition, open and under way.
- More trials run by Norwegian University of Science and TechnologyThe sponsor's other registered studies.
- 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
- Prospective
- Enrolment
- 800 participants (actual)
Sponsor and investigators
- Lead sponsor
- Norwegian University of Science and Technology
- Sponsor type
- University, hospital or other
- Collaborators
- St. Olavs Hospital, Helse Midt-Norge
- Responsible party
- Sponsor
- Investigators
- Bent Indredavik, PhD Prof, Study director, Norwegian University of Science and Technology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03962127
- Sponsor's protocol ID
- 2015/453
- Status last verified
- Aug 2026
- First submitted
- 17 May 2019
- Last updated
- 13 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- MIDNOR-STROKE A Prospective Observation Study of a Cohort of 800 Patients With First Ever Ischemic Stroke in Central Norway
- ClinicalTrials.gov ID
- NCT03962127
- Acronym / sponsor ID
- 2015/453
- Conditions
- Stroke, Cardiovascular Diseases, Cardiovascular Risk Factor, Brain Ischemia, Cerebrovascular Disorders, Nervous System Diseases
- Keywords
- Cardiovascular risk factors, Risk Assessment, Severity of Illness Index, Mortality, Recurrent stroke, Health-related quality of life, modified Rankin scale, NIHSS
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 800 participants (actual)
- Lead sponsor
- Norwegian University of Science and TechnologyUniversity, hospital or other
- Collaborators
- St. Olavs Hospital, Helse Midt-Norge
- Study start
- 1 May 2015 (actual)
- Primary completion
- Aug 2026 (estimated)
- Study completion
- Aug 2026 (estimated)
- First posted
- 23 May 2019 (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.
Annually 13000 Norwegians experience an ischemic stroke. The number of stroke is anticipated to increase with 50% within 2030 due to a growing number of elderly. Many of them will have severe function deficits and reduced quality of life. The investigators have established a cohort consisting of 800 patients with first time ischemic stroke treated at hospitals in Central Norway. The investigators want to study the incidence and prognostic markers for death, recurrent stroke and severe functional deficits during a period of 10 years after the initial ischemic stroke. The investigators want to focus on the impact of physical functioning, the level of physical activity and use of medication for secondary prevention on the incidence of death, recurrent stroke and severe functional deficits. The investigators are especially interested in the importance of fulfilling the treatment targets for blood pressure and cholesterol and the importance of smoking cessation in stroke survivors. Our objective is to improve todays stroke treatment and achieve a more efficient use of the health resources in order to increase survival after stroke maintaining a good physical and psychological function and quality of life.
Detailed description
MIDNOR STROKE is a descriptive prospective longitudinal cohort study, which includes patients with a first event of ischemic stroke admitted to hospitals in Central Norway. The overall objective of this study is to complete a 10-year follow-up of patients with ischemic stroke.
Patient recruitment started 01.09.2015 and ended 01.11.2017. During this time-period, a total of 802 patients were recruited. Patient follow-up at 3 months is completed and follow-up at 12 months will be completed 01.11.18.
All participants met the following inclusion criteria; cerebral infarction according to ICD-10 CM code I63, > 18 years of age, first time stroke, resident in Central-Norway and recruited within a timeframe of 7 days of hospital admission. Patients were excluded if focal neurological symptoms turned out to be not stroke-related or if there were significant physical disabilities prior to stroke (defined as Modified Rankin ≥5)
Eligible stroke patients were recruited during acute stay in hospital. Written informed consent was obtained from all potential stroke patients and from their legal caretakers (mostly a close family member), admitted to the hospital and each subject signed an informed consent form. All participants were examined and treated in line with The Recommended Guidelines for treatment and rehabilitation of stroke, which includes clinical examinations, blood tests, assessment of risk profile and additional relevant examinations.
Stroke patients were recruited and patient data collected by a designated nurse during the initial stay at the hospital. Either a nurse or research assistant in the project performed patient follow-up at 3 and 12 months. Data collected at 3 months included data from a clinical and physical assessment, interview, questionnaires and medical records. Follow-up data at 12 months is collected by phone interview and questionnaires.
The data have been collected at baseline, 3 - and 12 months. Further data collection is planned at 3, 5 and 10 years.
The comprehensive data collection in MIDNOR STROKE at baseline includes data on pre-stroke function (Barthel index, Nottingham ADL, Modified rankin scale), life style risk factors, stroke severity (NIHSS, SSS, TOAST classifications), previous disease, vital signs (i.e. blood pressure, pulse, oxygen saturation), blood values, complications during hospital stay, medication and medical images during hospital stay. Assessment at 3 months included information on physical function, physical activity (HUNT - International physical activity questionnaire), cognitive function (Montreal cognitive assessment), depression (Hospital and anxiety and depression scale), fatigue (Fatigue severity score) and health related quality of life (EQ- 5D- 5L). Data collection at 12 months includes data on physical function, medication, depression, fatigue and health related quality of life.
Additional data will be collected from the Norwegian Stroke Registry, The Norwegian Patient registry, The Norwegian cardiovascular disease registry and The Norwegian Cause of Death registry.
The overall aim for MIDNOR STROKE is to establish a cohort of patients with first- time stroke to study the occurrence and predictors for recurrent stroke, mortality, physical activity, disability and the quality of life during a 10-year period.
MIDNOR STROKE contains six work packages, which address the key areas of interest in the project:
- Recurrent stroke, mortality, disability and quality of life after stroke
- Secondary prevention of stroke in relation to recurrent stroke, mortality, disability and quality of life.
- Physical activity and function among stroke patients
- Prediction models for recurrent stroke, disability and quality of life after stroke
- Pathophysiologic mechanisms of acute ischemic stroke
- Stroke health economics, health care resources cost and use
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| First time ischemic stroke | – | Other: no interventionPatients with a first event of ischemic stroke admitted to hospitals in Central Norway. |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients treated in a hospital in Central Norway for first time ischemic stroke.
Key inclusion criteria (4 listed)
- Cerebral infarction according to ICD-10 CM code I63
- > 18 years of age
- First time stroke resident in Central-Norway
- Recruited within a time frame of 7 days of hospital admission.
Key exclusion criteria (2 listed)
- Focal neurological symptoms turned out to be not stroke-related
- Significant physical disabilities prior to stroke (defined as Modified Rankin ≥5).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| no interventionno intervention | Other | First time ischemic stroke |
Primary outcome
The incidence of recurrent stroke after first ever ischemic stroke
Time frame: 3 months
Measured by using data from the Norwegian Stroke Registry and other Norwegian Cardiovascular registries including patient questionnaires
The incidence of recurrent stroke after first ever ischemic stroke
Time frame: 1 year
Measured by using data from the Norwegian Stroke Registry and other Norwegian Cardiovascular registries including patient questionnaires
The incidence of recurrent stroke after first ever ischemic stroke
Time frame: 3 years
Measured by using data from the Norwegian Stroke Registry and other Norwegian Cardiovascular registries including patient questionnaires
The incidence of recurrent stroke after first ever ischemic stroke
Time frame: 5 years
Measured by using data from the Norwegian Stroke Registry and other Norwegian Cardiovascular registries including patient questionnaires
The incidence of recurrent stroke after first ever ischemic stroke
Time frame: 10 years
Measured by using data from the Norwegian Stroke Registry and other Norwegian Cardiovascular registries including patient questionnaires
Mortality after first ischemic stroke
Time frame: 3 months
Measured with data from Norwegian Death Registry
Mortality after first ischemic stroke
Time frame: 1 year
Measured with data from Norwegian Death Registry
Mortality after first ischemic stroke
Time frame: 3 years
Measured with data from Norwegian Death Registry
Mortality after first ischemic stroke
Time frame: 5 years
Measured with data from Norwegian Death Registry
Mortality after first ischemic stroke
Time frame: 10 years
Measured with data from Norwegian Death Registry
Functional disability after stroke
Time frame: 3 months after stroke
Modified rankin scale 3 - 5 (the degree of disability, total range 0 - 6, value above 2 represents a worse outcome)
Functional disability after stroke
Time frame: 1 year after stroke
Modified rankin scale 3 - 5 (the degree of disability, total range 0 - 6,value above 2 represents a worse outcome)
Functional disability after stroke
Time frame: 3 years after stroke
Modified rankin scale 3 - 5 (the degree of disability, total range 0 - 6, value above 2 represents a worse outcome)
Functional disability after stroke
Time frame: 5 years after stroke
Modified rankin scale 3 - 5 (the degree of disability, total range 0 - 6, value above 2 represents a worse outcome)
Functional disability after stroke
Time frame: 10 years after stroke
Modified rankin scale 3 - 5 (the degree of disability, total range 0 - 6, value above 2 represents a worse outcome)
Health-related quality of life after stroke
Time frame: 3 months after stroke
EQ-5D-5L (5 Levels from 1-5 in 5 categories where values above 2 represents reduced life quality)
Health-related quality of life after stroke
Time frame: 1 year after stroke
EQ-5D-5L(5 Levels from 1-5 in 5 categories where values above 1 represents reduced life quality)
Health-related quality of life after stroke
Time frame: 3 years after stroke
EQ-5D-5L(5 Levels from 1-5 in 5 categories where values above 1 represents reduced life quality)
Health-related quality of life after stroke
Time frame: 5 years after stroke
EQ-5D-5L (5 Levels from 1-5 in 5 categories where values above 1 represents reduced life quality)
Health-related quality of life after stroke
Time frame: 10 years after stroke
EQ-5D-5L (5 Levels from 1-5 in 5 categories where values above 1 represents reduced life quality)
2 secondary outcomes
Cost-benefit analysis
Time frame: 1, 5 and 10 years
Proportion of patients reaching secondary prevention targets
Time frame: 3 months, 1, 3, 5 and 10 years
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 13 Aug 2026.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
Bent Indredavik, PhD Prof study director
Norwegian University of Science and Technology
8 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Stroke and Cardiovascular Diseases, run by Norwegian University of Science and Technology at 8 sites 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 4 inclusion and 2 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: under way, not looking for participants, as of the sponsor's last update on 13 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The incidence of recurrent stroke after first ever ischemic stroke (time frame: 3 months). The study lists 20 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 13 Aug 2026.