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Active, not recruitingNCT03962127Updated Aug 13, 2026

MIDNOR-STROKE- a Long Term Follow-up Study of Patients With First Ever Ischemic Stroke in Central Norway

An observational study in Stroke, Cardiovascular Diseases and Cardiovascular Risk Factor, sponsored by Norwegian University of Science and Technology. Active, not recruiting at 8 sites in Norway. Open to participants aged 18 Years to 90 Years. Per ClinicalTrials.gov, last updated 2026-08-13.

Sponsored by Norwegian University of Science and Technology · Observational

From the registry’s dates

  • Primary completion was expected by Aug 2026, 3 months ago, but the record still lists the study as active, not recruiting.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
800
Ages
18 Years to 90 Years
Sex
All
01

Study 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. 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:

  1. Recurrent stroke, mortality, disability and quality of life after stroke
  2. Secondary prevention of stroke in relation to recurrent stroke, mortality, disability and quality of life.
  3. Physical activity and function among stroke patients
  4. Prediction models for recurrent stroke, disability and quality of life after stroke
  5. Pathophysiologic mechanisms of acute ischemic stroke
  6. Stroke health economics, health care resources cost and use
02

Conditions studied

  • Stroke
  • Cardiovascular Diseases
  • Cardiovascular Risk Factor
  • Brain Ischemia
  • Cerebrovascular Disorders
  • Nervous System Diseases
  • Central Nervous System Lymphoma
  • Pathologic Processes
  • Vascular Diseases

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
03

In context

Stroke

8,255 studies on the registry are indexed under Stroke; 2,056 are open to participants now.

This study's enrollment of 800 is above the median of 152 across 1,968 observational studies indexed under Stroke.

Browse Stroke studies →

Lead sponsor

Norwegian University of Science and Technology is the lead sponsor of 495 studies on the registry; 48 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 90 Years
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Patients treated in a hospital in Central Norway for first time ischemic stroke.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • 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.

Exclusion criteria

Exclusion criteria:

  • Focal neurological symptoms turned out to be not stroke-related
  • Significant physical disabilities prior to stroke (defined as Modified Rankin ≥5).
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
800 participants (actual)
Patient registry
No
Biospecimen retention
None retained

Groups and cohorts

  • First time ischemic stroke

    Patients with a first event of ischemic stroke admitted to hospitals in Central Norway.

    Other: no intervention

Interventions

  • Otherno intervention

    no intervention

06

What researchers measure

Primary outcomes

  1. 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

    Time frame: 3 months

  2. 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

    Time frame: 1 year

  3. 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

    Time frame: 3 years

  4. 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

    Time frame: 5 years

  5. 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

    Time frame: 10 years

  6. Mortality after first ischemic stroke

    Measured with data from Norwegian Death Registry

    Time frame: 3 months

  7. Mortality after first ischemic stroke

    Measured with data from Norwegian Death Registry

    Time frame: 1 year

  8. Mortality after first ischemic stroke

    Measured with data from Norwegian Death Registry

    Time frame: 3 years

  9. Mortality after first ischemic stroke

    Measured with data from Norwegian Death Registry

    Time frame: 5 years

  10. Mortality after first ischemic stroke

    Measured with data from Norwegian Death Registry

    Time frame: 10 years

  11. Functional disability after stroke

    Modified rankin scale 3 - 5 (the degree of disability, total range 0 - 6, value above 2 represents a worse outcome)

    Time frame: 3 months after stroke

  12. Functional disability after stroke

    Modified rankin scale 3 - 5 (the degree of disability, total range 0 - 6,value above 2 represents a worse outcome)

    Time frame: 1 year after stroke

  13. Functional disability after stroke

    Modified rankin scale 3 - 5 (the degree of disability, total range 0 - 6, value above 2 represents a worse outcome)

    Time frame: 3 years after stroke

  14. Functional disability after stroke

    Modified rankin scale 3 - 5 (the degree of disability, total range 0 - 6, value above 2 represents a worse outcome)

    Time frame: 5 years after stroke

  15. Functional disability after stroke

    Modified rankin scale 3 - 5 (the degree of disability, total range 0 - 6, value above 2 represents a worse outcome)

    Time frame: 10 years after stroke

  16. 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)

    Time frame: 3 months after stroke

  17. 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)

    Time frame: 1 year after stroke

  18. 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)

    Time frame: 3 years after stroke

  19. 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)

    Time frame: 5 years after stroke

  20. 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)

    Time frame: 10 years after stroke

Secondary outcomes

  1. Cost-benefit analysis

    Economic analysis that compares the costs of admission to hospital versus outpatient assessment of patients who have had transient ischemic attacks

    Time frame: 1, 5 and 10 years

  2. Proportion of patients reaching secondary prevention targets

    Blood samples and questionnaire

    Time frame: 3 months, 1, 3, 5 and 10 years

07

Study locations

8 sites
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started May 2015 (actual). Primary completion is estimated for Aug 2026, 135 months after the start.

Of 835 non-industry observational studies under Stroke, half reached primary completion within 41 months of starting (the median), counting those still running; a quarter within 18 and three quarters within 92. This study's planned 135 months is above that.

Counting every sponsor, half of 897 studies reached it within 40 months; a quarter within 18 and three quarters within 85.

How these figures are worked out, and which studies are left out of them.

Registered
May 17, 2019
First posted
May 23, 2019
StartActual
May 1, 2015
Primary completionEst.
Aug 2026
CompletionEst.
Aug 2026
Last update
Aug 13, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Aug 13, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03962127
Collaborators
St. Olavs Hospital, Helse Midt-Norge
Responsible party
Sponsor
First posted
May 23, 2019
Start date
May 1, 2015
Primary completion
Aug 2026 (estimated)
Completion
Aug 2026 (estimated)
Last update
Aug 13, 2026

Study contacts

Bent Indredavik, PhD Prof
study director · Norwegian University of Science and Technology

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is active, not recruiting, as verified in Aug 2026. You cannot join it, but the record below documents what was studied.

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