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出境医 / 临床实验 / MIDNOR-STROKE- a Long Term Follow-up Study of Patients With First Ever Ischemic Stroke in Central Norway

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

Study Description
Brief 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.

Condition or disease Intervention/treatment
Stroke Cardiovascular Diseases Cardiovascular Risk Factor Brain Ischemia Cerebrovascular Disorders Nervous System Diseases Central Nervous System Lymphoma Pathologic Processes Vascular Diseases Other: no intervention

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Study Design
Layout table for study information
Study Type : Observational
Actual Enrollment : 800 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: MIDNOR-STROKE A Prospective Observation Study of a Cohort of 800 Patients With First Ever Ischemic Stroke in Central Norway
Actual Study Start Date : May 1, 2015
Estimated Primary Completion Date : August 2026
Estimated Study Completion Date : August 2026
Arms and Interventions
Group/Cohort Intervention/treatment
First time ischemic stroke
Patients with a first event of ischemic stroke admitted to hospitals in Central Norway.
Other: no intervention
no intervention

Outcome Measures
Primary Outcome Measures :
  1. 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

  2. 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

  3. 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

  4. 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

  5. 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

  6. Mortality after first ischemic stroke [ Time Frame: 3 months ]
    Measured with data from Norwegian Death Registry

  7. Mortality after first ischemic stroke [ Time Frame: 1 year ]
    Measured with data from Norwegian Death Registry

  8. Mortality after first ischemic stroke [ Time Frame: 3 years ]
    Measured with data from Norwegian Death Registry

  9. Mortality after first ischemic stroke [ Time Frame: 5 years ]
    Measured with data from Norwegian Death Registry

  10. Mortality after first ischemic stroke [ Time Frame: 10 years ]
    Measured with data from Norwegian Death Registry

  11. 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)

  12. 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)

  13. 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)

  14. 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)

  15. 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)

  16. 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)

  17. 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)

  18. 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)

  19. 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)

  20. 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)


Secondary Outcome Measures :
  1. Cost-benefit analysis [ Time Frame: 1, 5 and 10 years ]
    Economic analysis that compares the costs of admission to hospital versus outpatient assessment of patients who have had transient ischemic attacks

  2. Proportion of patients reaching secondary prevention targets [ Time Frame: 3 months, 1, 3, 5 and 10 years ]
    Blood samples and questionnaire


Biospecimen Retention:   None Retained
Blood samples

Eligibility Criteria
Layout table for eligibility information
Ages Eligible for Study:   18 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   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.
Criteria

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:

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

Locations
Layout table for location information
Norway
Kristiansund Sykehus
Kristiansund, Norway
Levanger Sykehus
Levanger, Norway
Molde Sykehus
Molde, Norway
Namsos Sykehus
Namsos, Norway
Orkdal Sykehus
Orkanger, Norway
St Olavs Hospital
Trondheim, Norway
Volda Sykehus
Volda, Norway
Ålesund Sykehus
Ålesund, Norway
Sponsors and Collaborators
Norwegian University of Science and Technology
St. Olavs Hospital
Helse Midt-Norge
Investigators
Layout table for investigator information
Study Director: Bent Indredavik, PhD Prof Norwegian University of Science and Technology
Tracking Information
First Submitted Date May 17, 2019
First Posted Date May 23, 2019
Last Update Posted Date May 27, 2021
Actual Study Start Date May 1, 2015
Estimated Primary Completion Date August 2026   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: May 22, 2019)
  • 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)
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures
 (submitted: May 22, 2019)
  • Cost-benefit analysis [ Time Frame: 1, 5 and 10 years ]
    Economic analysis that compares the costs of admission to hospital versus outpatient assessment of patients who have had transient ischemic attacks
  • Proportion of patients reaching secondary prevention targets [ Time Frame: 3 months, 1, 3, 5 and 10 years ]
    Blood samples and questionnaire
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title MIDNOR-STROKE- a Long Term Follow-up Study of Patients With First Ever Ischemic Stroke in Central Norway
Official Title MIDNOR-STROKE A Prospective Observation Study of a Cohort of 800 Patients With First Ever Ischemic Stroke in Central Norway
Brief 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.
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
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Retention:   None Retained
Description:
Blood samples
Sampling Method Non-Probability Sample
Study Population Patients treated in a hospital in Central Norway for first time ischemic stroke.
Condition
  • Stroke
  • Cardiovascular Diseases
  • Cardiovascular Risk Factor
  • Brain Ischemia
  • Cerebrovascular Disorders
  • Nervous System Diseases
  • Central Nervous System Lymphoma
  • Pathologic Processes
  • Vascular Diseases
Intervention Other: no intervention
no intervention
Study Groups/Cohorts First time ischemic stroke
Patients with a first event of ischemic stroke admitted to hospitals in Central Norway.
Intervention: Other: no intervention
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Active, not recruiting
Actual Enrollment
 (submitted: May 22, 2019)
800
Original Actual Enrollment Same as current
Estimated Study Completion Date August 2026
Estimated Primary Completion Date August 2026   (Final data collection date for primary outcome measure)
Eligibility Criteria

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:

  • Focal neurological symptoms turned out to be not stroke-related
  • Significant physical disabilities prior to stroke (defined as Modified Rankin ≥5).
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years to 90 Years   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Norway
Removed Location Countries  
 
Administrative Information
NCT Number NCT03962127
Other Study ID Numbers 2015/453
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement
Plan to Share IPD: No
Responsible Party Norwegian University of Science and Technology
Study Sponsor Norwegian University of Science and Technology
Collaborators
  • St. Olavs Hospital
  • Helse Midt-Norge
Investigators
Study Director: Bent Indredavik, PhD Prof Norwegian University of Science and Technology
PRS Account Norwegian University of Science and Technology
Verification Date May 2021