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

• ClinicalTrials.gov Identifier: NCT03962127
• Recruitment Status: Active, not recruiting
• First Posted: May 23, 2019
• Last Update Posted: July 21, 2023
• Sponsor: Norwegian University of Science and Technology
• Collaborators: St. Olavs Hospital; Helse Midt-Norge
• Information provided by (Responsible Party): Norwegian University of Science and Technology

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

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 Design

• 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

Groups and Cohorts

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

• 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

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

• Study Director: Bent Indredavik, PhD Prof; Norwegian University of Science and Technology

More Information

• Responsible Party: Norwegian University of Science and Technology
• ClinicalTrials.gov Identifier: NCT03962127
• Other Study ID Numbers: 2015/453
• First Posted: May 23, 2019
• Last Update Posted: July 21, 2023
• Last Verified: July 2023

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Norwegian University of Science and Technology:

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

Additional relevant MeSH terms:

Stroke; Ischemic Stroke; Nervous System Diseases; Cerebrovascular Disorders; Brain Ischemia; Cardiovascular Diseases; Vascular Diseases; Pathologic Processes; Brain Diseases; Central Nervous System Diseases