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

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Pathologic Processes; Cardiovascular Diseases; Vascular Diseases; Stroke; Cerebrovascular Disorders; Nervous System Diseases; Brain Ischemia; Cardiovascular Risk Factor; Central Nervous System Lymphoma
• Intervention / Treatment: 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 Type: Observational
• Enrollment (Actual): 800

Contacts and Locations

Study Locations

• Norway
  • Kristiansund, Norway
    • Kristiansund Sykehus
  • Levanger, Norway
    • Levanger sykehus
  • Molde, Norway
    • Molde Sykehus
  • Namsos, Norway
    • Namsos Sykehus
  • Orkanger, Norway
    • Orkdal Sykehus
  • Trondheim, Norway
    • St Olavs Hospital
  • Volda, Norway
    • Volda Sykehus
  • Ålesund, Norway
    • Ålesund sykehus

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 90 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

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

Description

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).

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	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	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	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	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	10 years
Mortality after first ischemic stroke	Measured with data from Norwegian Death Registry	3 months
Mortality after first ischemic stroke	Measured with data from Norwegian Death Registry	1 year
Mortality after first ischemic stroke	Measured with data from Norwegian Death Registry	3 years
Mortality after first ischemic stroke	Measured with data from Norwegian Death Registry	5 years
Mortality after first ischemic stroke	Measured with data from Norwegian Death Registry	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)	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)	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)	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)	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)	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)	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)	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)	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)	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)	10 years after stroke

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Cost-benefit analysis	Economic analysis that compares the costs of admission to hospital versus outpatient assessment of patients who have had transient ischemic attacks	1, 5 and 10 years
Proportion of patients reaching secondary prevention targets	Blood samples and questionnaire	3 months, 1, 3, 5 and 10 years

Collaborators and Investigators

• 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

Study record dates

Study Major Dates

• Study Start (Actual): May 1, 2015
• Primary Completion (Estimated): August 1, 2026
• Study Completion (Estimated): August 1, 2026

Study Registration Dates

• First Submitted: May 17, 2019
• First Submitted That Met QC Criteria: May 22, 2019
• First Posted (Actual): May 23, 2019

Study Record Updates

• Last Update Posted (Actual): July 21, 2023
• Last Update Submitted That Met QC Criteria: July 20, 2023
• Last Verified: July 1, 2023

More Information

Terms related to this study

• Keywords: Mortality; Risk Assessment; Health-related quality of life; NIHSS; Cardiovascular risk factors; Severity of Illness Index; Recurrent stroke; modified Rankin scale; Fatigue severity score; Hospital anxiety and depression scale; Montreal cognitive assessment
• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Stroke; Cardiovascular Diseases; Vascular Diseases; Ischemic Stroke; Brain Ischemia; Nervous System Diseases; Cerebrovascular Disorders; Pathologic Processes
• Other Study ID Numbers: 2015/453

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No