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

Stroke Clinical Trial

Official title:

MIDNOR-STROKE A Prospective Observation Study of a Cohort of 800 Patients With First Ever Ischemic Stroke in Central Norway

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03962127
• Other study ID #: 2015/453
• Status: Active, not recruiting
• Start date: May 1, 2015
• Est. completion date: August 2026

Study information

• Verified date: July 2023
• Source: Norwegian University of Science and Technology
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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. 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.

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

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 800
• Est. completion date: August 2026
• Est. primary completion date: August 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 90 Years

Eligibility

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).

Related Conditions & MeSH terms

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

Intervention

Other:
• no intervention
no intervention

Locations

Country	Name	City	State
Norway	Ålesund Sykehus	Ålesund
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

Sponsors (3)

Lead Sponsor	Collaborator
Norwegian University of Science and Technology	Helse Midt-Norge, St. Olavs Hospital

Country where clinical trial is conducted

Norway, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	Mortality after first ischemic stroke	Measured with data from Norwegian Death Registry	3 months
Primary	Mortality after first ischemic stroke	Measured with data from Norwegian Death Registry	1 year
Primary	Mortality after first ischemic stroke	Measured with data from Norwegian Death Registry	3 years
Primary	Mortality after first ischemic stroke	Measured with data from Norwegian Death Registry	5 years
Primary	Mortality after first ischemic stroke	Measured with data from Norwegian Death Registry	10 years
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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	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
Secondary	Proportion of patients reaching secondary prevention targets	Blood samples and questionnaire	3 months, 1, 3, 5 and 10 years