Clinical trial NCT03962127: 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
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: 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
Lead sponsor: Norwegian University of Science and Technology
Sponsor class: OTHER
Collaborators: name: St. Olavs Hospital
name: Helse Midt-Norge
First posted: 2019-05-23
Enrollment: 800
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients treated in a hospital in Central Norway for first time ischemic stroke.

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

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).

Primary outcomes:
measure: The incidence of recurrent stroke after first ever ischemic stroke
timeFrame: 3 months
measure: The incidence of recurrent stroke after first ever ischemic stroke
timeFrame: 1 year
measure: The incidence of recurrent stroke after first ever ischemic stroke
timeFrame: 3 years
measure: The incidence of recurrent stroke after first ever ischemic stroke
timeFrame: 5 years
measure: The incidence of recurrent stroke after first ever ischemic stroke
timeFrame: 10 years
measure: Mortality after first ischemic stroke
timeFrame: 3 months
measure: Mortality after first ischemic stroke
timeFrame: 1 year
measure: Mortality after first ischemic stroke
timeFrame: 3 years
measure: Mortality after first ischemic stroke
timeFrame: 5 years
measure: Mortality after first ischemic stroke
timeFrame: 10 years
measure: Functional disability after stroke
timeFrame: 3 months after stroke
measure: Functional disability after stroke
timeFrame: 1 year after stroke
measure: Functional disability after stroke
timeFrame: 3 years after stroke
measure: Functional disability after stroke
timeFrame: 5 years after stroke
measure: Functional disability after stroke
timeFrame: 10 years after stroke
measure: Health-related quality of life after stroke
timeFrame: 3 months after stroke
measure: Health-related quality of life after stroke
timeFrame: 1 year after stroke
measure: Health-related quality of life after stroke
timeFrame: 3 years after stroke
measure: Health-related quality of life after stroke
timeFrame: 5 years after stroke
measure: Health-related quality of life after stroke
timeFrame: 10 years after stroke
Secondary outcomes:
measure: Cost-benefit analysis
timeFrame: 1, 5 and 10 years
measure: Proportion of patients reaching secondary prevention targets
timeFrame: 3 months, 1, 3, 5 and 10 years
Other outcomes:
Locations:
city: Kristiansund
country: Norway
facility: Kristiansund Sykehus
city: Levanger
country: Norway
facility: Levanger Sykehus
city: Molde
country: Norway
facility: Molde Sykehus
city: Namsos
country: Norway
facility: Namsos Sykehus
city: Orkanger
country: Norway
facility: Orkdal Sykehus
city: Trondheim
country: Norway
facility: St Olavs Hospital
city: Volda
country: Norway
facility: Volda Sykehus
city: Ålesund
country: Norway
facility: Ålesund Sykehus
Study officials:
affiliation: Norwegian University of Science and Technology
name: Bent Indredavik, PhD Prof
role: STUDY_DIRECTOR
References: