Recruitment

Recruitment Status
Active, not recruiting

Summary

Conditions
  • Brain Ischemia
  • Cardiovascular Diseases
  • Cardiovascular Risk Factor
  • Central Nervous System Lymphoma
  • Cerebrovascular Disorders
  • Nervous System Diseases
  • Pathologic Processes
  • Stroke
  • Vascular Diseases
Type
Observational
Design
Observational Model: CohortTime Perspective: Prospective

Participation Requirements

Age
Between 18 years and 90 years
Gender
Both males and females

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 st...

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: Recurrent stroke, mortality, disability and quality of life after stroke Secondary prevention of stroke in relation to recurrent stroke, mortality, disability and quality of life. Physical activity and function among stroke patients Prediction models for recurrent stroke, disability and quality of life after stroke Pathophysiologic mechanisms of acute ischemic stroke Stroke health economics, health care resources cost and use

Tracking Information

NCT #
NCT03962127
Collaborators
  • St. Olavs Hospital
  • Helse Midt-Norge
Investigators
Study Director: Bent Indredavik, PhD Prof Norwegian University of Science and Technology