MIDNOR-STROKE A Prospective Observation Study of a Cohort of 800 Patients With First Ever Ischemic Stroke in Central Norway
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 800
- 试验地点
- 8
- 主要终点
- Mortality after first ischemic stroke
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •Focal neurological symptoms turned out to be not stroke-related
- •Significant physical disabilities prior to stroke (defined as Modified Rankin ≥5).
研究组 & 干预措施
First time ischemic stroke
Patients with a first event of ischemic stroke admitted to hospitals in Central Norway.
干预措施: no intervention (Other)
结局指标
主要结局
Mortality after first ischemic stroke
时间窗: 3 months
Measured with data from Norwegian Death Registry
The incidence of recurrent stroke after first ever ischemic stroke
时间窗: 3 months
Measured by using data from the Norwegian Stroke Registry and other Norwegian Cardiovascular registries including patient questionnaires
The incidence of recurrent stroke after first ever ischemic stroke
时间窗: 1 year
Measured by using data from the Norwegian Stroke Registry and other Norwegian Cardiovascular registries including patient questionnaires
The incidence of recurrent stroke after first ever ischemic stroke
时间窗: 3 years
Measured by using data from the Norwegian Stroke Registry and other Norwegian Cardiovascular registries including patient questionnaires
The incidence of recurrent stroke after first ever ischemic stroke
时间窗: 5 years
Measured by using data from the Norwegian Stroke Registry and other Norwegian Cardiovascular registries including patient questionnaires
Mortality after first ischemic stroke
时间窗: 1 year
Measured with data from Norwegian Death Registry
Mortality after first ischemic stroke
时间窗: 3 years
Measured with data from Norwegian Death Registry
Mortality after first ischemic stroke
时间窗: 5 years
Measured with data from Norwegian Death Registry
Functional disability after stroke
时间窗: 3 months after stroke
Modified rankin scale 3 - 5 (the degree of disability, total range 0 - 6, value above 2 represents a worse outcome)
Functional disability after stroke
时间窗: 1 year after stroke
Modified rankin scale 3 - 5 (the degree of disability, total range 0 - 6,value above 2 represents a worse outcome)
Functional disability after stroke
时间窗: 3 years after stroke
Modified rankin scale 3 - 5 (the degree of disability, total range 0 - 6, value above 2 represents a worse outcome)
Functional disability after stroke
时间窗: 5 years after stroke
Modified rankin scale 3 - 5 (the degree of disability, total range 0 - 6, value above 2 represents a worse outcome)
Health-related quality of life after stroke
时间窗: 3 months after stroke
EQ-5D-5L (5 Levels from 1-5 in 5 categories where values above 2 represents reduced life quality)
Health-related quality of life after stroke
时间窗: 1 year after stroke
EQ-5D-5L(5 Levels from 1-5 in 5 categories where values above 1 represents reduced life quality)
Health-related quality of life after stroke
时间窗: 3 years after stroke
EQ-5D-5L(5 Levels from 1-5 in 5 categories where values above 1 represents reduced life quality)
Health-related quality of life after stroke
时间窗: 5 years after stroke
EQ-5D-5L (5 Levels from 1-5 in 5 categories where values above 1 represents reduced life quality)
The incidence of recurrent stroke after first ever ischemic stroke
时间窗: 10 years
Measured by using data from the Norwegian Stroke Registry and other Norwegian Cardiovascular registries including patient questionnaires
Mortality after first ischemic stroke
时间窗: 10 years
Measured with data from Norwegian Death Registry
Functional disability after stroke
时间窗: 10 years after stroke
Modified rankin scale 3 - 5 (the degree of disability, total range 0 - 6, value above 2 represents a worse outcome)
Health-related quality of life after stroke
时间窗: 10 years after stroke
EQ-5D-5L (5 Levels from 1-5 in 5 categories where values above 1 represents reduced life quality)
次要结局
- Proportion of patients reaching secondary prevention targets(3 months, 1, 3, 5 and 10 years)
- Cost-benefit analysis(1, 5 and 10 years)