Cognition and Affect After Stroke: a Prospective Evaluation of Risks
概览
- 阶段
- 不适用
- 干预措施
- 未指定
- 疾病 / 适应症
- Vascular Cognitive Impairment
- 发起方
- Maastricht University Medical Center
- 入组人数
- 250
- 试验地点
- 1
- 主要终点
- vascular cognitive impairment
- 状态
- 已完成
- 最后更新
- 3年前
概览
简要总结
Stroke is a leading cause of disability, affecting about 34,000 to 41,000 individuals in the Netherlands of middle and old age every year. Due to the aging of the population, this figure will increase considerably over the next decades (Struijs et al., 2005). Twenty-five percent of stroke patients die within one month, making stroke a major risk factor for premature death in developed countries. According to the World Health Organization, stroke is the third leading cause of the burden of disease in middle and high-income countries (World Health Organization, 2008). It has a significant negative impact on quality of life of both the patients as well as their caregivers and significant others. Surviving stroke patients often struggle with its manifold and lifelong lasting consequences, with 35 percent of patients being functionally dependent one year after stroke (Wolfe, 2000) and cognitive and emotional changes which are found up to two years post-stroke (Rasquin, Lodder, & Verhey, 2005). Depression, apathy, and cognitive impairment are very prevalent and significantly contribute to the burden of the disease, but their etiologies remain poorly understood.
The aim of the CASPER study is to gain more insight into the etiologies of post-stroke depression (PSD), post-stroke apathy (PSA), vascular cognitive impairment (VCI), and post-stroke dementia. Therefore, the primary objectives are to identify biomarker-based predictors of PSD, PSA, and VCI. A secondary aim is to study effect modulation, especially the interaction between cerebrovascular disease, neurodegenerative changes and inflammation in post-stroke dementia.
CASPER is a prospective clinical cohort study of 250 first-ever ischemic stroke patients with serial assessments at baseline (10 to 12 weeks after stroke), six and 12 months after baseline. Another wave (36 month after baseline) was later added.
研究者
入排标准
入选标准
- •First-ever or recurrent ischemic or hemorrhagic stroke
- •MMSE score ≥15 (to ensure valid testing)
- •Written informed consent
- •Sufficient knowledge of the Dutch language
- •Preferably participation of an informant
排除标准
- •Age younger than 40 years (to exclude atypical strokes)
- •Pre-stroke dementia (assessed by a semi-structured interview with a relative, based on clinical diagnosis or IQ-CODE) in the five years prior to stroke
- •Psychiatric and neurological disease other than the qualifying event known to affect cognition such as schizophrenia, bipolar disorder, substance abuse, Parkinson's disease, or epilepsy
- •Current episode of depression at admission (as evidenced by medical records and patient or informant interview). In contrast, a lifetime history of depression will not be considered as a reason for exclusion as this is considered a potential risk factor for PSD
- •Severe aphasia (as it interferes with understanding and following test instructions)
结局指标
主要结局
vascular cognitive impairment
时间窗: 12 months
defined as a score smaller or equal to 1.5 standard deviations below the general population mean in two or more cognitive domains, based on available norm scores for age, gender and level of education for the Dutch general population
post-stroke depression
时间窗: 12 months
measured by the Mini International Neuropsychiatric Interview and the Montgomery-Asberg Depression Rating Scale to assess severity. In addition, the Hospital Anxiety and Depression Scale is used to identify levels of anxiety and depression.
post-stroke apathy
时间窗: 12 months
assessed by the Apathy Evaluation Scale (informant- and clinician rated version is used)
次要结局
- change in cognitive function(12 months)
- incident post-stroke dementia(12 months)
- change in quality of life(12 months)
- change in functional ability(12 months)