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临床试验/NCT06031909
NCT06031909招募中不适用

Multimodal Assessment of Frailty in Acute Stroke Patients Treated at a Certified Stroke-unit

University of Giessen1 个研究点 分布在 1 个国家目标入组 200 人开始时间: 2023年8月1日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
200
试验地点
1
主要终点
Rate of good functional outcome

研究概览

简要总结

The goal of this study is to investigate the influence of frailty on clinical and stroke characteristics, treatment and outcomes in patients with acute stroke.

The main questions it aims to answer are:

  1. How prevalent is frailty in patients with stroke?
  2. Which impairments (e.g. undernutrion, impaired mobility, laboratory markers) contribute to frailty?
  3. Is the outcome of frail patients worse than those without?
  4. Are in-hospital complications more frequent in frail patients than those without?

详细描述

Stroke is one of the most common causes of disability and mortality worldwide. A recognized complication in stroke patients is frailty, which is associated with increased costs, poorer prognosis, and higher mortality rates. However, there is currently no uniform definition or diagnostic criteria for frailty in stroke patients, and there is a need for standardized frailty assessments in this patient population.

The aim of this study is to determine the prevalence of frailty in stroke patients at the Stroke Unit of the University Hospital Giessen and to analyze the associated characteristics and impacts on clinical outcomes. A multimodal frailty assessment will be conducted to capture a wide range of frailty features and investigate their significance. The study includes all stroke patients admitted to the certified stroke- unit of the University Hospital Giessen within a 3-month period. There are no inclusion criteria related to age, gender, or type of stroke.

The multimodal frailty assessment encompasses determining appropriate blood values (e.g., CRP, albumin), assessing muscle strength/mass through handheld dynamometry and sonographic muscle diameter, utilizing scores like the Clinical Frailty Scale (CFS) and the Groningen Frailty Indicator (GFI), evaluating nutritional status (BMI), collecting image-based frailty data (e.g., sarcopenia, cerebral white matter lesions, lacunar strokes, brain atrophy), and conducting suitable one-year follow-ups. Additionally, demographic and clinical data such as age, gender, type of stroke, and treatment details will be recorded.

The primary outcome is the prevalence of frailty among stroke patients. Secondary outcomes include the characteristics and impacts of frailty in stroke patients, including correlations between various frailty features and clinical outcomes such as length of hospital stay, mortality, and functional outcome.

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 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • treated at the certified stroke-unit of the Dpt. of Neurology, University Hospital Giessen
  • diagnosis of ischemic (including transient ischemic attack) or hemorrhagic stroke

排除标准

  • withdrawal of care within 24 hours after admission

结局指标

主要结局

Rate of good functional outcome

时间窗: 12 months

Percentage of patients achieving a score of 0 to 2 on the modified Rankin scale (higher values indicating worse outcome, ranging from 0, no deficit, to 6, death) at 12 months follow-up

Prevalence of frailty in stroke patients

时间窗: 30 days

Percentage of patients with frailty treated for stroke compared to all patients admitted for stroke

次要结局

  • Major adverse cardiovascular events (MACE)(From date of admission until MACE or last follow-up, whichever comes first, assessed up to 12 months.)
  • Patient reported outcome measures (PROM)(12 months)
  • Rate of rehospitalization(12 months)
  • Mortality rate(From date of admission until death or last follow-up, whichever comes first, assessed up to 12 months.)
  • Functional impairment in activities of daily living(12 months)
  • Cognitive outcome(12 months)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Stefan Gerner

Principal Investigator, Associate professor

University of Giessen

研究点 (1)

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