A Non-interventional Observational Clinical Study to Document the Clinical Course of Patients 12 Months or More Following an Ischaemic Stroke
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 39
- 试验地点
- 7
- 主要终点
- Compare functional assessment scores collected in this study with the preceding RN-CS-0001 study
研究概览
简要总结
A non-interventional observational clinical study to document the clinical course of patients at 12 months or more following an ischaemic stroke
详细描述
Primary objective:
To document and better define the prognostic characteristics of residual disability 12 months or more following an ischaemic stroke in patients that originally participated in the preceding clinical study RN-CS-0001.
Other objective:
To inform the design of efficient Phase 2/3 studies when screening potentially efficacious interventions for signals of activity which merit further development.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Cross Sectional
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Capacity to give informed consent or witnessed informed consent in the event that the patient is unable to sign informed consent due to physical impairments.
- •Participation in the preceding study RN-CS-0001
- •Completion of at least one of the 4 functional assessment tests (ARAT, BI, NIHSS, mRS) at any time point on the previous study RN-CS-0001
- •Ability to participate in all assessments and attend all visits
排除标准
- •Any additional incidence of stroke (Ischaemic or Haemorrhagic) since participation in the previous study RN-CS-0001 (since the last CS-0001 assessment visit date).
- •Incidence of significant other disease that judged by the investigator would confound completion of all functional assessments (not excluding patients that can complete at least one functional assessment with no confounding factor from significant other disease).
结局指标
主要结局
Compare functional assessment scores collected in this study with the preceding RN-CS-0001 study
时间窗: 12-months
Compare functional assessment scores collected in RN-CS-0002 with the preceding RN-CS-0001 study to better understand stroke symptom recovery and progress
次要结局
未报告次要终点