jRCT2012240059进行中（未招募）不适用
Performance validation study of the Frailty Finder in elderly patients with heart failure
未提供0 个研究点目标入组 430 人开始时间: 待定最近更新:
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 430
- 主要终点
- Evaluation of error between the Clinical Frailty Scale (CFS) calculated by investigational devices and labeling results by Japanese Circulation Society board-certified cardiologists
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Single Arm Study
- 干预模型
- Single Assignment
- 主要目的
- Diagnostic Purpose
- 盲法
- Open(masking Not Used)
入排标准
- 年龄范围
- 75age old over 至 No limit（—）
- 性别
- All
入选标准
- •Patients meeting all of the following criteria will be selected:
- •Patients diagnosed with chronic heart failure based on the diagnostic criteria outlined in the Japanese Circulation Society's Guidelines for the Management of Acute and Chronic Heart Failure.
- •Patients aged 75 years or older at the time of consent.
- •Patients who have received a thorough explanation of this clinical trial and provided written informed consent.
排除标准
- •Subjects meeting any of the following criteria will be excluded from this clinical trial:
- •Patients unable to walk according to instructions.
- •Patients deemed unsuitable for the clinical trial at the discretion of the physician.
结局指标
主要结局
Evaluation of error between the Clinical Frailty Scale (CFS) calculated by investigational devices and labeling results by Japanese Circulation Society board-certified cardiologists
Assessed by QWK
次要结局
- Evaluation of error in CFS calculated by investigational medical devices and labeling results by Japanese Circulation Society board-certified cardiologists
- Agreement rate for each CFS between CFS calculated by investigational medical devices and labeling results by Japanese Circulation Society board-certified cardiologists
- Evaluation of differences in results from repeated tests
- Agreement rate for each CFS between CFS calculated by investigational medical devices at each medical institution and labeling results by Japanese Circulation Society board-certified cardiologists
- Frequency of misclassification by two or more grades of CFS calculated by the application compared to labeling results by Japanese Circulation Society board-certified cardiologists
研究者
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