Evaluation of the Effectiveness of the Cardiostory Device in Distinguishing Heart Failure From Other Causes in Patients Presenting With Dyspnea.
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 850
- 试验地点
- 2
- 主要终点
- Diagnostic performance assessment of the CardioStory device.
研究概览
简要总结
This is a prospective, observational study conducted in the emergency department. Adult patients presenting with dyspnea will be enrolled, and study data will be collected from routine clinical assessments, including medical history, physical examination, laboratory tests, and echocardiography results, as well as non-invasive cardiovascular measurements obtained using the CardioStory device.
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
- 否
入选标准
- •Age ≥ 18 years
- •Recent onset dyspnea (less than 7 days)
- •Informed consent obtained
排除标准
- •Age inferior to 18 years,
- •Severe comorbidity, hemodynamic compromise or immediate need for mechanical ventilation were exclusion criteria.
- •Dyspnea clearly of traumatic or allergic origin
结局指标
主要结局
Diagnostic performance assessment of the CardioStory device.
时间窗: Day 1
To assess the diagnostic performance of the CardioStory device in differentiating patients with heart failure from those with non-cardiac causes of dyspnea (including respiratory, metabolic etiologies) in patients presenting to the emergency department, using standard clinical assessments as the reference standard.
次要结局
- To evaluate the sensitivity and specificity of the CardioStory device for the diagnosis of heart failure.(Day 1)
- To compare the diagnostic results obtained with CardioStory device with reference diagnostic tools(Day 1)
- To evaluate the time required to obtain measurements using the CardioStory device compared with standard clinical assessments.(Day 1)
- To assess the adverse event occurrences of the CardioStory device in the emergency setting.(Day 1)