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
- 尚未招募
- 入组人数
- 650
- 主要终点
- Diagnostic accuracy of the CardioStory device in identifying heart failure (sensitivity, specificity, PPV, NPV).
研究概览
简要总结
The CARDIOSTORY.TN study is a prospective observational study at Sahloul University Hospital (Sousse, Tunisia) evaluating the CardioStory device for distinguishing heart failure (HF) from other causes of acute dyspnea.
Background: Dyspnea is common in emergencies, and differentiating cardiac from non-cardiac causes is often delayed by the limits of echocardiography and BNP tests. CardioStory is a rapid (~2 minutes), non-invasive tool that measures cardiac filling pressure, a key HF marker.
Objectives:
Primary: Assess CardioStory's diagnostic accuracy.
Secondary: Compare it with echocardiography and NT-proBNP, evaluate ease of use, and measure time to diagnosis.
Methods:
Adults (≥18) with acute dyspnea (<7 days) included; unstable or traumatic/allergic cases excluded.
CardioStory results will be compared to standard diagnostics.
Sample size: 850 patients over 12 months.
Outcome: If accurate, CardioStory could be a fast, practical diagnostic tool for emergency settings.
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 accuracy of the CardioStory device in identifying heart failure (sensitivity, specificity, PPV, NPV).
时间窗: 12 hours
次要结局
- o Concordance between CardioStory and standard diagnostic tools o Time to diagnosis o Ease of use and practicality (via physician questionnaire)(12 hours)
研究者
Riadh Boukef
professor
Hôpital Universitaire Sahloul