About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
• Age ≥ 18 years
Recent onset dyspnea (less than 7 days)
Informed consent obtained
Disqualifiers
• 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
Trial population
every patient consulting with dyspnea
Trial design
Cohort
Prospective
Treatments tested in this trial
cardiostory
Devicemeasure the pressure of remplissage
Treatment groups
Trial outcomes
Primary outcomes
Diagnostic accuracy of the CardioStory device in identifying heart failure (sensitivity, specificity, PPV, NPV).
Secondary outcomes
o Concordance between CardioStory and standard diagnostic tools o Time to diagnosis o Ease of use and practicality (via physician questionnaire)
Locations
Sponsors and contacts
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