Evaluation of the Effectiveness of the CardioStory Device in Distinguishing Heart Failure From Other Causes in Patients Presenting With Dyspnea

Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorHôpital Universitaire Sahloul

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 volunteers

Qualifiers

• 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

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • cardiostory

    Device

    measure the pressure of remplissage

Treatment groups

No treatment groups listed

Trial outcomes

Primary outcomes

1

Diagnostic accuracy of the CardioStory device in identifying heart failure (sensitivity, specificity, PPV, NPV).

Time frame
12 hours

Secondary outcomes

1

o Concordance between CardioStory and standard diagnostic tools o Time to diagnosis o Ease of use and practicality (via physician questionnaire)

Time frame
12 hours

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

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