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

Study acronym: CARDIOSTORY
StatusWithdrawn
PhaseNot specified
Started

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Record History

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  1. Withdrawn before enrolling Sponsor's reason: This record was withdrawn prior to enrollment. The study was subsequently re-registered under the sponsor's Responsible Party as NCT07685106, which reflects the transfer of study conduct from the investigator-initiated phase to the sponsoring compan
    • Enrollment target: estimated 650 to confirmed 0
    • Eligibility criteria expanded, about 6 words
  2. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
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.
Trial Details
NCT Number NCT07147699
Lead Sponsor Hôpital Universitaire Sahloul
Conditions
(from sponsor)		 Dyspnea, Heart Failure Acute
Related terms Dyspnea
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov