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NCT Number: NCT07685106

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

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.

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Key information

Conditions

Heart Failure Cardiovascular Diseases Dyspnea Heart Diseases Pathological Conditions, Signs and Symptoms Respiration Disorders Respiratory Tract Diseases Signs and Symptoms Signs and Symptoms, Respiratory

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Fattouma bourguiba university hospital, Monastir, Monastir Governorate, Tunisia

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Age ≥ 18 years
  • Recent onset dyspnea (less than 7 days)
  • Informed consent obtained

Exclusion criteria

  • 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

Treatment and study plan

Non invasive cardiac assessment with the CardioStory device

Device

The CardioStory device, is a non-invasive medical technology designed to rapidly (approximately 2 minutes) assess cardiac filling pressure in patients with suspected or established heart failure. It uses proprietary fiber-optic sensors combined with advanced signal processing and analytical algorithms to detect and analyze physiological signals related to cardiac mechanical function. These signals are processed to generate a quantitative estimate of cardiac filling pressure without the need for catheterization, contrast agents, or injectable substances. The measurement is performed non-invasively and is designed to be simple, rapid, and reproducible.

Primary outcomes

  1. Diagnostic performance assessment of the CardioStory device.

    Time frame: 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.

Secondary outcomes

  1. To evaluate the sensitivity and specificity of the CardioStory device for the diagnosis of heart failure.

    Time frame: Day 1

  2. To compare the diagnostic results obtained with CardioStory device with reference diagnostic tools

    Time frame: Day 1

    Evaluating the correlation between CardioStory-derived cardiac filling pressures and NT-proBNP levels, as well as the correlation between CardioStory measurements and echocardiography-derived parameters of cardiac function

  3. To evaluate the time required to obtain measurements using the CardioStory device compared with standard clinical assessments.

    Time frame: Day 1

    Time (in minutes) from initiation of the CardioStory measurement to availability of the diagnostic result, compared with the time required for standard clinical assessments.

  4. To assess the adverse event occurrences of the CardioStory device in the emergency setting.

    Time frame: Day 1

    Safety data will be collected for all participants. Any adverses event occurring within 30 min to 24 hours after the use of the CardioStory device will be documented and recorded

Sponsors and collaborators

Lead sponsor

CardioStory INC

Industry

Collaborators

  • Eshmoun Clinical Research Center
  • Sahloul Hospital of Sousse
  • University Hospital Monastir, Tunis

Registry information

Acronym: CARDIOSTORY TN

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Jul 6, 2026
Registry last updated
Jul 6, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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