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

July 2, 2026 updated by: CardioStory INC
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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Estimated)

850

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Tunisia
      • Sousse, Tunisia, 4054
        • Recruiting
        • Sahloul university hospital
        • Contact:
        • Contact:
        • Principal Investigator:
          • Riadh Boukef, Professor
    • Monastir Governorate
      • Monastir, Monastir Governorate, Tunisia, 5000
        • Recruiting
        • Fattouma bourguiba university hospital
        • Contact:
        • Contact:
        • Principal Investigator:
          • Samir Nouira, Professor

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Probability Sample

Study Population

Adult patients presenting to the emergency department with acute or subacute dyspnea without an established diagnosis. This population represents patients requiring urgent evaluation to differentiate between cardiac and non-cardiac causes of dyspnea.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Patients suffering from Dyspnea
Adult patients presenting to the emergency department with acute dyspnea.
Device: Non invasive cardiac assessment with the CardioStory 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Day 1

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
To evaluate the sensitivity and specificity of the CardioStory device for the diagnosis of heart failure.
Time Frame: Day 1
Day 1
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
Day 1
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.
Day 1
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
Day 1

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

CardioStory INC

Collaborators

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 1, 2025

Primary Completion (Estimated)

December 1, 2026

Study Completion (Estimated)

December 1, 2026

Study Registration Dates

First Submitted

June 26, 2026

First Submitted That Met QC Criteria

July 2, 2026

First Posted (Actual)

July 6, 2026

Study Record Updates

Last Update Posted (Actual)

July 6, 2026

Last Update Submitted That Met QC Criteria

July 2, 2026

Last Verified

July 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CS-HF_DYSP-2025

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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