Evaluation of the Effectiveness of the Cardiostory Device in Distinguishing Heart Failure From Other Causes in Patients Presenting With Dyspnea.
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Non invasive cardiac assessment with the CardioStory device.
- Who it may be relevant to
- Registry conditions: Heart Failure, Dyspnea. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Tunisia
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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.
Interventions
- 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
Primary outcome measures
- Diagnostic performance assessment of the CardioStory device. [Time frame: Day 1]
Secondary outcome measures (4)
- To evaluate the sensitivity and specificity of the CardioStory device for the diagnosis of heart failure. [Time frame: Day 1]
- To compare the diagnostic results obtained with CardioStory device with reference diagnostic tools [Time frame: Day 1]
- To evaluate the time required to obtain measurements using the CardioStory device compared with standard clinical assessments. [Time frame: Day 1]
- To assess the adverse event occurrences of the CardioStory device in the emergency setting. [Time frame: Day 1]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
Tunisia · 2 centers
- Fattouma bourguiba university hospital — Monastir
- Sahloul university hospital — Sousse
Identifiers
NCT: NCT07685106 · CS-HF_DYSP-2025