Dyspnea, Heart Failure
Conditions
Keywords
dyspnea, Heart failure, non-cardiac causes of dyspnea, cardiostory, cardiac assessment device, cardiac causes of dyspnea
Brief summary
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
DEVICENon 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.
Sponsors
CardioStory INC
Eshmoun Clinical Research Center
Sahloul Hospital of Sousse
University Hospital Monastir, Tunis
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Diagnostic performance assessment of the CardioStory device. | 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
| Measure | Time frame | Description |
|---|---|---|
| To evaluate the sensitivity and specificity of the CardioStory device for the diagnosis of heart failure. | Day 1 | — |
| To compare the diagnostic results obtained with CardioStory device with reference diagnostic tools | 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 |
| To evaluate the time required to obtain measurements using the CardioStory device compared with standard clinical assessments. | 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. |
| To assess the adverse event occurrences of the CardioStory device in the emergency setting. | 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 |
Countries
Tunisia
Outcome results
None listed