Evaluation of the Effectiveness of the Cardiostory Device in Distinguishing Heart Failure From Other Causes in Patients Presenting With Dyspnea.
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- Enrollment
- 850
- Locations
- 2
- Primary Endpoint
- Diagnostic performance assessment of the CardioStory device.
Study Overview
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.
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts 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 exclusion criteria.
- •Dyspnea clearly of traumatic or allergic origin
Outcomes
Primary Outcomes
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
- 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)
- To evaluate the time required to obtain measurements using the CardioStory device compared with standard clinical assessments.(Day 1)
- To assess the adverse event occurrences of the CardioStory device in the emergency setting.(Day 1)