Evaluation of the Effectiveness of the Cardiostory Device in Distinguishing Heart Failure From Other Causes in Patients Presenting With Dyspnea. (CARDIOSTORY TN)
2. juli 2026 opdateret af: 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.
Studieoversigt
Status
Rekruttering
Betingelser
Intervention / Behandling
Undersøgelsestype
Observationel
Tilmelding (Anslået)
850
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
-
-
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Sousse, Tunesien, 4054
- Rekruttering
- Sahloul University Hospital
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Kontakt:
- Riadh Boukef, Professor
- Telefonnummer: +21698676745
- E-mail: riadboukef@gmail.com
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Kontakt:
- Houda Chaouch, PhD
- Telefonnummer: 97453468
- E-mail: chawech_houda@yahoo.fr
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Ledende efterforsker:
- Riadh Boukef, Professor
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Monastir Governorate
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Monastir, Monastir Governorate, Tunesien, 5000
- Rekruttering
- Fattouma Bourguiba University Hospital
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Kontakt:
- Samir Nouira, Professor
- Telefonnummer: +21673106046
- E-mail: semir.nouira.urg@gmail.com
-
Kontakt:
- Houda Chaouch, PhD
- Telefonnummer: +21697453468
- E-mail: chawech_houda@yahoo.fr
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Ledende efterforsker:
- Samir Nouira, Professor
-
-
Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
- Voksen
- Ældre voksen
Tager imod sunde frivillige
Ingen
Prøveudtagningsmetode
Sandsynlighedsprøve
Studiebefolkning
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.
Beskrivelse
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
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
Kohorter og interventioner
Gruppe / kohorte |
Intervention / Behandling |
|---|---|
|
Patients suffering from Dyspnea
Adult patients presenting to the emergency department with acute dyspnea.
|
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.
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Diagnostic performance assessment of the CardioStory device.
Tidsramme: Day 1
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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
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
To evaluate the sensitivity and specificity of the CardioStory device for the diagnosis of heart failure.
Tidsramme: Day 1
|
Day 1
|
|
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To compare the diagnostic results obtained with CardioStory device with reference diagnostic tools
Tidsramme: 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
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Day 1
|
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To evaluate the time required to obtain measurements using the CardioStory device compared with standard clinical assessments.
Tidsramme: 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
|
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To assess the adverse event occurrences of the CardioStory device in the emergency setting.
Tidsramme: 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
|
Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart (Faktiske)
1. september 2025
Primær færdiggørelse (Anslået)
1. december 2026
Studieafslutning (Anslået)
1. december 2026
Datoer for studieregistrering
Først indsendt
26. juni 2026
Først indsendt, der opfyldte QC-kriterier
2. juli 2026
Først opslået (Faktiske)
6. juli 2026
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
6. juli 2026
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
2. juli 2026
Sidst verificeret
1. juli 2026
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- CS-HF_DYSP-2025
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
Studerer et amerikansk FDA-reguleret lægemiddelprodukt
Ingen
Studerer et amerikansk FDA-reguleret enhedsprodukt
Ja
produkt fremstillet i og eksporteret fra U.S.A.
Ja
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