- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT07427303
Fokuseret Ekkokardiografi for Almenpraktiserende Læger (UPCOMING)
KLINISK GENNEMFØRLIGHED AF ULTRAPORTABELT HJERTEULTRALYDSSCANNING UDFØRT I ALMEN PRAKSIS TIL IDENTIFIKATION AF KARDIELATER
Our society is characterized by a steady improvement in the standard of living of its inhabitants, which is reflected, among other things, in improved healthcare and quality of life (longer life expectancy, lower infant mortality, treatment of chronic diseases, cancer plan). Many factors contribute to this, but technological innovations and therapeutic advances are the main ones. This positive overall picture should not obscure the fact that there are significant regional disparities.
For more than 15 years, the former Lower Normandy region (Calvados, Manche, and Orne), like many other regions in France, has been marked by increasingly complex access to healthcare, whether for primary care or for so-called specialty disciplines. This situation is gradually leading to the creation of medical deserts. There are many reasons for this (numerus clausus, sociological changes, urbanization of young practitioners, attraction of small rural towns by medium-sized cities), which are chronic and have no clearly identified solution.
This situation complicates patient care and, in some cases, represents a major public health challenge, such as in the treatment of heart failure (HF), which affects more than one million people in France, or 2.3% of the adult population. For 2.3 times more deaths each year than strokes and five times more than myocardial infarctions.
Some healthcare innovations can reduce the consequences of these areas of stress. In the field of cardiology, recent initiatives based on the creation of specialized cardiology and telemedicine care teams have been proposed. In primary care, point-of-care solutions enable many tests to be performed on an outpatient basis. Imaging plays a central role in patient care, and ultrasound is often the first-line modality in cardiology. Technological innovations in this field have made it possible to miniaturize ultrasound machines to such an extent that some of them can now be considered POCUS (point-of-care ultrasound). Their reduced manufacturing costs, combined with the maturity of the technique, make it possible to offer simplified acquisition protocols adapted to specific questions, known as targeted clinical ultrasound.
This simplification/miniaturization of ultrasound equipment has facilitated the spread of this technique outside the field of cardiology and now allows for its use by general practitioners close to patients, specifically for screening purposes. Many diseases would benefit from early screening in order to reduce hospitalizations, mortality, and societal costs. In cardiology, this approach remains difficult because the majority of patients admitted to healthcare facilities have already developed the disease. HF is characterized by an initial silent phase which, if left untreated, inevitably leads to complications and death. It is responsible for 200,000 hospitalizations per year in France, causing the deaths of 70,000 people. Certain signs, grouped under the French acronym EPOF, appear early on and can be warning signs, but they are often vague and unfamiliar to the general public. This fact is well illustrated by the results of a survey conducted by the Heart Failure and Cardiomyopathy Group (GICC) of the French Society of Cardiology (SFC) in 2017 (5,000 subjects representative of the French population aged 18 to 80). This survey noted that two-thirds of subjects presenting four of these signs (EPOF) had not consulted a cardiologist in the 12 months prior to the questionnaire. In the majority of cases, these patients, whether asymptomatic or paucisymptomatic (EPOF), have morphological and functional abnormalities of the heart, which are the first step toward more severe complications and can be detected by cardiac echocardiography.
There is currently a favorable alignment between echocardiography as a public health need (early detection of conditions that can lead to heart failure) and frontline practitioners (general practitioners). This alignment could lead to the definition of new practices and a new care pathway. While echocardiography is technically feasible in a general practitioner's office, its implementation remains to be evaluated (HAS report). This report emphasizes the lack of data in the literature to identify use cases and clinical impact in general medicine in France.
Studieoversigt
Status
Intervention / Behandling
Undersøgelsestype
Tilmelding (Anslået)
Fase
- Ikke anvendelig
Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
- Ældre voksen
Tager imod sunde frivillige
Beskrivelse
Inklusionskriterier:
- Mænd og kvinder på 65 år eller ældre uden hjertesymptomer og med en behandlet eller ubehandlet kardiovaskulær risikofaktor (hypertension og/eller diabetes og/eller dyslipidemi) eller
Voksne mænd og kvinder med et af følgende tegn:
- Dyspnæ ved anstrengelse i stadium I-II
- Ødem i nedre ekstremiteter
- Uforklarlig træthed
- Vægtøgning
- Uforklarlig hoste
- Tidligere karpaltunnelsoperation (søgning efter tegn på myokardieinfiltration ved kardial amyloidose)
Eksklusionskriterier:
- Patienter med arytmi eller ventrikulær eller supraventrikulær hyperekscitabilitet.
Symptomatiske patienter:
- Dyspnæ ved anstrengelse (NYHA >2)
- Hjertebanken
- Ubehag
- Brystsmerter
- Overvægtige personer med BMI >35
- Patienter med brystimplantater
- Patienter under vergemål, værgemål eller retlig beskyttelse
- Patienter uden sygesikringsdækning eller tilsvarende
- Patienter med kendt hjertesygdom
- Patienter, der har haft en kardiologisk konsultation inden for de sidste 5 år
- Personer med kendt hjertesygdom, uanset om de er under kontrol eller ej.
- Kendt klapsygdom (uanset om den er under kontrol eller ej)
- Kendt koronar hjertesygdom (uanset om den er under kontrol eller ej)
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Diagnostisk
- Tildeling: N/A
- Interventionel model: Enkelt gruppeopgave
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
|
Aktiv komparator: Målrettet Eko Gruppe
|
Målrettet klinisk ultralydsundersøgelse
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Klinisk mulighed for hjerteultralyd udført på en almen læges kontor inden for det specifikke rammeværk af den foreslåede indsamlingsprotokol.
Tidsramme: Den målrettede ultralydsundersøgelse udført af praktiserende læge vil blive gennemgået af specialisten inden for 72 timer.
|
Overensstemmelse mellem fortolkningen af almen læge og ekspertens fortolkning af ECC1-undersøgelsen udført af almen læge på deres klinik i undersøgelsespopulationen
|
Den målrettede ultralydsundersøgelse udført af praktiserende læge vil blive gennemgået af specialisten inden for 72 timer.
|
Samarbejdspartnere og efterforskere
Sponsor
Datoer for undersøgelser
Studer store datoer
Studiestart (Anslået)
Primær færdiggørelse (Anslået)
Studieafslutning (Anslået)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Faktiske)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- 23-0197
- 2023-A02068-37 (Registry Identifier: Agence nationale de sécurité du médicament et des produits de santé)
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
Studerer et amerikansk FDA-reguleret lægemiddelprodukt
Studerer et amerikansk FDA-reguleret enhedsprodukt
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