- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT01665521
Effektevaluering af HJERTE-vejen i akutmodtagelsespatienter med akutte brystsmerter (HEART Pathway)
Studieoversigt
Status
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
Cirka 8-10 millioner patienter, der klager over brystsmerter, kommer til en akutafdeling (ED) årligt i USA. De samlede omkostninger til evaluering af brystsmerter er blevet anslået til 5-10 milliarder dollars årligt, men alligevel bliver kun 10 % af disse patienter i sidste ende diagnosticeret med et akut koronarsyndrom. American College of Cardiology/American Heart Association (ACC/AHA) retningslinjer anbefaler, at patienter med lav risiko for akut koronarsyndrom skal modtage serielle hjertemarkører efterfulgt af objektiv hjertetest (stresstest eller hjertebilleddannelse). Mange har dog stillet spørgsmålstegn ved værdien af objektiv hjertetest hos alle lavrisikopatienter. Hjertetest for alle patienter med lav risiko for akut koronarsyndrom (ACS) er ikke bæredygtig ud fra et sundhedsfagligt kvalitetsmæssigt eller økonomisk perspektiv. Ud over at øge omkostningerne er objektiv hjertetest forbundet med et betydeligt antal falske positive og ikke-diagnostiske tests, som fører til yderligere unødvendige og ofte invasive procedurer.
Implementering af nøjagtige risikostratificeringsbehandlingsveje designet til at eliminere unødvendige hjertetests kan forbedre effektiviteten og kvaliteten af behandlingen ved at reducere falsk positive/ikke-diagnostiske test, stråling og omkostninger. HEART-vejen, som kombinerer en klinisk beslutningsregel, HEART-score og to serielle troponinmålinger, er en nyligt udviklet behandlingsvej designet til at identificere brystsmertepatienter til tidlig udskrivning uden objektiv test.
Primær hypotese: HEART Pathway vil, sammenlignet med sædvanlig pleje, reducere 30 dages objektiv hjertetest, hospitalsopholdslængde og omkostninger, samtidig med at patientsikkerheden opretholdes.
Metoder: Deltagere (n=282) med risiko for ACS vil blive rekrutteret til et klinisk forsøg fra Wake Forest Baptist Medical Center (WFBMC) ED. Patienterne vil ligeligt blive randomiseret til HEART Pathway eller Usual Care. HEART Pathway-deltagerens behandlende læge vil følge HEART Pathway-retningslinjerne for at identificere patienter, der skal indlægges på hospitalet eller observationsenheden til hjertetest eller udskrives hjem uden test. Normal Care-deltagers behandlende læger vil beslutte, om patienterne skal udskrives til hjemmet eller indlægges på hospitalet eller observationsenheden baseret på ACC/AHA-retningslinjer uden at bruge HJERTET-vejen.
Undersøgelsestype
Tilmelding (Faktiske)
Fase
- Ikke anvendelig
Kontakter og lokationer
Studiesteder
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North Carolina
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Winston-Salem, North Carolina, Forenede Stater, 27157
- Wake Forest Wake Forest University Baptist Medical Center - Emergency Department
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Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Beskrivelse
Inklusionskriterier:
- Alder større end eller lig med 21 år
- Ubehag i brystet eller andre symptomer i overensstemmelse med mulig ACS
- Den behandlende læge mener, at patienten kunne blive udskrevet hjem, hvis hjertesygdom blev udelukket
Ekskluderingskriterier:
- Ny ST-segment elevation i sammenhængende ledninger på ethvert elektrokardiogram (>/= 1 mV)
- Ustabile vitale tegn: symptomatisk hypotension på indskrivningstidspunktet (systolisk < 90 mm Hg), takykardi (HR>120), bradykardi (HR <40) og hypoxæmi (<90 % pulsoximetri på rumluft eller normal iltstrøm i hjemmet sats)
- Terminaldiagnose med forventet levetid mindre end 1 år
- En ikke-hjertemedicinsk, kirurgisk eller psykiatrisk sygdom, som af udbyderen er bestemt til at kræve indlæggelse, øge risikoen for objektiv hjertetest eller forhindre øjeblikkelig udledning efter negativ test.
- Forudgående tilmelding
- Manglende evne eller vilje til at give samtykke og overholde undersøgelsesprocedurer
- Ikke-engelsktalende
Delstudie I & II
Inklusionskriterier:
- ED behandlende læger
Ekskluderingskriterier:
- ED behandlende læger, der afslår at deltage
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Enkelt
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
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Eksperimentel: HJERTE-sti
HEART Pathway vil blive brugt til klinisk beslutningstagning i realtid.
Læger vil modtage behandlingsanbefalinger i henhold til HEART Pathway, baseret på HEART-score og serielle hjertebiomarkører.
Dette vil hjælpe læger med at identificere lavrisikopatienter til tidlig udskrivning uden objektiv hjertetest.
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Under ED-evaluering randomiseres patienterne til HEART Pathway eller sædvanlige plejearme.
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Ingen indgriben: Sædvanlig pleje
Konventionel Care hjertetest.
Patienterne vil gennemgå en hjertetest som bestemt af deres behandlende læge.
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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Objektiv hjertetest (stresstest eller hjertebilleddannelse) inden for 30 dage
Tidsramme: 30 dage
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Hyppighed af objektiv hjertetest inden for 30 dage
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30 dage
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Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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Omkostninger, liggetid, tilbagevendende ED-besøg og ikke-indeksindlæggelse for brystsmerter.
Tidsramme: 30 dage
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30 dage
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Objektiv hjertetest (stresstest eller hjertebilleddannelse), omkostninger, opholdslængde og tilbagevendende ED-besøg og non-index hospitalsindlæggelse for brystsmerter.
Tidsramme: 1 år
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1 år
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Indeks objektiv hjertetestfrekvens
Tidsramme: Varighed af Indeks Hospitalsindlæggelse, gennemsnitligt 1 til 2 dage
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andel af patienter, der modtager stresstestmetoder, koronar computertomografi angiografi eller invasiv kateterangiografi ved indeksbesøget
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Varighed af Indeks Hospitalsindlæggelse, gennemsnitligt 1 til 2 dage
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Indeks Sygehusindlæggelsesprocent
Tidsramme: Varighed af Indeks Hospitalsindlæggelse, gennemsnitligt 1 til 2 dage
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Andel af patienter indlagt til indlæggelse eller observation under indeksbesøget
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Varighed af Indeks Hospitalsindlæggelse, gennemsnitligt 1 til 2 dage
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Tidlig udledningshastighed
Tidsramme: Varighed af Indeks Hospitalsindlæggelse, gennemsnitligt 1 til 2 dage
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Andel af patienter, der udskrives fra akutmodtagelsen uden at opfylde det sammensatte endepunkt for indeks hospitalsindlæggelse eller indeks objektiv hjertetest
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Varighed af Indeks Hospitalsindlæggelse, gennemsnitligt 1 til 2 dage
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Sammensat af 30 dages hospitalsindlæggelse og objektiv hjertetest
Tidsramme: 30 dage
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30 dage
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Andre resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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Større uønskede hjertehændelser (MACE)
Tidsramme: 30 dage og 1 år
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30 dage og 1 år
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Gik glip af MACE
Tidsramme: 30 dage og 1 år
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MACE forekommer hos patienter, der udskrives uden objektiv hjertetest.
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30 dage og 1 år
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Udbyder overholdelse af HEART Pathway
Tidsramme: Varighed af Indeks Hospitalsindlæggelse, gennemsnitligt 1 til 2 dage
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Varighed af Indeks Hospitalsindlæggelse, gennemsnitligt 1 til 2 dage
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Inter-rater pålidelighed af HEART Pathway
Tidsramme: Varighed af Index ED-besøget, mindre end 1 dag
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Varighed af Index ED-besøget, mindre end 1 dag
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Samarbejdspartnere og efterforskere
Samarbejdspartnere
Efterforskere
- Ledende efterforsker: Simon A Mahler, MD, Wake Forest Baptist Medical Center
Publikationer og nyttige links
Generelle publikationer
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- IRB00021074
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