- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT01035047
Randomisert undersøkelse av brystsmertediagnostiske strategier
Studieoversikt
Status
Forhold
Intervensjon / Behandling
Detaljert beskrivelse
Til tross for at de bruker 12 milliarder dollar årlig på nødevaluering av brystsmerter i USA, har bare 15 % av innlagte pasienter en hjerteårsak til symptomene deres. Kliniske beslutningsenheter (CDU-er) forbedrer ressursutnyttelsen og er et anbefalt behandlingsalternativ av American College of Cardiology / American Heart Association, men er underutnyttet hos pasienter med ikke-lavrisiko brystsmerte på grunn av svakhetene ved tradisjonell hjertetesting. Cardiac magnetic resonance imaging (CMR) er sensitiv og spesifikk for iskemi, kan samtidig vurdere hjertefunksjon og myokardperfusjon, og kan revolusjonere den diagnostiske prosessen for pasienter med middels risiko med brystsmerter. Den overlegne nøyaktigheten til CMR kan redusere testing og invasive prosedyrer. Den høye følsomheten for pågående iskemi kan tillate bildebehandling parallelt med hjertemarkører. Som et resultat kan CMR forbedre omsorgen for akuttmottak (ED) pasienter med middels risiko brystsmerter. Effektiviteten og sikkerheten til CMR har imidlertid ikke blitt grundig testet i CDU-innstillingen.
Primær hypotese: En CDU-CMR-strategi vil redusere forekomsten av sammensetningen av revaskularisering, re-hospitalisering og tilbakevendende hjertetesting etter 90 dager sammenlignet med en strategi for døgnbehandling.
Metoder: Deltakere (n=146) med middels risiko for akutt koronarsyndrom (ACS) vil bli rekruttert til en klinisk studie fra Wake Forest University Baptist Medical Center (WFUBMC) ED. Deltakerne vil bli like randomisert til CDU-CMR eller døgnbehandling. CDU-CMR-deltakere vil gjennomgå hvile- og stress-CMR-avbildning parallelt med serielle hjertemarkører. Deltakere i døgnbehandling vil gjennomgå serielle hjertemarkører etterfulgt av eksisterende hjertetesting som bestemt av deres behandlere. Det primære resultatet er sammensetningen av 90 dagers revaskularisering, re-hospitalisering og tilbakevendende hjertetesting. Sekundærutfallet er indeks sykehusinnleggelse liggetid. Sikkerhetshendelser inkluderer ACS etter utskrivning, dødelighet og stresstestrelaterte bivirkninger.
Studietype
Registrering (Faktiske)
Fase
- Ikke aktuelt
Kontakter og plasseringer
Studiesteder
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North Carolina
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Winston-Salem, North Carolina, Forente stater, 27157
- Wake Forest University Baptist Medical Center
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Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Beskrivelse
Inklusjonskriterier:
- Alder over eller lik 21 år på innmeldingstidspunktet
- Ubehag i brystet eller andre symptomer forenlig med mulig ACS som indikert av den behandlende legen etter innhenting av EKG og hjertebiomarkører for pasientens evaluering
- Trombolyse ved hjerteinfarkt (TIMI) risikoscore >/= 2 eller legeinntrykk av intermediære eller høye sannsynlighetssymptomer representerer ACS
- Pasienten krever en stasjonær eller CDU-evaluering for brystsmerter
- Den behandlende legen mener at pasienten kan skrives ut hjem hvis hjertesykdom ble utelukket
- Den behandlende legen føler at pasienten er trygg for CDU-behandling
Pretest sannsynlighetsvurdering Vurderingen av middels risiko for utvikling av ACS vil være basert på en TIMI risikoskåre >/= 2 og/eller et styresertifisert/styrekvalifisert akuttlege klinisk inntrykk av middels eller høy sannsynlighet for at symptomene representerer ACS. Leger oppfordres til å bruke retningslinjene fra American College of Cardiology (ACC)/American Heart Association (AHA) fra 2007 som rammeverk for denne vurderingen.
Ekskluderingskriterier:
- Forhøyede hjertebiomarkører
- Ny ST-segmenthøyde på ethvert elektrokardiogram (>/= 1 mV)
- Ny ST-segmentdepresjon på ethvert elektrokardiogram (>/= 2 mV)
- Kjent induserbar hjerteiskemi uten påfølgende revaskularisering
- Klarer ikke legge seg flat
- Symptomatisk hypotensjon ved registreringstidspunktet (systolisk < 90 mm Hg)
- Kontraindikasjoner for MR (eksempler: pacemaker, defibrillator, cerebrale aneurismeklips, metallisk okulært fremmedlegeme, implanterte enheter, alvorlig klaustrofobi)
- Pasientens avslag eller manglende evne til å etterkomme journalgjennomgang og oppfølging
- Terminaldiagnose med forventet levealder mindre enn 3 måneder
- For tiden gravid
- Kreatininclearance < 45 ml/min ved registreringstidspunktet eller klinisk bekymring for akutt nyreskade
- Kronisk leversykdom med en kreatininclearance på <60 ml/min ved registreringstidspunktet
- Hepato-renalt syndrom
- Historie om lever-, hjerte- eller nyretransplantasjon
- Bekreftet angioplastikk, stentplassering eller koronar bypasstransplantasjon (CABG) i løpet av de siste 6 månedene
Studieplan
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Diagnostisk
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Enkelt
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
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Ingen inngripen: Døgnomsorg
Dette er sammenligningsarmen.
Pasienter legges inn på sykehus og gjennomgår vanlig behandling.
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Eksperimentell: CDU-CMR-protokoll
Pasienter vil bli overført til klinisk beslutningsenhet og gjennomgå en stress-hjerte-MR-evaluering.
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Etter ED-evaluering blir pasienter randomisert til klinisk beslutningsenhet eller døgnbehandling.
Pasienter i klinisk beslutningsenhet vil også gjennomgå en stresshjerte-MR.
Pasienter i døgnavdelingen kan gjennomgå hvilken som helst ønsket testing, inkludert hjerte-MR, som bestemt av deres behandlende lege.
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Hva måler studien?
Primære resultatmål
Resultatmål |
Tidsramme |
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Sammensetningen av revaskularisering, re-hospitalisering og tilbakevendende hjertetesting gjennom 90 dager.
Tidsramme: Indeks sykehusinnleggelse gjennom 90 dager
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Indeks sykehusinnleggelse gjennom 90 dager
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Sekundære resultatmål
Resultatmål |
Tidsramme |
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Lengden på oppholdet
Tidsramme: Varighet av indekssykehusinnleggelse, gjennomsnittlig 1-2 dager
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Varighet av indekssykehusinnleggelse, gjennomsnittlig 1-2 dager
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Akutt koronarsyndrom
Tidsramme: Indeks Utskrivning fra sykehus gjennom 90 dager
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Indeks Utskrivning fra sykehus gjennom 90 dager
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Dødelighet
Tidsramme: Indeks sykehusinnleggelse gjennom 90 dager
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Indeks sykehusinnleggelse gjennom 90 dager
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Stresstest-relatert bivirkning
Tidsramme: Indeks sykehusinnleggelse gjennom 90 dager
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Indeks sykehusinnleggelse gjennom 90 dager
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Samarbeidspartnere og etterforskere
Samarbeidspartnere
Etterforskere
- Hovedetterforsker: Chadwick Miller, M.D., WFUBMC
Publikasjoner og nyttige lenker
Generelle publikasjoner
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- Karha J, Gibson CM, Murphy SA, Dibattiste PM, Cannon CP; TIMI Study Group. Safety of stress testing during the evolution of unstable angina pectoris or non-ST-elevation myocardial infarction. Am J Cardiol. 2004 Dec 15;94(12):1537-9. doi: 10.1016/j.amjcard.2004.08.033.
- Hollander JE, Blomkalns AL, Brogan GX, Diercks DB, Field JM, Garvey JL, Gibler WB, Henry TD, Hoekstra JW, Holroyd BR, Hong Y, Kirk JD, O'Neil BJ, Jackson RE; Multidisciplinary Standardized Reporting Criteria Task Force. Standardized reporting guidelines for studies evaluating risk stratification of ED patients with potential acute coronary syndromes. Acad Emerg Med. 2004 Dec;11(12):1331-40. doi: 10.1197/j.aem.2004.08.033. No abstract available.
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- Myocardial infarction redefined--a consensus document of The Joint European Society of Cardiology/American College of Cardiology Committee for the redefinition of myocardial infarction. Eur Heart J. 2000 Sep;21(18):1502-13. doi: 10.1053/euhj.2000.2305.
- Farkouh ME, Smars PA, Reeder GS, Zinsmeister AR, Evans RW, Meloy TD, Kopecky SL, Allen M, Allison TG, Gibbons RJ, Gabriel SE. A clinical trial of a chest-pain observation unit for patients with unstable angina. Chest Pain Evaluation in the Emergency Room (CHEER) Investigators. N Engl J Med. 1998 Dec 24;339(26):1882-8. doi: 10.1056/NEJM199812243392603.
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- Patel MR, Dehmer GJ, Hirshfeld JW, Smith PK, Spertus JA; American College of Cardiology Foundation Appropriateness Criteria Task Force; Society for Cardiovascular Angiography and Interventions; Society of Thoracic Surgeons; American Association for Thoracic Surgery; American Heart Association, and the American Society of Nuclear Cardiology Endorsed by the American Society of Echocardiography; Heart Failure Society of America; Society of Cardiovascular Computed Tomography. ACCF/SCAI/STS/AATS/AHA/ASNC 2009 Appropriateness Criteria for Coronary Revascularization: a report by the American College of Cardiology Foundation Appropriateness Criteria Task Force, Society for Cardiovascular Angiography and Interventions, Society of Thoracic Surgeons, American Association for Thoracic Surgery, American Heart Association, and the American Society of Nuclear Cardiology Endorsed by the American Society of Echocardiography, the Heart Failure Society of America, and the Society of Cardiovascular Computed Tomography. J Am Coll Cardiol. 2009 Feb 10;53(6):530-53. doi: 10.1016/j.jacc.2008.10.005.
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- Schneider EC, Leape LL, Weissman JS, Piana RN, Gatsonis C, Epstein AM. Racial differences in cardiac revascularization rates: does "overuse" explain higher rates among white patients? Ann Intern Med. 2001 Sep 4;135(5):328-37. doi: 10.7326/0003-4819-135-5-200109040-00009.
- Smith SC Jr, Feldman TE, Hirshfeld JW Jr, Jacobs AK, Kern MJ, King SB 3rd, Morrison DA, O'Neill WW, Schaff HV, Whitlow PL, Williams DO, Antman EM, Smith SC Jr, Adams CD, Anderson JL, Faxon DP, Fuster V, Halperin JL, Hiratzka LF, Hunt SA, Jacobs AK, Nishimura R, Ornato JP, Page RL, Riegel B; American College of Cardiology/American Heart Association Task Force on Practice Guidelines; ACC/AHA/SCAI Writing Committee to Update the 2001 Guidelines for Percutaneous Coronary Intervention. ACC/AHA/SCAI 2005 guideline update for percutaneous coronary intervention: a report of the American College of Cardiology/American Heart Association Task Force on Practice Guidelines (ACC/AHA/SCAI Writing Committee to Update the 2001 Guidelines for Percutaneous Coronary Intervention). J Am Coll Cardiol. 2006 Jan 3;47(1):e1-121. doi: 10.1016/j.jacc.2005.12.001. No abstract available.
- Miller CD, Lindsell CJ, Khandelwal S, Chandra A, Pollack CV, Tiffany BR, Hollander JE, Gibler WB, Hoekstra JW. Is the initial diagnostic impression of "noncardiac chest pain" adequate to exclude cardiac disease? Ann Emerg Med. 2004 Dec;44(6):565-74. doi: 10.1016/j.annemergmed.2004.03.021. Erratum In: Ann Emerg Med. 2005 Jan;45(1):87.
- Miller CD, Banerjee A, Mahaffey KW, Kontos MC, Fermann G, Pollack CV Jr, Antman E, Aylward P, Goodman SG, Santos R, Ferguson JJ, Califf RM, Hoekstra JW. Treatment and outcomes of patients with evolving myocardial infarction: experiences from the SYNERGY trial. Eur Heart J. 2007 May;28(9):1079-84. doi: 10.1093/eurheartj/ehm016. Epub 2007 Apr 3.
- Miller CD, Fermann GJ, Lindsell CJ, Mahaffey KW, Peacock WF, Pollack CV, Hollander JE, Diercks DB, Gibler WB, Hoekstra JW; EMCREG-International itrACS Investigators. Initial risk stratification and presenting characteristics of patients with evolving myocardial infarctions. Emerg Med J. 2008 Aug;25(8):492-7. doi: 10.1136/emj.2007.052183.
- Miller C, Hwang W, Hoekstra J, Lefebvre C, Case D, Hundley WG. Randomized comparison of observation unit plus stress cardiac MRI and hospital admission. Journal of Cardiovascular Magnetic Resonance 2009;11(Suppl 1):O103.
- Ferreira-Gonzalez I, Permanyer-Miralda G, Busse JW, Bryant DM, Montori VM, Alonso-Coello P, Walter SD, Guyatt GH. Methodologic discussions for using and interpreting composite endpoints are limited, but still identify major concerns. J Clin Epidemiol. 2007 Jul;60(7):651-7; discussion 658-62. doi: 10.1016/j.jclinepi.2006.10.020. Epub 2007 Feb 23.
- Tsushima Y, Aoki J, Endo K. Contribution of the diagnostic test to the physician's diagnostic thinking: new method to evaluate the effect. Acad Radiol. 2003 Jul;10(7):751-5. doi: 10.1016/s1076-6332(03)80120-4.
- Therneau TM, Grambsch PM, Fleming TR. Martingale-based residuals for survival models 10.1093/biomet/77.1.147. Biometrika 1990;77(1):147-60.
- Miller CD, Case LD, Little WC, Mahler SA, Burke GL, Harper EN, Lefebvre C, Hiestand B, Hoekstra JW, Hamilton CA, Hundley WG. Stress CMR reduces revascularization, hospital readmission, and recurrent cardiac testing in intermediate-risk patients with acute chest pain. JACC Cardiovasc Imaging. 2013 Jul;6(7):785-94. doi: 10.1016/j.jcmg.2012.11.022. Epub 2013 May 8.
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- IRB00010410
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Legemiddel- og utstyrsinformasjon, studiedokumenter
Studerer et amerikansk FDA-regulert medikamentprodukt
Studerer et amerikansk FDA-regulert enhetsprodukt
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