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Efficacy Evaluation of Observation Unit Cardiac Magnetic Resonance Imaging (MRI) in Patients With Intermediate Risk Acute Chest Pain

6. november 2017 opdateret af: Wake Forest University Health Sciences
The purpose of this study is to investigate the best way to evaluate patients with chest pain in the emergency department. It compares types of cardiac tests performed while receiving treatment in an observation unit. Patients will either undergo cardiac MRI testing or conventional care testing. Patients treated in the conventional care testing group will undergo the testing their doctor determines is best for them. All patients will undergo follow up to find out if they have had any heart related events.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

Despite spending $12 billion annually on the emergency evaluation of chest pain in the US, only 15% of admitted patients have a cardiac cause of their presenting symptoms. Observation units (OU) improve resource utilization, are endorsed by the ACC/AHA guidelines, but have seen limited implementation in non-low risk chest pain patients due to limitations of traditional cardiac testing. Cardiac magnetic resonance imaging (CMR) is sensitive and specific for ischemia, can simultaneously assess cardiac function and myocardial perfusion, and could revolutionize the diagnostic process for intermediate risk patients with chest pain. The superior accuracy of CMR could decrease testing resulting from false positive results. The high sensitivity for ongoing ischemia could allow imaging in parallel with cardiac markers.

Research hypotheses:

OU-CMR will have superior therapeutic efficacy to OU-conventional testing.

An OU-CMR strategy will have higher diagnostic thinking efficacy than OU-conventional testing.

Methods summary:

To address the question of feasibility of a CMR approach to managing patients at intermediate risk for ACS, we propose a randomized clinical trial of 120 patients at intermediate risk of ACS that present to the ED of Wake Forest University Baptist Medical Center (WFUBMC) for evaluation of chest pain. All patients will receive care in an OU, and will be randomized to CMR, or conventional testing. CMR participants will undergo cardiac markers and CMR testing; conventional testing participants will undergo serial cardiac markers followed by conventional cardiac testing. ACS (infarction, death, coronary revascularization, unstable angina) will be assessed by evaluation of hospital course and phone follow-up at 30 days. Cost of hospital care will be compared among groups.

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

124

Fase

  • Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

  • Forenede Stater
    • North Carolina
      • Winston-Salem, North Carolina, Forenede Stater, 27157
        • Wake Forest University Baptist Medical Center - Emergency Department

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

18 år og ældre (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Beskrivelse

Inclusion Criteria:

  • Age greater than or equal to 18 years
  • Chest discomfort or other symptoms consistent with possible ACS
  • TIMI risk score ≥ 1 or physician impression* of intermediate or high likelihood symptoms represent ACS
  • Patient requires an inpatient or observation unit evaluation for their chest pain
  • The treating physician feels the patient could be discharged home if cardiac disease was excluded
  • ED attending feels patient is safe for observation unit care**

Exclusion Criteria:

  • Initial troponin I > 1.0 ng/ml
  • New ST-segment elevation (≥1mV) or depression (≥2 mV)
  • Contra-indications to MRI (listed below)
  • Unable to lie flat
  • Hypotension (systolic < 90 mm Hg)
  • Renal insufficiency (estimated GFR < 45 cc/min) or end stage renal disease
  • Life expectancy less than 3 months
  • Patient refusal of medical record review and follow-up at 30 days
  • Pregnancy
  • Liver, heart, or kidney transplant
  • Chronic liver disease
  • Unable to speak English or Spanish
  • The ED attending feels that cardiac catheterization is indicated
  • The ED care provider intends to order a CT coronary angiogram

(*)Physicians are encouraged to use the 2007 ACC/AHA guidelines for the management of patients with NSTE ACS as a framework for this assessment.(1)

(**)These patients should generally not be considered for observation unit care: PCI / CAGB in past 6 months, multiple stents, multiple prior MIs

Contraindications to MRI: (Pacemaker, defibrillator, cerebral aneurysm clips, metallic ocular foreign body, implanted devices, claustrophobia)

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Diagnostisk
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Enkelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: 1
Cardiac MRI Protocol. Patients will be transferred to the observation unit and undergo a stress cardiac MRI evaluation.
Andet: OU - Cardiac MRI
During ED evaluation, patients are randomized to cardiac MRI or conventional care testing.
Eksperimentel: 2
Conventional care cardiac testing. Patients will be transferred to the observation unit and undergo cardiac testing as determined by their treating physician.
Andet: OU - Conventional Care Testing
Patients in the conventional testing arm will undergo testing as determined by their treating physician.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Tidsramme
Therapeutic efficacy: Length of stay
Tidsramme: Duration of Initial Hospitalization
Duration of Initial Hospitalization

Sekundære resultatmål

Resultatmål
Tidsramme
Therapeutic efficacy: Correct cardiovascular admission decision
Tidsramme: Duration of Initial Hospitalization
Duration of Initial Hospitalization
Therapeutic efficacy: Non-therapeutic cardiac catheterizations
Tidsramme: 30 days
30 days
Diagnostic thinking efficacy: change in diagnostic certainty
Tidsramme: 30 days
30 days
Cost of index hospitalization
Tidsramme: Duration of Initial Hospitalization
Duration of Initial Hospitalization

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Wake Forest University Health Sciences

Samarbejdspartnere

American Heart Association

Efterforskere

  • Ledende efterforsker: Chadwick Miller, M.D., WFUBMC

Publikationer og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

Generelle publikationer

Hjælpsomme links

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

1. marts 2009

Primær færdiggørelse (Faktiske)

1. september 2010

Studieafslutning (Faktiske)

1. oktober 2011

Datoer for studieregistrering

Først indsendt

24. marts 2009

Først indsendt, der opfyldte QC-kriterier

24. marts 2009

Først opslået (Skøn)

25. marts 2009

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

8. november 2017

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

6. november 2017

Sidst verificeret

1. april 2017

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • IRB00008247
  • AHA Identification # 0980008N

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

Kliniske forsøg med Brystsmerter

Kliniske forsøg med OU - Cardiac MRI

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Sponsorer og samarbejdspartnere

Medicinske tilstande

Narkotikainterventioner

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CROs in Türkiye

Betingelser

Sjældne sygdomme

Narkotikainterventioner

Kosttilskud

Sponsor / samarbejdspartnere

Placeringer

Abonner