Efficacy Evaluation of Observation Unit Cardiac Magnetic Resonance Imaging (MRI) in Patients With Intermediate Risk Acute Chest Pain
6. november 2017 oppdatert av: 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.
Studieoversikt
Status
Fullført
Forhold
Intervensjon / Behandling
Detaljert 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.
Studietype
Intervensjonell
Registrering (Faktiske)
124
Fase
- Ikke aktuelt
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiesteder
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North Carolina
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Winston-Salem, North Carolina, Forente stater, 27157
- Wake Forest University Baptist Medical Center - Emergency Department
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Deltakelseskriterier
Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
18 år og eldre (Voksen, Eldre voksen)
Tar imot friske frivillige
Nei
Kjønn som er kvalifisert for studier
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
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
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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Eksperimentell: 1
Cardiac MRI Protocol.
Patients will be transferred to the observation unit and undergo a stress cardiac MRI evaluation.
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During ED evaluation, patients are randomized to cardiac MRI or conventional care testing.
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Eksperimentell: 2
Conventional care cardiac testing.
Patients will be transferred to the observation unit and undergo cardiac testing as determined by their treating physician.
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Patients in the conventional testing arm will undergo testing as determined by their treating physician.
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Hva måler studien?
Primære resultatmål
Resultatmål |
Tidsramme |
|---|---|
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Therapeutic efficacy: Length of stay
Tidsramme: Duration of Initial Hospitalization
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Duration of Initial Hospitalization
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Sekundære resultatmål
Resultatmål |
Tidsramme |
|---|---|
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Therapeutic efficacy: Correct cardiovascular admission decision
Tidsramme: Duration of Initial Hospitalization
|
Duration of Initial Hospitalization
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Therapeutic efficacy: Non-therapeutic cardiac catheterizations
Tidsramme: 30 days
|
30 days
|
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Diagnostic thinking efficacy: change in diagnostic certainty
Tidsramme: 30 days
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30 days
|
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Cost of index hospitalization
Tidsramme: Duration of Initial Hospitalization
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Duration of Initial Hospitalization
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Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Samarbeidspartnere
Etterforskere
- Hovedetterforsker: Chadwick Miller, M.D., WFUBMC
Publikasjoner og nyttige lenker
Den som er ansvarlig for å legge inn informasjon om studien leverer frivillig disse publikasjonene. Disse kan handle om alt relatert til studiet.
Generelle publikasjoner
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Studierekorddatoer
Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.
Studer hoveddatoer
Studiestart
1. mars 2009
Primær fullføring (Faktiske)
1. september 2010
Studiet fullført (Faktiske)
1. oktober 2011
Datoer for studieregistrering
Først innsendt
24. mars 2009
Først innsendt som oppfylte QC-kriteriene
24. mars 2009
Først lagt ut (Anslag)
25. mars 2009
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
8. november 2017
Siste oppdatering sendt inn som oppfylte QC-kriteriene
6. november 2017
Sist bekreftet
1. april 2017
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- IRB00008247
- AHA Identification # 0980008N
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