Efficacy Evaluation of Observation Unit Cardiac Magnetic Resonance Imaging (MRI) in Patients With Intermediate Risk Acute Chest Pain
6 november 2017 bijgewerkt door: 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.
Studie Overzicht
Toestand
Voltooid
Interventie / Behandeling
Gedetailleerde beschrijving
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
Ingrijpend
Inschrijving (Werkelijk)
124
Fase
- Niet toepasbaar
Contacten en locaties
In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.
Studie Locaties
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North Carolina
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Winston-Salem, North Carolina, Verenigde Staten, 27157
- Wake Forest University Baptist Medical Center - Emergency Department
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Deelname Criteria
Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
18 jaar en ouder (Volwassen, Oudere volwassene)
Accepteert gezonde vrijwilligers
Nee
Geslachten die in aanmerking komen voor studie
Allemaal
Beschrijving
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)
Studie plan
Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Diagnostisch
- Toewijzing: Gerandomiseerd
- Interventioneel model: Parallelle opdracht
- Masker: Enkel
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
|---|---|
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Experimenteel: 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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Experimenteel: 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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Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Tijdsspanne |
|---|---|
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Therapeutic efficacy: Length of stay
Tijdsspanne: Duration of Initial Hospitalization
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Duration of Initial Hospitalization
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Secundaire uitkomstmaten
Uitkomstmaat |
Tijdsspanne |
|---|---|
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Therapeutic efficacy: Correct cardiovascular admission decision
Tijdsspanne: Duration of Initial Hospitalization
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Duration of Initial Hospitalization
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Therapeutic efficacy: Non-therapeutic cardiac catheterizations
Tijdsspanne: 30 days
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30 days
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Diagnostic thinking efficacy: change in diagnostic certainty
Tijdsspanne: 30 days
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30 days
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Cost of index hospitalization
Tijdsspanne: Duration of Initial Hospitalization
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Duration of Initial Hospitalization
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Medewerkers en onderzoekers
Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.
Medewerkers
Onderzoekers
- Hoofdonderzoeker: Chadwick Miller, M.D., WFUBMC
Publicaties en nuttige links
De persoon die verantwoordelijk is voor het invoeren van informatie over het onderzoek stelt deze publicaties vrijwillig ter beschikking. Dit kan gaan over alles wat met het onderzoek te maken heeft.
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Nuttige links
Studie record data
Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.
Bestudeer belangrijke data
Studie start
1 maart 2009
Primaire voltooiing (Werkelijk)
1 september 2010
Studie voltooiing (Werkelijk)
1 oktober 2011
Studieregistratiedata
Eerst ingediend
24 maart 2009
Eerst ingediend dat voldeed aan de QC-criteria
24 maart 2009
Eerst geplaatst (Schatting)
25 maart 2009
Updates van studierecords
Laatste update geplaatst (Werkelijk)
8 november 2017
Laatste update ingediend die voldeed aan QC-criteria
6 november 2017
Laatst geverifieerd
1 april 2017
Meer informatie
Termen gerelateerd aan deze studie
Trefwoorden
Aanvullende relevante MeSH-voorwaarden
Andere studie-ID-nummers
- IRB00008247
- AHA Identification # 0980008N
Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .
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