Cost Comparison of Cardiac Magnetic Resonance Imaging (MRI) Use in Emergency Department (ED) Patients With Chest Pain
13. srpna 2018 aktualizováno: Wake Forest University Health Sciences
Randomized Cost Comparison of Cardiac MRI Use in ED Patients With Chest Pain
The purpose of this study is to investigate the best way to evaluate patients with chest pain in the emergency department.
It compares receiving treatment in an observation unit with admission to the hospital.
Patients treated in the observation unit will undergo cardiac Magnetic Resonance Imaging (MRI) testing.
Patients treated with hospital admission 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.
Přehled studie
Postavení
Dokončeno
Podmínky
Intervence / Léčba
Detailní popis
Almost half of patients presenting to the Emergency Department (ED) with possible cardiac chest pain are at intermediate risk for short term death or infarction. Most are admitted to the hospital for serial ECG's, cardiac biomarkers, cardiology consultation, and stress testing or coronary angiogram. However, the 2007 ACC/AHA guidelines suggest that these patients can be managed in an observation unit (OU). Recently, cardiac magnetic resonance imaging (CMR) has proven more accurate than traditional testing modalities for the diagnosis of acute coronary syndrome (ACS), and has also received endorsement from the American College of Cardiology (ACC)/American Heart Association (AHA) guidelines. Immediate application of CMR in an OU may improve health care utilization compared to standard hospital admission for intermediate risk patients.
Research hypotheses:
- Patients in an OU CMR protocol will have lower cost for the index hospitalization than standard care.
- An OU CMR protocol for patients with intermediate risk chest pain will significantly improve the frequency of correct cardiovascular admission decisions when compared to standard care.
Methods summary:
110 ED patients at intermediate risk for short-term death or infarction, with nondiagnostic Electrocardiograms (ECG) and normal initial cardiac biomarkers, will be randomized to standard care or OU CMR protocols. Subjects in the OU CMR protocol will undergo CMR perfusion and stress testing, followed by serial biomarkers. Standard care subjects will be admitted for usual 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.
Typ studie
Intervenční
Zápis (Aktuální)
110
Fáze
- Nelze použít
Kontakty a umístění
Tato část poskytuje kontaktní údaje pro ty, kteří studii provádějí, a informace o tom, kde se tato studie provádí.
Studijní místa
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North Carolina
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Winston-Salem, North Carolina, Spojené státy, 27157
- Wake Forest University Baptist Medical Center - Emergency Department
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Kritéria účasti
Výzkumníci hledají lidi, kteří odpovídají určitému popisu, kterému se říká kritéria způsobilosti. Některé příklady těchto kritérií jsou celkový zdravotní stav osoby nebo předchozí léčba.
Kritéria způsobilosti
Věk způsobilý ke studiu
18 let a starší (Dospělý, Starší dospělý)
Přijímá zdravé dobrovolníky
Ne
Pohlaví způsobilá ke studiu
Všechno
Popis
Inclusion Criteria:
- Age greater than or equal to 18 years of age at the time of enrollment
- Chest discomfort or other symptoms consistent with possible Acute Coronary Syndrome (ACS) as indicated by the treating physician after obtaining an Electrocardiogram (ECG) and cardiac biomarkers for the patient's evaluation
- Patient requires an inpatient evaluation for their chest pain
- The treating physician feels the patient could be discharged home if cardiac disease was excluded
- Thrombolysis in Myocardial Infarction (TIMI) risk score ≥ 2 OR physician clinical impression of intermediate or high likelihood that the symptoms represent ACS
- Negative pregnancy test (if sexually active, female, and of childbearing age)
Exclusion Criteria:
- Initial troponin I > 1.0 ng/ml
- New ST-segment elevation on any electrocardiogram (≥ 1 mV)
- New ST-segment depression on any electrocardiogram (≥ 2 mV)
- Unable to lie flat
- Hypotension (systolic < 90 mm Hg)
- Contra-indications to MRI(Pacemaker, defibrillator, cerebral aneurysm clips, metallic ocular foreign body, implanted devices, claustrophobia)
- Patient refusal of medical record review and telephone follow-up at 30 days
- Terminal diagnosis with life expectancy less than 3 months
- Pregnancy per patient report or positive pregnancy test (Center for Medicare & Medicaid Services (CMS) exclusion criteria)
- Renal insufficiency(done prior to enrollment)or end stage renal disease
- Chronic liver disease (ex. hepatitis, cirrhosis)
- History of liver, heart, or kidney transplant
Studijní plán
Tato část poskytuje podrobnosti o studijním plánu, včetně toho, jak je studie navržena a co studie měří.
Jak je studie koncipována?
Detaily designu
- Primární účel: Diagnostický
- Přidělení: Randomizované
- Intervenční model: Paralelní přiřazení
- Maskování: Singl
Zbraně a zásahy
Skupina účastníků / Arm |
Intervence / Léčba |
|---|---|
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Experimentální: Emergency Department (ED) Observation unit
Emergency Department observation unit- Cardiac Magnetic Resonance Imaging (MRI) Protocol.
Patients will be transferred to the observation unit and undergo a stress cardiac MRI evaluation.
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After Emergency Department (ED) evaluation, patients are randomized to Observation unit care or standard inpatient care.
Patients in the observation unit will also undergo a stress cardiac MRI.
Patients in the usual care arm may undergo any desired testing, including cardiac MRI, as determined by their treating physician.
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Žádný zásah: Usual care
This is the comparison arm.
Patients are admitted to the hospital and undergo usual care.
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Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
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Cost of Index Hospitalization
Časové okno: Emergency Department (ED) arrival through hospital discharge, median length of stay was 28.1 hours
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Index hospitalization refers to the hospital visit during which the participant was enrolled in the trial.
The primary outcome is examining the cost for this visit.
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Emergency Department (ED) arrival through hospital discharge, median length of stay was 28.1 hours
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Sekundární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
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Correct Admission Decision, Based Upon the Reference Standard of Acute Coronary Syndrome (ACS) at 30 Days
Časové okno: 30 Days
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Participants with ACS and admitted or not experiencing ACS and discharged will be considered a correct admission decision.
Remaining participants will be considered to have incorrect admission decisions.
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30 Days
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The Number of Participants Randomized to the OU and Were Able to Complete CMR Imaging
Časové okno: Emergency Department (ED) arrival through hospital discharge
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The number of participants able to complete the planned imaging sequences will be measured.
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Emergency Department (ED) arrival through hospital discharge
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Number of Participants Who Utilized the Indicated Health Care Procedures
Časové okno: 30d, 3mo, 6mo, and 1 year
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Measured as self report, assessed during telephone follow-up.
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30d, 3mo, 6mo, and 1 year
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Adverse Events During Magnetic Resonance Imaging (MRI) Scanning
Časové okno: Occuring in the MRI scanning suite or within 30 minutes of the last image acquisition.
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Any event leading to early termination of the MRI acquisition, or requiring intervention by a physician, will be considered an adverse event related to MRI, excluding physician termination of image acquisition due to concerns of cardiac ischemia.
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Occuring in the MRI scanning suite or within 30 minutes of the last image acquisition.
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Spolupracovníci a vyšetřovatelé
Zde najdete lidi a organizace zapojené do této studie.
Vyšetřovatelé
- Vrchní vyšetřovatel: Chadwick D Miller, MD, WFUBMC
Publikace a užitečné odkazy
Osoba odpovědná za zadávání informací o studiu tyto publikace poskytuje dobrovolně. Mohou se týkat čehokoli, co souvisí se studiem.
Obecné publikace
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Užitečné odkazy
Termíny studijních záznamů
Tato data sledují průběh záznamů studie a předkládání souhrnných výsledků na ClinicalTrials.gov. Záznamy ze studií a hlášené výsledky jsou před zveřejněním na veřejné webové stránce přezkoumány Národní lékařskou knihovnou (NLM), aby se ujistily, že splňují specifické standardy kontroly kvality.
Hlavní termíny studia
Začátek studia
1. ledna 2008
Primární dokončení (Aktuální)
1. března 2009
Dokončení studie (Aktuální)
1. března 2009
Termíny zápisu do studia
První předloženo
8. května 2008
První předloženo, které splnilo kritéria kontroly kvality
8. května 2008
První zveřejněno (Odhad)
15. května 2008
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Aktuální)
11. září 2018
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
13. srpna 2018
Naposledy ověřeno
1. srpna 2018
Více informací
Termíny související s touto studií
Klíčová slova
Další relevantní podmínky MeSH
Další identifikační čísla studie
- IRB00004120
Informace o lécích a zařízeních, studijní dokumenty
Studuje lékový produkt regulovaný americkým FDA
Ne
Studuje produkt zařízení regulovaný americkým úřadem FDA
Ano
produkt vyrobený a vyvážený z USA
Ne
Tyto informace byly beze změn načteny přímo z webu clinicaltrials.gov. Máte-li jakékoli požadavky na změnu, odstranění nebo aktualizaci podrobností studie, kontaktujte prosím register@clinicaltrials.gov. Jakmile bude změna implementována na clinicaltrials.gov, bude automaticky aktualizována i na našem webu .
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