Cost Comparison of Cardiac Magnetic Resonance Imaging (MRI) Use in Emergency Department (ED) Patients With Chest Pain
13 agosto 2018 aggiornato da: 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.
Panoramica dello studio
Stato
Completato
Condizioni
Intervento / Trattamento
Descrizione dettagliata
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.
Tipo di studio
Interventistico
Iscrizione (Effettivo)
110
Fase
- Non applicabile
Contatti e Sedi
Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.
Luoghi di studio
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North Carolina
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Winston-Salem, North Carolina, Stati Uniti, 27157
- Wake Forest University Baptist Medical Center - Emergency Department
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Criteri di partecipazione
I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.
Criteri di ammissibilità
Età idonea allo studio
18 anni e precedenti (Adulto, Adulto più anziano)
Accetta volontari sani
No
Sessi ammissibili allo studio
Tutto
Descrizione
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
Piano di studio
Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Diagnostico
- Assegnazione: Randomizzato
- Modello interventistico: Assegnazione parallela
- Mascheramento: Separare
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
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Sperimentale: 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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Nessun intervento: Usual care
This is the comparison arm.
Patients are admitted to the hospital and undergo usual care.
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Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
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Cost of Index Hospitalization
Lasso di tempo: 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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Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
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Correct Admission Decision, Based Upon the Reference Standard of Acute Coronary Syndrome (ACS) at 30 Days
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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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Collaboratori e investigatori
Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.
Investigatori
- Investigatore principale: Chadwick D Miller, MD, WFUBMC
Pubblicazioni e link utili
La persona responsabile dell'inserimento delle informazioni sullo studio fornisce volontariamente queste pubblicazioni. Questi possono riguardare qualsiasi cosa relativa allo studio.
Pubblicazioni generali
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Collegamenti utili
Studiare le date dei record
Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.
Studia le date principali
Inizio studio
1 gennaio 2008
Completamento primario (Effettivo)
1 marzo 2009
Completamento dello studio (Effettivo)
1 marzo 2009
Date di iscrizione allo studio
Primo inviato
8 maggio 2008
Primo inviato che soddisfa i criteri di controllo qualità
8 maggio 2008
Primo Inserito (Stima)
15 maggio 2008
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
11 settembre 2018
Ultimo aggiornamento inviato che soddisfa i criteri QC
13 agosto 2018
Ultimo verificato
1 agosto 2018
Maggiori informazioni
Termini relativi a questo studio
Parole chiave
Termini MeSH pertinenti aggiuntivi
Altri numeri di identificazione dello studio
- IRB00004120
Informazioni su farmaci e dispositivi, documenti di studio
Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti
No
Studia un dispositivo regolamentato dalla FDA degli Stati Uniti
Sì
prodotto fabbricato ed esportato dagli Stati Uniti
No
Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .
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