Efficacy Evaluation of Observation Unit Cardiac Magnetic Resonance Imaging (MRI) in Patients With Intermediate Risk Acute Chest Pain
6 de novembro de 2017 atualizado por: 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.
Visão geral do estudo
Status
Concluído
Condições
Intervenção / Tratamento
Descrição detalhada
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.
Tipo de estudo
Intervencional
Inscrição (Real)
124
Estágio
- Não aplicável
Contactos e Locais
Esta seção fornece os detalhes de contato para aqueles que conduzem o estudo e informações sobre onde este estudo está sendo realizado.
Locais de estudo
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North Carolina
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Winston-Salem, North Carolina, Estados Unidos, 27157
- Wake Forest University Baptist Medical Center - Emergency Department
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Critérios de participação
Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.
Critérios de elegibilidade
Idades elegíveis para estudo
18 anos e mais velhos (Adulto, Adulto mais velho)
Aceita Voluntários Saudáveis
Não
Gêneros Elegíveis para o Estudo
Tudo
Descrição
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)
Plano de estudo
Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Diagnóstico
- Alocação: Randomizado
- Modelo Intervencional: Atribuição Paralela
- Mascaramento: Solteiro
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
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Experimental: 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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Experimental: 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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O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Prazo |
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Therapeutic efficacy: Length of stay
Prazo: Duration of Initial Hospitalization
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Duration of Initial Hospitalization
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Medidas de resultados secundários
Medida de resultado |
Prazo |
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Therapeutic efficacy: Correct cardiovascular admission decision
Prazo: Duration of Initial Hospitalization
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Duration of Initial Hospitalization
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Therapeutic efficacy: Non-therapeutic cardiac catheterizations
Prazo: 30 days
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30 days
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Diagnostic thinking efficacy: change in diagnostic certainty
Prazo: 30 days
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30 days
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Cost of index hospitalization
Prazo: Duration of Initial Hospitalization
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Duration of Initial Hospitalization
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Colaboradores e Investigadores
É aqui que você encontrará pessoas e organizações envolvidas com este estudo.
Patrocinador
Colaboradores
Investigadores
- Investigador principal: Chadwick Miller, M.D., WFUBMC
Publicações e links úteis
A pessoa responsável por inserir informações sobre o estudo fornece voluntariamente essas publicações. Estes podem ser sobre qualquer coisa relacionada ao estudo.
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Links úteis
Datas de registro do estudo
Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.
Datas Principais do Estudo
Início do estudo
1 de março de 2009
Conclusão Primária (Real)
1 de setembro de 2010
Conclusão do estudo (Real)
1 de outubro de 2011
Datas de inscrição no estudo
Enviado pela primeira vez
24 de março de 2009
Enviado pela primeira vez que atendeu aos critérios de CQ
24 de março de 2009
Primeira postagem (Estimativa)
25 de março de 2009
Atualizações de registro de estudo
Última Atualização Postada (Real)
8 de novembro de 2017
Última atualização enviada que atendeu aos critérios de controle de qualidade
6 de novembro de 2017
Última verificação
1 de abril de 2017
Mais Informações
Termos relacionados a este estudo
Palavras-chave
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- IRB00008247
- AHA Identification # 0980008N
Essas informações foram obtidas diretamente do site clinicaltrials.gov sem nenhuma alteração. Se você tiver alguma solicitação para alterar, remover ou atualizar os detalhes do seu estudo, entre em contato com register@clinicaltrials.gov. Assim que uma alteração for implementada em clinicaltrials.gov, ela também será atualizada automaticamente em nosso site .
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