Cost Comparison of Cardiac Magnetic Resonance Imaging (MRI) Use in Emergency Department (ED) Patients With Chest Pain
13 августа 2018 г. обновлено: 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.
Обзор исследования
Статус
Завершенный
Вмешательство/лечение
Подробное описание
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.
Тип исследования
Интервенционный
Регистрация (Действительный)
110
Фаза
- Непригодный
Контакты и местонахождение
В этом разделе приведены контактные данные лиц, проводящих исследование, и информация о том, где проводится это исследование.
Места учебы
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North Carolina
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Winston-Salem, North Carolina, Соединенные Штаты, 27157
- Wake Forest University Baptist Medical Center - Emergency Department
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Критерии участия
Исследователи ищут людей, которые соответствуют определенному описанию, называемому критериям приемлемости. Некоторыми примерами этих критериев являются общее состояние здоровья человека или предшествующее лечение.
Критерии приемлемости
Возраст, подходящий для обучения
18 лет и старше (Взрослый, Пожилой взрослый)
Принимает здоровых добровольцев
Нет
Полы, имеющие право на обучение
Все
Описание
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
Учебный план
В этом разделе представлена подробная информация о плане исследования, в том числе о том, как планируется исследование и что оно измеряет.
Как устроено исследование?
Детали дизайна
- Основная цель: Диагностика
- Распределение: Рандомизированный
- Интервенционная модель: Параллельное назначение
- Маскировка: Одинокий
Оружие и интервенции
Группа участников / Армия |
Вмешательство/лечение |
|---|---|
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Экспериментальный: 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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Без вмешательства: Usual care
This is the comparison arm.
Patients are admitted to the hospital and undergo usual care.
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Что измеряет исследование?
Первичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
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Cost of Index Hospitalization
Временное ограничение: Emergency Department (ED) arrival through hospital discharge, median length of stay was 28.1 hours
|
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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Вторичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
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Correct Admission Decision, Based Upon the Reference Standard of Acute Coronary Syndrome (ACS) at 30 Days
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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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Соавторы и исследователи
Здесь вы найдете людей и организации, участвующие в этом исследовании.
Следователи
- Главный следователь: Chadwick D Miller, MD, WFUBMC
Публикации и полезные ссылки
Лицо, ответственное за внесение сведений об исследовании, добровольно предоставляет эти публикации. Это может быть что угодно, связанное с исследованием.
Общие публикации
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Полезные ссылки
Даты записи исследования
Эти даты отслеживают ход отправки отчетов об исследованиях и сводных результатов на сайт ClinicalTrials.gov. Записи исследований и сообщаемые результаты проверяются Национальной медицинской библиотекой (NLM), чтобы убедиться, что они соответствуют определенным стандартам контроля качества, прежде чем публиковать их на общедоступном веб-сайте.
Изучение основных дат
Начало исследования
1 января 2008 г.
Первичное завершение (Действительный)
1 марта 2009 г.
Завершение исследования (Действительный)
1 марта 2009 г.
Даты регистрации исследования
Первый отправленный
8 мая 2008 г.
Впервые представлено, что соответствует критериям контроля качества
8 мая 2008 г.
Первый опубликованный (Оценивать)
15 мая 2008 г.
Обновления учебных записей
Последнее опубликованное обновление (Действительный)
11 сентября 2018 г.
Последнее отправленное обновление, отвечающее критериям контроля качества
13 августа 2018 г.
Последняя проверка
1 августа 2018 г.
Дополнительная информация
Термины, связанные с этим исследованием
Ключевые слова
Дополнительные соответствующие термины MeSH
Другие идентификационные номера исследования
- IRB00004120
Информация о лекарствах и устройствах, исследовательские документы
Изучает лекарственный продукт, регулируемый FDA США.
Нет
Изучает продукт устройства, регулируемый Управлением по санитарному надзору за качеством пищевых продуктов и медикаментов США.
Да
продукт, произведенный в США и экспортированный из США.
Нет
Эта информация была получена непосредственно с веб-сайта clinicaltrials.gov без каких-либо изменений. Если у вас есть запросы на изменение, удаление или обновление сведений об исследовании, обращайтесь по адресу register@clinicaltrials.gov. Как только изменение будет реализовано на clinicaltrials.gov, оно будет автоматически обновлено и на нашем веб-сайте. .