Efficacy Evaluation of Observation Unit Cardiac Magnetic Resonance Imaging (MRI) in Patients With Intermediate Risk Acute Chest Pain
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 124
- 试验地点
- 2
- 主要终点
- Therapeutic efficacy: Length of stay
研究概览
简要总结
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.
详细描述
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:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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**
排除标准
- •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)
研究组 & 干预措施
1
Cardiac MRI Protocol. Patients will be transferred to the observation unit and undergo a stress cardiac MRI evaluation.
干预措施: OU - Cardiac MRI (Other)
2
Conventional care cardiac testing. Patients will be transferred to the observation unit and undergo cardiac testing as determined by their treating physician.
干预措施: OU - Conventional Care Testing (Other)
结局指标
主要结局
Therapeutic efficacy: Length of stay
时间窗: Duration of Initial Hospitalization
次要结局
- Therapeutic efficacy: Correct cardiovascular admission decision(Duration of Initial Hospitalization)
- Diagnostic thinking efficacy: change in diagnostic certainty(30 days)
- Therapeutic efficacy: Non-therapeutic cardiac catheterizations(30 days)
- Cost of index hospitalization(Duration of Initial Hospitalization)