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临床试验/NCT00564382
NCT00564382已完成不适用

Cardiac MRI for the Diagnosis of Unstable Angina/ NSTEMI in the Emergency Room

University of Calgary2 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2007年11月最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
100
试验地点
2
主要终点
The difference between the Time to diagnosis, measured from the first negative Troponin to the publication of the CMR study report

研究概览

简要总结

In this study, we investigate the role of Cardiac Magnetic Resonance Imaging in patients with suspected, but not yet proven, "acute cardiac syndrome ACS". Patients are included if they presented to the local Emergency Department with chest pain, but the first tests in the Emergency Department are negative or not clearly indicative of cardiac ischemia. For example, the first lab value Troponin T is negative or borderline elevated; or the first ECG is not clearly indicative of ischemia. The standard procedure for these patients is to wait 4-6 hours and then repeat the test; if they continue to be negative, the patients are discharged home, if the have become positive, an invasive coronary artery angiography has to be performed. We think, that a CMR study can shorten the time needed to make the decision of either "discharge" or "admit to CCU and perform a coronary artery angiography". CMR has been shown to be the gold standard for heart function (thus, can see even subtle wall motion abnormalities), for tissue characterization (so-called T2-weighted images can identify tissue edema (swelling); perfusion images can identify areas with reduced blood supply; late enhancement images can safely identify fibrotic or irreversibly damaged tissue) and can even be used to stress the patients to exclude a critical or non-critical narrowing of coronary arteries.

The primary endpoint of this study will be the impact of CMR on the time-to-decision in these patients.

It should be possible to a) identify all patients WITH an acute infarct by CMR and send them to a cath lab sooner compared to waiting for a second test; b) identify all patients WITHOUT an acute infarct and c) perform a stress test in those patients to exclude severe coronary artery disease.

详细描述

Background

Unstable angina (UA) and non-ST-elevation myocardial infarction (NSTEMI) are serious forms of acute coronary syndromes1. They require rapid clinical assessment, diagnosis and therapeutical intervention. A delay in the diagnosis and a delay in treatment may lead to serious complications such as ventricular arrhythmias, heart failure and sudden cardiac death. In NSTEMI, time delay to diagnosis might lead to irreversible loss of salvageable myocardium.

The current recommendations of the American Heart Association for the management of patients with UA/ NSTEMI rely on the patient's symptoms, ECG changes and serum markers (Troponin) 1. The algorithm for diagnosis and therapy is straight-forward for patients presenting with positive Troponin and/ or ongoing ECG changes; however, an up to 8 hours delay occurs in a patient presenting with chest pain, but without diagnostic ECG changes and negative Troponins (figure 1). During this period, repeat ECGs are recommended to observe changes, and the Troponin test will be repeated at 8 hours.

This delay in diagnosis and treatment might be abbreviated by the diagnosis of UA/NSTEMI with the help of cardiac MRI.

A growing body of evidence supports the capability of MRI to diagnose and rule out UA/ NSTEMI:

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Diagnostic
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 18+ years of age, informed consent obtained
  • Chest pain, suggestive of coronary artery disease, plus at least one more point from the TIMI risk score (TIMI score ≥2)
  • Troponin is negative on 1st draw; based on the Emergency Room Physician's discretion, a 2nd Troponin draw is indicated and pending

排除标准

  • ST elevation on ECG, new Q-waves or dynamic ST-segment changes, 2nd or 3rd degree AV-block
  • Unstable patients
  • PCI or myocardial infarction within 3 months
  • Ferromagnetic objects precluding MRI imaging (e.g., pacemaker, defibrillator, cerebral aneurysm clip, metal in eye, insulin pumps, neural stimulators, cochlea implants)
  • Extreme claustrophobia
  • Inability to lie flat

研究组 & 干预措施

1

Other

Patients with ACS in the emergency department and primary tests (ECG, TNT) negative for myocardial ischemia

干预措施: Cardiac magnetic Resonance study (Procedure)

结局指标

主要结局

The difference between the Time to diagnosis, measured from the first negative Troponin to the publication of the CMR study report

时间窗: prospective

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Oliver Strohm

adunct Research Associate Professor

University of Calgary

研究点 (2)

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