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临床试验/NCT00871260
NCT00871260已完成4 期

Stress Testing and Cardiac Magnetic Resonance

University of Chicago1 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2009年4月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
4 期
状态
已完成
入组人数
20
试验地点
1
主要终点
Major Adverse Cardiovascular Events

研究概览

简要总结

The purpose of this study is to better define the role of a comprehensive stress MRI (which includes myocardial perfusion imaging, optimized coronary imaging, and myocardial scar imaging) in medical practice and in patient health management. Information gathered from the healthy volunteers that participate in this study will be compared to information from the coronary artery disease patients in this study in order to help further our understanding.

详细描述

Coronary artery disease is a major cause of morbidity and mortality in the United States. Currently, the presence of physiologically significant coronary disease is most commonly diagnosed using non-invasive imaging tests such as a nuclear stress test or an echo stress test. Unfortunately, nuclear stress tests require the use of ionizing radiation and have a limited spatial resolution. On the other hand, echo stress tests are dependent of adequate imaging windows. Adenosine stress testing combined with cardiac magnetic resonance (CMR) is a rapidly evolving technique for diagnosing significant coronary disease. It does not use ionizing radiation and has excellent image quality. In a recent meta-analysis of 14 studies with a total of 1,183 patients, the sensitivity and specificity of stress CMR for detecting significant coronary disease was 91% and 81%. Additionally, 2 studies have shown that patients with a normal stress CMR study have a <1% risk of having a cardiovascular event during the ensuing year. Another important advantage to stress CMR is the ability to fully quantify myocardial blood flow which may improve the diagnostic accuracy of stress CMR. In addition to perfusion imaging, CMR can directly visualize the coronary arteries, detect extremely small myocardial infarctions, and precisely measure the left ventricular function.

Although adenosine stress CMR is a rapidly maturing test, several important challenges exist. First, many patients find it difficult to tolerate the common side effects of adenosine in the confined space of the MRI scanner. Secondly, many patients under the influence of adenosine and its side effects cannot adequately hold their breath during image acquisition making image interpretation more difficult and quantitative analysis very time consuming. Finally, because adenosine must be continuously infused during a contrast-enhanced stress CMR, 2 separate intravenous (I.V.) catheters are needed. Most of the undesirable effects of adenosine are mediated through the adenosine A(2B) and A(3) receptors; where as, its desired vasodilator effects are mediated through the A(2A) receptor. The FDA recently approved an adenosine A(2A) receptor specific stress testing agent called regadenoson which is administered as a 10 second bolus and has an improved side effect and safety profile when compared to adenosine. With its improved tolerability and ease of use, regadenoson is a more ideal stress testing agent to use with CMR.

The purpose of this study is to determine whether a comprehensive regadenoson stress cardiac magnetic resonance study which includes myocardial perfusion imaging, optimized coronary imaging, and myocardial scar imaging provides incremental prognostic information over a clinical evaluation that includes nuclear stress testing.

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

  • Suspected coronary artery disease
  • Symptoms of possible coronary artery disease

排除标准

  • Acute ST-elevation myocardial infarction
  • Second or third degree AV block
  • Severe Renal Disease (Glomerular Filtration Rate (GFR) <30cc/min or hemodialysis)
  • Contra-indications to MRI (i.e. Implantable Cardioverter Defibrillator (ICD), pacemaker, aneurysm clip, etc)
  • Hemodynamic instability
  • Inability to provide informed consent
  • Severe claustrophobia
  • Pregnancy
  • Age <18 years

研究组 & 干预措施

Open Label

Other

Approximately 25 healthy volunteers will be recruited as controls. Scan will be done with regadenoson contrast.

干预措施: regadenoson (Drug)

结局指标

主要结局

Major Adverse Cardiovascular Events

时间窗: 3 years

Major adverse cardiovascular events, such as death, myocardial infarction, unstable angina, congestive heart failure, or cerebral vascular accident.

次要结局

  • Relationship Between SPECT and CMR Results of Myocardial Perfusion Imaging(1 year)
  • Optimization of Coronary Imaging Using CMR(1 year)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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