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临床试验/NCT01995955
NCT01995955已完成不适用

The Proposed Study is to Validate a New Non-invasive Imaging Technique for Evaluation of Cardiac Microciculation in Coronary Artery Disease With a Comparison With Validated Technique Invasive, Which is Measure of Index of Myocardial Resistance

University Hospital, Grenoble2 个研究点 分布在 1 个国家目标入组 45 人开始时间: 2013年6月24日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
45
试验地点
2
主要终点
coronary microcirculation

研究概览

简要总结

The proposed study is to validate a new non-invasive imaging technique for evaluation of cardiac microciculation in coronary artery disease with a comparison with validated technique invasive, which is measure of index of myocardial resistance.

详细描述

Coronary microvascular dysfunction is closely associated with coronary artery disease, it is an independent risk factor and predicts future coronary events or clinically manifest disease up to 10 years later.

Index of microcirculatory resistance (IMR) is a validated method to Assessment of the Coronary Microcirculation but this is an invasive technique.

In this study, we use a new mathematic technique from homogeneity analysis to provide precise, objective, automated quantification of perfusion heterogeneity at stress with new camera CZT SPECT. We compare the results with those of the measurement of IMR.

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

  • Stable angina
  • Cadmium-zinc-telluride gamma camera SPECT
  • Coronarography

排除标准

  • Pregnant woman
  • Patient with terminal illness,
  • Terminal Renal failure
  • Allergy to iodine
  • Contraindications for adenosine: Asthmatic patients, Second- or third-degree AV block without a pacemaker or sick sinus syndrome, Systolic blood pressure less than 90mm Hg, Recent use of dipyridamole or dipyridamole-containing medications, Methyl xanthenes such as aminophylline caffeine or theobromine block the effect of adenosine and should be held for at least 12 hours prior to the test, Known hypersensitivity to adenosine, Unstable acute myocardial infarction or acute coronary syndrome

研究组 & 干预措施

a new non-invasive imaging technique

Experimental

a new non-invasive imaging technique for evaluation of cardiac microciculation in coronary artery disease

干预措施: a new non-invasive imaging technique (Procedure)

结局指标

主要结局

coronary microcirculation

时间窗: day 0 (inclusion)

IMR was measured with commercially available software (St Jude Medical Systems) and thermodilution technique on a non-ischemic artery SPECT. Injections of 3 mL of room-temperature saline were made down the coronary artery, and the resting mean transit time (Tmn) was measured. CFR was calculated as resting Tmn divided by hyperemic Tmn. FFR was calculated by the ratio of Pd/Pa at maximal hyperemia.IMR was defined as distal coronary pressure multiplied by the hyperemic mean transit time (mm Hg • seconds, or units \[U\]). Myocardial Heterogeneity Index (Hi) was measured by an automated analysis developed in our research unit. Hi was finally calculated from images SPECT using a Markovian analysis. For this study Hi is given by the equation: Hi = Σm \[1/(1+m)2\]Pd(m).

次要结局

  • scintigraphy(day 0 (inclusion))

研究者

发起方
University Hospital, Grenoble
申办方类型
Other
责任方
Sponsor

研究点 (2)

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