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临床试验/NCT01137409
NCT01137409已完成不适用

Detecting Heart Disease Using First Pass Imaging With Gated SPECT Perfusion

Yale University1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2010年8月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
40
试验地点
1
主要终点
To determine if stress first pass imaging in conjunction with gated SPECT, with or with out low level exercise,will improve the sensitivity for detecting ischemic heart disease

研究概览

简要总结

The aim of this study is to determine if stress first pass imaging in conjunction with a nuclear scan will improve the sensitivity for detecting heart disease. This study will also test the usefulness of a nuclear medicine camera, CDLCAM One Pass Angiography system.

详细描述

In this clinical trial, patients with suspected or previously diagnosed coronary artery disease who are clinically referred for either a treadmill exercise stress/rest SPECT study or a vasodilatation stress/rest SPECT study will be considered for this protocol. The vasodilation study may be either adenosine or regadenosin. In addition to the stress study, a stress/rest echocardiography study and first pass image will also be obtained. The reason to include echocardiography is to provide an independent measurement of the ejection fraction during pharmacological stress for comparison to the ejection fraction from the first pass study and from the ECG-gated SPECT study performed at rest. This will evaluate the added value of calculation of stress left ventricular ejection fraction (LVEF) over gated SPECT resting EF. This information will also assist in evaluating LV dysfunction following induction of pharmacological stress Nuclear imaging compared with echocardiographic stress EF, established imaging modalities for assessment of coronary heart disease.

The study will include two ECHO imaging sessions and two SPECT imaging sessions.

Patients will undergo a resting first pass image during the administration 99mTc-tetrofosmin; and a resting ECHO study at an appropriate imaging time. The resting ECHO will also be used to assess patient imaging window quality and to optimize equipment settings for subsequent stress images. A rest gated-SPECT image will be acquired at the appropriate imaging time.

The patient will then undergo a standard vasodilation stress infusion. A first pass image will be obtained during the administration of 99mTc-tetrofosmin. An ECHO will be obtained prior to the completion of the infusion. A gated-SPECT study will then be performed at the appropriate imaging time.

Tetrofosmin ECG-gated SPECT Imaging:

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Years 至 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 未提供

排除标准

  • Patient consumed food/beverage/medication containing caffeine/methylxanthines up to 12 hours prior to infusion
  • Exacerbation of COPD, Asthma (actively wheezing)
  • Sinus node dysfunction in absence of pacemaker
  • Use of Aggrenox (ASA/Dipyridamole), Pentoxifylline (Trental) , or oral Dipyridamole (Persantine)
  • Atrial fibrillation
  • Pregnant/breast feeding
  • Non English speaking patients
  • Subject is allergic or intolerant to aminophylline, regadenoson
  • Subject has a history of known or suspected bronchospastic lung disease [e.g., asthma, wheezing, chronic obstructive pulmonary disease (COPD, etc.)]
  • Patients with first degree or second degree AV block

结局指标

主要结局

To determine if stress first pass imaging in conjunction with gated SPECT, with or with out low level exercise,will improve the sensitivity for detecting ischemic heart disease

时间窗: First pass imaging done in conjunction with SPECT study

First pass imaging will be done in conjunction with the clinically indicated SPECT study.

次要结局

  • To determine if first pass imaging provides a more reproducible approach for evaluation of both rest and stress global LV function over gated SPECT perfusion imaging compared with 3D echocardiography(Immediately following administration of regadenoson.)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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