Determination of Left Ventricular Ejection Fraction Using Cardiac Angioscintigraphy: Comparison Between Measurements Obtained With Conventional Planar Scintigraphy (E-CAM Camera) and Tomoscintigraphy Recorded by a CZT Semiconductor Camera (D-SPECT)
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Comparison of measurement of LVEF with conventional camera and semiconductor camera analyzed by two different person
研究概览
简要总结
The purpose is to determine whether measurements of left ventricular ejection fraction (LVEF) obtained with angiographies recorded by conventional Anger camera or D-SPECT camera are equivalent.
Secondary purposes are:
- To evaluate the influence of cardiac activity recorded by D-SPECT camera on equivalences defined in primary purpose
- To evaluate the influence of the indication for the examination with a distinct analysis of a group having the examination for a known or suspected cardiomyopathy (LVEF often abnormally low) and a group having the examination for a chemotherapy supervision with heart initially considered healthy (LVEF often normal).
详细描述
Cardiac angioscintigraphy is an examination for a simple, precise and reproducible measurement of left ventricular ejection fraction (LVEF). It needs injection of 99mTc labeled albumin or red cells and unfortunately injected activities must be relatively considerable (≈ 900 MBq) for image recording times shorter than 10 minutes. This examination is thus quite irradiant (10 mSv) but this inconvenient could be eliminated with new semiconductor cameras.
These new cameras allow a better image quality than conventional Anger cameras (better spatial resolution and energy) and their detection sensitivity is almost 10 times higher. However, these new cameras can record only 3D images whereas with conventional cameras angioscintigraphy is usually performed in bidimensional way with a possible higher precision and reproducibility of LVEF measurement.
In this study, patients needing the routine examination for LVEF measurements will undergo the conventional examination followed by examination with semiconductor camera (without supplementary injection).
If LVEF measurement with semiconductor camera will be as precise and reproducible as with conventional camera, angioscintigraphy could be performed with these new cameras with a lower body irradiation of patients.
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
- 否
入选标准
- •Patients present in Nuclear Medicine department for measurement of LVEF by cardiac angioscintigraphy for known or suspected cardiomyopathy or for a chemotherapy supervision with heart initially considered healthy
- •Without guardianship, signed informed consent
- •Not in life-and-death emergency and with a stable clinical state
- •Affiliated to social security
- •Preliminary medical examination
排除标准
- •Patients having rhythm disorders (atrial or ventricular extrasystoles in more than 20% cardiac cycles, atrial fibrillation)
- •Incapable to stay in strict decubitus position during image recording times
- •Pregnant or breastfeeding women
研究组 & 干预措施
Myocardial angioscintigraphy
干预措施: stannous pyrophosphate (Drug)
Myocardial angioscintigraphy
干预措施: Technetium-99m (Drug)
Myocardial angioscintigraphy
干预措施: E-CAM Camera (Device)
Myocardial angioscintigraphy
干预措施: CZT Semiconductor Camera (D-SPECT) (Device)
结局指标
主要结局
Comparison of measurement of LVEF with conventional camera and semiconductor camera analyzed by two different person
时间窗: day 0
次要结局
- Comparison of measurements of LVEF with conventional camera and semiconductor camera in group of patients under LVEF supervision for chemotherapy(day 0)
- Measurements of LVEF with cardiac activity recorded by D-SPECT camera artificially diminished of 25%(day 0)
- Measurements of LVEF with cardiac activity recorded by D-SPECT camera artificially diminished of 75%(day 0)
- Comparison of measurements of LVEF with conventional camera and semiconductor camera in group of patients having cardiomyopathies(day 0)
- Measurements of LVEF with cardiac activity recorded by D-SPECT camera artificially diminished of 50%(day 0)