Reducing Radioisotope Dose in Regadenoson SPECT Myocardial Perfusion Imaging: Comparison of Half-Dose Scans Using a Novel Solid-State-Detector Dedicated Cardiac Camera to Full Dose Scans Acquired On Standard Equipment
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 74
- 试验地点
- 2
- 主要终点
- Image quality of the half-dose CZT versus full dose scans
研究概览
简要总结
This is a pilot study to see whether cardiac imaging can be performed using half the standard dose of radioisotope.
详细描述
The aim of this study is to compare the image quality of the half radioisotope dose scans obtained using a CZT (cadmium zinc telluride) camera with scans acquired using a standard of care imaging protocol/radioisotope dose performed on a traditional (conventional) camera.
The proposed strategy of a half dose/extended time protocol with the CZT camera should yield a similar count activity and consequently image quality equivalent to that detected by a conventional SPECT system.
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 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •≥ 18 years of age and referred for a clinically-indicated stress SPECT MPI study
- •suspected or known coronary artery disease
- •written informed consent
排除标准
- •Evidence of a normal baseline scan after at least 50% of the protocol acquired baseline scans have been interpreted as being normal
- •Participation in another investigational study within the preceding month
- •Pregnant and/or breast-feeding female
- •ECG evidence of left bundle branch block or paced rhythm
- •Evidence of non-ischemic cardiomyopathy
- •Presence of hypertrophic cardiomyopathy and/or severe valvular heart disease
- •Severe claustrophobia or inability to lie flat for 20 minutes (the anticipated amount of time to complete the procedure)
- •Known allergy to technetium-99m
- •Potential contraindications to regadenoson use, due to severe lung disease; severe bradycardia (heart rate < 40 beats/min); second- or third degree atrioventricular heart block; sick sinus syndrome; long QT syndrome; severe hypotension; or decompensated heart failure.
研究组 & 干预措施
Half-dose isotope for NuclearStressTest
Intervention is Nuclear stress test of the heart. Single-arm of this study "Half-dose of isotope for Nuclear stress test" is group of study subjects who will do Research Nuclear stress test with half-dose of isotope that normally used for routine Nuclear stress test. Isotope is the tracer CZT (cadmium zinc telluride) that used for Nuclear stress test routinely to see the function of arteries of the heart. Patients with suspected Coronary Artery Disease who meet entry criteria undergo a research nuclear stress test using a decreased dose of isotope, using a new camera.
干预措施: Half-dose isotope for NuclearStressTest (Other)
结局指标
主要结局
Image quality of the half-dose CZT versus full dose scans
时间窗: 1 Week
次要结局
- Total radiation dose/exposure of the half-dose CZT vs. full dose scans(1 Week)
- Total myocardial count activity and count rates obtained during each scan(1 Week)
- Agreement between the half-dose CZT vs. full dose scans on the presence and extent of fixed or reversible defects on a per-patient and vessel basis(1 Week)
- Agreement between the half-dose vs. full dose scans on gated data such as EF, left ventricular (LV) end-diastolic volume, LV end-systolic volume(1 Week)
研究者
S.M.Chang, MD
Sponsor-Investigator/Principal Investigator
The Methodist Hospital Research Institute