Rapid Stress/Rest Single-Day Tc-99m Sestamibi Myocardial SPECT
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 102
- 试验地点
- 1
- 主要终点
- Myocardial Perfusion SPECT Image Quality 12 Minutes
研究概览
简要总结
This protocol details a novel myocardial perfusion Single Photon Emission Computed Tomography (SPECT) protocol wherein patients receive a low-dose (6 mCi) of Tc-99m sestamibi during exercise or regadenoson pharmacologic stress and undergo a full-time SPECT acquisition processed with Wide Beam Reconstruction (WBR). Immediately thereafter patients receive a high-dose (30-35 mCi) of Tc-99m sestamibi at rest and undergo a half-time rest scan, also processed with WBR. All enrolled research subjects will undergo both the initial stress and subsequent rest scan.
The radiation exposure associated with this new stress/rest protocol is equivalent to that of the conventional rest/stress protocol presently in routine clinical uses at SLRHC.
Eventually, when and if this novel stress/rest protocol is adopted in routine clinical practice, patients with normal stress scans would receive only 6 mCi of Tc-99m sestamibi (331 mSv in men, 241 mSv in women) and spend only approximately one hour in the Nuclear Medicine Laboratory.
All patients presenting to the Nuclear Medicine Laboratory for evaluation of known or suspected coronary artery disease will be candidates for enrollment. Fifty patients undergoing treadmill exercise stress and 50 patients undergoing regadenoson pharmacologic stress will be enrolled. Pregnant and breast-feeding patients will not be eligible.
详细描述
Specific Aims:
To validate acceptable image quality and the stress/rest myocardial count density ratio (as defined below) of the Rapid Stress/Rest Protocol
Experimental Design and Methods:
Validation of the stress/rest myocardial count density ratio achieved using a standard rest/stress protocol incorporating a conventional 3:1 stress/rest Tc-99m radiopharmaceutical dose ratio.
Human subjects:
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
- •not pregnant
- •suspected coronary artery disease
排除标准
- •under 18 years of age
结局指标
主要结局
Myocardial Perfusion SPECT Image Quality 12 Minutes
时间窗: at 12 minutes
SPECT image quality realized using the stress/rest single-day protocol: 12- minute post-stress acquisitions If myocardial image quality is equivalent or superior to that encountered with standard myocardial perfusion SPECT performed using a standard low-dose rest/high-dose SPECT protocol and OSEM processing and if the rest/stress myocardial count density ratio is \> 3.5 the outcome of a particular patient is judged to be favorable (acceptable).If either image quality is "poor" or if the rest/stress count density ratio is less than 3.5, the outcome is judged unfavorable.
Myocardial Perfusion SPECT Image Quality 16 Minutes
时间窗: at 16 minutes
SPECT image quality realized using the stress/rest single-day protocol: 16- minute post-stress acquisitions If myocardial image quality is equivalent or superior to that encountered with standard myocardial perfusion SPECT performed using a standard low-dose rest/high-dose SPECT protocol and OSEM processing and if the rest/stress myocardial count density ratio is \> 3.5 the outcome of a particular patient is judged to be favorable (acceptable).If either image quality is "poor" or if the rest/stress count density ratio is less than 3.5, the outcome is judged unfavorable.
次要结局
- Rest/Stress Myocardial Count Density Ratio(immediately following SPECT image processing (1 hour after the test))