Prognosis of Very Low Dose Stress First Myocardial Perfusion SPECT in Patients With Chest Pain Using an Alcyone Camera
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Percentage of patients free of composite endpoint
研究概览
简要总结
Nuclear stress testing evaluates whether the heart receives enough blood, by injection of a nuclear isotope during a stress on the heart that permits taking pictures of the heart muscle. A low-radiation-dose protocol for nuclear stress testing involves injecting less of the nuclear isotope than standard protocols, by utilizing a new, more efficient camera (called an Alcyone camera) which could decrease radiation dose to patients while still providing excellent clinical information. Subjects will undergo imaging under the Alcyone camera after undergoing stress testing with exercise or a standard medication simulating exercise, and then at rest if needed. Subjects will have follow-up to measure events occurring after the test, such as death, heart attack, unstable angina, repeat emergency department visit for chest pain evaluation, or repeat imaging needed to evaluation for coronary artery disease. Radiation doses and quality of the images from the imaging with the new protocol will be recorded to compare to those used in standard nuclear imaging protocols. The primary study hypothesis is that greater than 90% of patients who have a normal very low dose stress first myocardial perfusion scintigraphy (MPS) will be free at 3 months after study of death, nonfatal myocardial infarction, unstable angina, and repeat emergency department visit for chest pain evaluation or repeat anatomical or functional cardiac imaging.
详细描述
See brief summary above.
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 —(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients presenting with chest pain but normal or nondiagnostic electrocardiograms and at least 3 negative troponin levels taken 4 or more hours apart.
- •Age greater than 18 years.
- •Written informed consent is obtained by a study investigator.
排除标准
- •Previous Myocardial perfusion scintigraphy (MPS) with evidence of scar
- •Previous MPS with evidence of ischemia and no subsequent revascularization
- •Known dilated left ventricle
- •Known cardiomyopathy
- •High pre-test probability of a perfusion defect on MPS
- •Body mass index greater than 35
- •Prisoner status
结局指标
主要结局
Percentage of patients free of composite endpoint
时间窗: 3 months after MPS and hospital discharge (an expected average of 12 hours after MPS)
Composite endpoint consists of: * death * non-fatal myocardial infarction * unstable angina * repeat emergency department visit for chest pain evaluation,or repeat anatomical or functional cardiac imaging
次要结局
- Duration of stress test(Up to 12 months after MPS and hospital discharge (an expected average of 12 hours after MPS))
- Image quality on a 5 point scale(Up to 12 months after MPS and hospital discharge (an expected average of 12 hours after MPS))
- Average effective dose received by patients for whom stress-only MPS is performed.(Up to 12 months after MPS and hospital discharge (an expected average of 12 hours after MPS))
- Percentage of patients for whom rest imaging is needed.(12 months after MPS and hospital discharge (an expected average of 12 hours after MPS))
- Average effective dose of radiation received by all patients.(Up to 12 months after MPS and hospital discharge (an expected average of 12 hours after MPS))
- Duration of hospitalization(Up to 12 months after MPS and hospital discharge (an expected average of 12 hours after MPS))
研究者
Andrew J. Einstein, MD, PhD
Associate Professor of Medicine, Radiology
Columbia University
