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临床试验/NCT01387152
NCT01387152已完成不适用

Prognosis of Very Low Dose Stress First Myocardial Perfusion SPECT in Patients With Chest Pain Using an Alcyone Camera

Columbia University1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2011年11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
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

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

申办方类型
Other
责任方
Principal Investigator
主要研究者

Andrew J. Einstein, MD, PhD

Associate Professor of Medicine, Radiology

Columbia University

研究点 (1)

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