Lexi-Echo - a Rapid, Portable, Non-radiating Diagnostic Test for Myocardial Ischemia That is Accurate Relative to Simultaneously Obtained Nuclear SPECT MPI
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 380
- 试验地点
- 1
- 主要终点
- Determine the diagnostic accuracy of state-of-the-art echocardiography after regadenoson administration (Lexi-Echo) in the evaluation of myocardial ischemia (determined by the reference standard myocardial perfusion imaging SPECT).
研究概览
简要总结
This study is for people who have a SPECT scan (nuclear imaging of the blood flow to the heart muscle) ordered by their medical doctors. As part of the SPECT scan, they will have been given a drug called regadenoson to widen and expand the blood vessels bringing blood to the heart muscle. The SPECT pictures of the heart are taken about an hour after the regadenoson is put into an arm vein through an IV. In this study, additional echo pictures will be taken and compared to the SPECT pictures.
The aim of the study is to see if the echo pictures work as well as SPECT to measure the blood flow to the heart muscle.
详细描述
This is a single center, prospective, non-randomized, comparative, same-setting study of Lexiscan MPI SPECT versus state-of-the-art echocardiography. Lexiscan SPECT MPI will be performed per routine clinical protocol with Lexiscan administered as per package insert (0.4 mg in 5 ml IV push over 10 seconds followed by a 5 ml saline flush). Simultaneous echo/Doppler will be obtained immediately before (baseline), during and immediately post (peak vasodilation) using conventional techniques.
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 referred to a University of Arizona/Sarver Heart Center/University Medical Center stress imaging laboratory and scheduled to receive a regadenoson SPECT nuclear scan.
排除标准
- •Patients unable or unwilling to undergo the clinically necessary stress test or to provide informed consent.
研究组 & 干预措施
Lexi-Echo pilot
Appropriate patients at University of Arizona Medical Center stress imaging laboratory who have a routine regadenoson SPECT nuclear scan will have simultaneous cardiac echo images obtained.
干预措施: No intervention (Drug)
结局指标
主要结局
Determine the diagnostic accuracy of state-of-the-art echocardiography after regadenoson administration (Lexi-Echo) in the evaluation of myocardial ischemia (determined by the reference standard myocardial perfusion imaging SPECT).
时间窗: 10 minutes
次要结局
- Obtain short term (6 month) outcomes: hospitalization for ischemia or infarction, coronary angiographic (invasive or noninvasive) correlation when available for clinical indications, and mortality.(6 months)
- Perform a limited cost-analysis of the two diagnostic testing options(6 months)
- Obtain hemodynamic Doppler Echo variables to investigate the acute hemodynamic alterations during Lexiscan infusion.(10 minutes)
研究者
Aiden Abidov
Associate Professor of Medicine and Radiology
University of Arizona