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临床试验/NCT03173716
NCT03173716已完成4 期

(RTMPE in the ICU) The Impact of Real-Time Myocardial Perfusion Echocardiography on Diagnostic Confidence and Subsequent Management of Myocardial Ischemia in the Intensive Care Unit

Mayo Clinic2 个研究点 分布在 1 个国家目标入组 24 人开始时间: 2017年9月28日最近更新:
适应症

试验速览

阶段
4 期
状态
已完成
发起方
Mayo Clinic
入组人数
24
试验地点
2
主要终点
Change from Baseline Diagnostic Confidence Post-Echocardiography

研究概览

简要总结

This study is being done to find out if and how much the use of RTMPE improves a provider's confidence in the diagnosis they assign. This is important because the use of RTMPE may decrease the need for any additional invasive testing.

详细描述

The finding of elevated troponins and regional wall motion abnormalities on echocardiography in the absence of other signs of acute coronary syndrome among the intensive care population creates a diagnostic challenge for evaluation. Sometimes these ill patients undergo invasive coronary angiography to rule out acute thrombosis. Real-Time Myocardial Perfusion Echocardiography (RTMPE) is a safe and accurate imaging modality to assess perfusion and can be performed in the resting state at the bedside in the intensive care unit (ICU) to help stratify the likelihood intracoronary thrombosis as the etiology for abnormal troponins and/or echocardiography. The primary aim of this study is to evaluate the impact of RTMPE on providers' diagnostic confidence using a 5-point Likert scale for patients that receive a standard transthoracic echocardiogram (TTE) compared to patients that receive RTMPE. The RTMPE to assess perfusion will be added to the standard transthoracic echocardiogram in approximately 24 patients undergoing evaluation of myocardial ischemia in medical or surgical ICUs. The caring provider will complete a web-based survey regarding their confidence in the diagnosis prior to and after the study in both groups. The images will be interpreted by an experienced cardiologist and results will be made available in the medical record. The difference in diagnostic confidence scores will be analyzed using the Wilcoxon signed-rank test. The secondary aims are to assess the management and outcomes in both groups.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
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

入选标准

  • Adults age ≥ 18 years
  • Located in a designated ICU
  • TTE ordered by the primary care team
  • Significant delta in troponin trend
  • Concern for myocardial ischemia
  • Women of child-bearing potential must have a clinical negative pregnancy test result
  • Experienced sonographer available to complete RTMPE portion of the exam
  • Provider willing to complete the study survey

排除标准

  • Adults < 18 years
  • Contraindication to echo contrast administration
  • Location other than an ICU
  • No significant delta in troponin trend

结局指标

主要结局

Change from Baseline Diagnostic Confidence Post-Echocardiography

时间窗: through study completion, anticipated 1 year

5-point Likert scale will be used to assess providers' diagnostic confidence

次要结局

未报告次要终点

研究者

发起方
Mayo Clinic
申办方类型
Other
责任方
Principal Investigator
主要研究者

Patricia A. Pellikka

Principal Investigator

Mayo Clinic

研究点 (2)

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