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OpenTrials
Completed

NCT Number: NCT03173716

Real-Time Myocardial Perfusion Echocardiography in the ICU

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Mayo Clinic

Rochester, Minnesota, 55905, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

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

Treatment and study plan

Definity

Procedure

Real-Time Myocardial Perfusion Echocardiography (RTMPE) will be performed as opposed to the standard echocardiogram (TTE) of the control arm

Primary outcomes

  1. Change from Baseline Diagnostic Confidence Post-Echocardiography

    Time frame: through study completion, anticipated 1 year

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

Sponsors and collaborators

Lead sponsor

Mayo Clinic

Other

Collaborators

  • Lantheus Medical Imaging

Registry information

Official study title

(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

Important dates

Study start
2017
Primary completion
2019
Study completion
2019
First posted
Jun 2, 2017
Registry last updated
Sep 9, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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