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Clinical Trials/NCT03173716
NCT03173716CompletedPhase 4

(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 sites in 1 country24 target enrollmentStarted: September 28, 2017Last updated:
Conditions

Trial Snapshot

Phase
Phase 4
Status
Completed
Enrollment
24
Locations
2
Primary Endpoint
Change from Baseline Diagnostic Confidence Post-Echocardiography

Study Overview

Brief Summary

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.

Detailed Description

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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Diagnostic
Masking
None

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

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

Outcomes

Primary Outcomes

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

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Patricia A. Pellikka

Principal Investigator

Mayo Clinic

Study Sites (2)

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