Real-Time Myocardial Perfusion Echocardiography in the ICU

(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

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.

Study Overview

• Status: Completed
• Conditions: Myocardial Perfusion Imaging
• Intervention / Treatment: Procedure: Definity

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 Type: Interventional
• Enrollment (Actual): 24
• Phase: Phase 4

Contacts and Locations

Study Locations

• United States
  • Minnesota
    • Rochester, Minnesota, United States, 55905
      • Mayo Clinic

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

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

Exclusion Criteria:

1. Adults < 18 years
2. Contraindication to echo contrast administration
3. Location other than an ICU
4. No significant delta in troponin trend

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Intervention Group; DEFINITY contrast will be prepared according to package insert instructions. A dose of 1.5 mL activated DEFINITY diluted in 28.5 of preservative free saline to constitute a total volume of 30 mL will be infused at a rate of 90-120 mL/hr (1.5-2.0 mL/min). RTMPE will be performed.	Procedure: Definity; Real-Time Myocardial Perfusion Echocardiography (RTMPE) will be performed as opposed to the standard echocardiogram (TTE) of the control arm
No Intervention: Control Arm; Echocardiograms will be performed without the use of DEFINITY contrast/RTMPE.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change from Baseline Diagnostic Confidence Post-Echocardiography	5-point Likert scale will be used to assess providers' diagnostic confidence	through study completion, anticipated 1 year

Collaborators and Investigators

• Sponsor: Mayo Clinic
• Collaborators: Lantheus Medical Imaging
• Investigators: Principal Investigator: Patricia A. Pellikka, Mayo Clinic

Publications and helpful links

Helpful Links

• Mayo Clinic Clinical Trials

Study record dates

Study Major Dates

• Study Start (Actual): September 28, 2017
• Primary Completion (Actual): December 31, 2019
• Study Completion (Actual): December 31, 2019

Study Registration Dates

• First Submitted: May 23, 2017
• First Submitted That Met QC Criteria: June 1, 2017
• First Posted (Actual): June 2, 2017

Study Record Updates

• Last Update Posted (Actual): September 9, 2020
• Last Update Submitted That Met QC Criteria: September 5, 2020
• Last Verified: September 1, 2020

More Information

Terms related to this study

• Keywords: DEFINITY contrast
• Other Study ID Numbers: 16-009331

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: Yes