Real-Time Myocardial Perfusion Echocardiography in the ICU

Phase 4

Completed

• Conditions: Myocardial Perfusion Imaging
• Interventions: Procedure: Definity

• Registration Number: NCT03173716
• Lead Sponsor: Mayo Clinic

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 Timeline

• Study First Submitted: 2017-05-23
• Study First Submitted QC: 2017-06-01
• Study First Posted: 2017-06-02
• Study Start: 2017-09-28
• Primary Completion: 2019-12-31
• Study Completion: 2019-12-31
• Status Verified: 2020-09
• Last Update Submitted: 2020-09-05
• Last Update Posted: 2020-09-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 24

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Intervention Group	Definity	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.

Primary Outcome Measures

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

Trial Locations

Locations (1)

Mayo Clinic; 🇺🇸 Rochester, Minnesota, United States