Real-Time Myocardial Perfusion Echocardiography in the ICU

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

24 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-09-28

Study Completion Date

2019-12-31

Brief Summary

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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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Detailed Description

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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.

Conditions

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Myocardial Perfusion Imaging

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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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.

Group Type ACTIVE_COMPARATOR

Definity

Intervention Type PROCEDURE

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

Control Arm

Echocardiograms will be performed without the use of DEFINITY contrast/RTMPE.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Definity

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

Intervention Type PROCEDURE

Eligibility Criteria

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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