Real-Time Myocardial Perfusion Echocardiography in the ICU

Mayo Clinic

Status and phase: Completed; Phase 4

Conditions: Myocardial Perfusion Imaging

Treatments: Procedure: Definity

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT03173716

16-009331

Details and patient eligibility

About

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.

Full 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.

Enrollment: 24 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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24 participants in 2 patient groups

Intervention Group

Active Comparator group

Description:

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.

Treatment:

Procedure: Definity

Control Arm

No Intervention group

Description:

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