Real-Time Myocardial Perfusion Echocardiography in the ICU

Myocardial Perfusion Imaging Clinical Trial

Official title:

(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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03173716
• Other study ID #: 16-009331
• Status: Completed
• Phase: Phase 4
• Start date: September 28, 2017
• Est. completion date: December 31, 2019

Study information

• Verified date: September 2020
• Source: Mayo Clinic
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 24
• Est. completion date: December 31, 2019
• Est. primary completion date: December 31, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Myocardial Perfusion Imaging

Intervention

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

Locations

Country	Name	City	State
United States	Mayo Clinic	Rochester	Minnesota

Sponsors (2)

Lead Sponsor	Collaborator
Mayo Clinic	Lantheus Medical Imaging

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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

External Links

•   Mayo Clinic Clinical Trials