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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

Status
Completed
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03173716
Enrollment
24
Registered
2017-06-02
Start date
2017-09-28
Completion date
2019-12-31
Last updated
2020-09-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Myocardial Perfusion Imaging

Keywords

DEFINITY contrast

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.

Interventions

PROCEDUREDefinity

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

Sponsors

Lantheus Medical Imaging
CollaboratorINDUSTRY
Mayo Clinic
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Change from Baseline Diagnostic Confidence Post-Echocardiographythrough study completion, anticipated 1 year5-point Likert scale will be used to assess providers' diagnostic confidence

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026