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
1 other identifier
interventional
24
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_4
Started Sep 2017
Typical duration for phase_4
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 23, 2017
CompletedFirst Posted
Study publicly available on registry
June 2, 2017
CompletedStudy Start
First participant enrolled
September 28, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
December 31, 2019
CompletedSeptember 9, 2020
September 1, 2020
2.3 years
May 23, 2017
September 5, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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
Study Arms (2)
Intervention Group
ACTIVE COMPARATORDEFINITY 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.
Control Arm
NO INTERVENTIONEchocardiograms will be performed without the use of DEFINITY contrast/RTMPE.
Interventions
Real-Time Myocardial Perfusion Echocardiography (RTMPE) will be performed as opposed to the standard echocardiogram (TTE) of the control arm
Eligibility Criteria
You may qualify if:
- Adults age ≥ 18 years
- Located in a designated ICU
- TTE ordered by the primary care team
- Significant delta in troponin trend
- Concern for myocardial ischemia
- Women of child-bearing potential must have a clinical negative pregnancy test result
- Experienced sonographer available to complete RTMPE portion of the exam
- Provider willing to complete the study survey
You may not qualify if:
- Adults \< 18 years
- Contraindication to echo contrast administration
- Location other than an ICU
- No significant delta in troponin trend
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Mayo Cliniclead
- Lantheus Medical Imagingcollaborator
Study Sites (1)
Mayo Clinic
Rochester, Minnesota, 55905, United States
Related Links
MeSH Terms
Interventions
Study Officials
- PRINCIPAL INVESTIGATOR
Patricia A. Pellikka
Mayo Clinic
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- DIAGNOSTIC
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
May 23, 2017
First Posted
June 2, 2017
Study Start
September 28, 2017
Primary Completion
December 31, 2019
Study Completion
December 31, 2019
Last Updated
September 9, 2020
Record last verified: 2020-09