Utilization of Diagnostic Ultrasound in the Detection and Therapy of Acute Coronary Syndromes
Recruitment status was Not yet recruiting
The study will see if mechanical impulses delivered by an echocardiographic probe during a continuous infusion of Definity are capable of improving blood flow in smaller heart vessels in patients with acute coronary syndromes.
|Study Design:||Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
|Official Title:||Utilization of Diagnostic Ultrasound in the Detection and Therapy of Acute Coronary Syndromes|
- Improved microvascular recanalization and epicardial recanalization rates in STEMI as assessed by coronary angiography and recovery of regional microvascular perfusion and function in the post-infarction period. [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
|Study Start Date:||September 2009|
|Estimated Study Completion Date:||January 2010|
|Estimated Primary Completion Date:||December 2009 (Final data collection date for primary outcome measure)|
Experimental: High mechanical index impulses
Using the transthoracic three dimensional imaging probe, low mechanical index (MI) will examine wall motion. Intermittent high MI impulses will be administered over the microvasculature where there are wall motion abnormalities using an imaging plan that best aligns itself with the risk area.
One vial of Definity in 50cc of normal saline infused continuously in conjunction with the high MI impulses.
Pre-clinical studies have indicated that, during a continuous infusion of intravenous perfluorocarbon-containing microbubbles, the ultrasonic power delivered from a diagnostic ultrasound transducer is capable of restoring microcirculatory flow and improving epicardial recanalization rates following acute coronary thrombotic occlusions. Since both diagnostic ultrasound and intravenous infusions of microbubbles are a Class I indication to assess regional and global left ventricular function and risk area in patients with ST segment elevation myocardial infarction (STEMI), this pilot study will examine whether diagnostic assessments of left ventricular function and risk area size impacts epicardial recanalization rates and infarct size in STEMI.
The aim of this study is to test whether guided high mechanical index impulses from a diagnostic transducer during a continuous infusion of intravenous microbubbles are capable of improving microvascular recanalization and epicardial recanalization rates in STEMI, as assessed by coronary angiography, and recovery of regional microvascular perfusion and function in the post-infarction period.
|Contact: Thomas R Porter, MDfirstname.lastname@example.org|
|Contact: Mary M Adolphson, RNemail@example.com|
|United States, Nebraska|
|University of Nebraska Medical Center||Not yet recruiting|
|Omaha, Nebraska, United States, 68105|
|Principal Investigator: Thomas R Porter, MD|
|Principal Investigator:||Thomas R Porter, MD||University of Nebraska|