Utilization of Diagnostic Ultrasound in the Detection and Therapy of Acute Coronary Syndromes

The study will see if mechanical impulses delivered by an echocardiographic probe during a continuous infusion of MRX 801 are capable of improving blood flow in smaller heart vessels in patients with acute coronary syndromes.

Study Overview

• Status: Withdrawn
• Conditions: Myocardial Infarction; Acute Coronary Syndrome
• Intervention / Treatment: Device: Use of intermittent high MI impulses during echocardiogram

Detailed Description

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.

• Study Type: Interventional
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Nebraska
    • Omaha, Nebraska, United States, 68105
      • University of Nebraska Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 30 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. Male or female, age ≥ 30 years.
2. Chest Pain occurring lasting less than six hours from onset, and EKG evidence of an acute ST segment elevation myocardial infarction.
3. Arrival in the Emergency Department with above inclusion criteria between 7 am and 7pm.

Exclusion Criteria:

1. Known or suspected hypersensitivity to ultrasound contrast agent used for the study.
2. Complicated hemodynamic instability (i.e., NYHA Class IV heart failure, unstable angina at rest despite medical therapy).
3. Life expectancy of less than two months or terminally ill.
4. Heart transplant recipient, hypertrophic cardiomyopathy, severe valvular disease, acute myo- or pericarditis.
5. Contraindication to Heart Catheterization
6. Known bleeding diathesis or contraindication to glycoprotein 2b/3a inhibitors or aspirin.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: High MI impulses, myocardial infarction, echocardiography; 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 MRX 801 to be infused intravenously during echocardiography with high mechanical index impulses.

Device: Use of intermittent high MI impulses during echocardiogram; 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 MRX 801 to be infused intravenously during echocardiography with high mechanical index impulses.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	6 weeks

Collaborators and Investigators

• Sponsor: University of Nebraska
• Collaborators: Bnai Zion Medical Center; InCor Heart Institute; Microvascular Therapeutics, LLC; Amsterdam University Medical Centers (UMC), Location Academic Medical Center (AMC); The Ruth and Bruce Rappaport Faculty of Medicine
• Investigators: Principal Investigator: Thomas R Porter, MD, University of Nebraska

Study record dates

Study Major Dates

• Study Start (Estimated): July 1, 2009
• Primary Completion (Actual): January 25, 2010
• Study Completion (Actual): January 25, 2010

Study Registration Dates

• First Submitted: August 5, 2009
• First Submitted That Met QC Criteria: August 6, 2009
• First Posted (Estimated): August 7, 2009

Study Record Updates

• Last Update Posted (Actual): August 14, 2023
• Last Update Submitted That Met QC Criteria: August 10, 2023
• Last Verified: August 1, 2023

More Information

Terms related to this study

• Keywords: Acute coronary syndrome; Echocardiography; ST elevated myocardial infarction; MRX 801
• Additional Relevant MeSH Terms: Ischemia; Pathologic Processes; Necrosis; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Disease; Myocardial Infarction; Infarction; Syndrome; Acute Coronary Syndrome
• Other Study ID Numbers: 0286-09-FB