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

Myocardial Infarction Clinical Trial

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT00955136
• Other study ID #: 0286-09-FB
• Status: Withdrawn
• Phase: N/A
• Start date: July 2009
• Est. completion date: January 25, 2010

Study information

• Verified date: August 2023
• Source: University of Nebraska
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: January 25, 2010
• Est. primary completion date: January 25, 2010
• Accepts healthy volunteers: No
• Gender: All
• Age group: 30 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Acute Coronary Syndrome
• Infarction
• Myocardial Infarction
• Syndrome

Intervention

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.

Locations

Country	Name	City	State
n/a

Sponsors (6)

Lead Sponsor	Collaborator
University of Nebraska	Amsterdam University Medical Centers (UMC), Location Academic Medical Center (AMC), Bnai Zion Medical Center, InCor Heart Institute, Microvascular Therapeutics, LLC, The Ruth and Bruce Rappaport Faculty of Medicine

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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