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

NCT ID: NCT00955136

Last Updated: 2023-08-14

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: NA
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-07-31
• Study Completion Date: 2010-01-25

Brief 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.

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.

Conditions

Acute Coronary Syndrome; Myocardial Infarction

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Use of intermittent high MI impulses during echocardiogram

Intervention Type: DEVICE

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.

Interventions

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.

Intervention Type: DEVICE

Eligibility Criteria

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.

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.

• Minimum Eligible Age: 30 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Microvascular Therapeutics, LLC

INDUSTRY

Sponsor Role: collaborator

The Ruth and Bruce Rappaport Faculty of Medicine

UNKNOWN

Sponsor Role: collaborator

Amsterdam University Medical Centers (UMC), Location Academic Medical Center (AMC)

OTHER

Sponsor Role: collaborator

InCor Heart Institute

OTHER

Sponsor Role: collaborator

Bnai Zion Medical Center

OTHER_GOV

Sponsor Role: collaborator

University of Nebraska

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Thomas R Porter, MD

Role: PRINCIPAL_INVESTIGATOR

University of Nebraska

Other Identifiers

0286-09-FB

Identifier Type: -

Identifier Source: org_study_id