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

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ClinicalTrials.gov Identifier: NCT00955136
Recruitment Status : Withdrawn (The study was withdrawn due to many implementation difficulties.)
First Posted : August 7, 2009
Last Update Posted : June 30, 2014
Sponsor:
Collaborators:
Microvascular Therapeutics
Bnai Zion Medical Center, and Rappaport Faculty of Medicine Technion-Israel Institute of Technology Haifa, Israel.
VU University Medical Center
InCor Heart Institute
Information provided by (Responsible Party):
Thomas R. Porter, MD, University of Nebraska

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.

Condition or disease Intervention/treatment Phase
Acute Coronary Syndrome Myocardial Infarction Device: Use of intermittent high MI impulses during echocardiogram Not Applicable

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  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Utilization of Diagnostic Ultrasound in the Detection and Therapy of Acute Coronary Syndromes
Study Start Date : July 2012
Estimated Primary Completion Date : April 2013
Estimated Study Completion Date : April 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Attack
U.S. FDA Resources

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.



Primary Outcome Measures :
  1. 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 ]


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Ages Eligible for Study:   30 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
  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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00955136


Locations
United States, Nebraska
University of Nebraska Medical Center
Omaha, Nebraska, United States, 68105
Sponsors and Collaborators
University of Nebraska
Microvascular Therapeutics
Bnai Zion Medical Center, and Rappaport Faculty of Medicine Technion-Israel Institute of Technology Haifa, Israel.
VU University Medical Center
InCor Heart Institute
Investigators
Principal Investigator: Thomas R Porter, MD University of Nebraska

Responsible Party: Thomas R. Porter, MD, Principal Investigator, University of Nebraska
ClinicalTrials.gov Identifier: NCT00955136     History of Changes
Other Study ID Numbers: 286-09-FB
First Posted: August 7, 2009    Key Record Dates
Last Update Posted: June 30, 2014
Last Verified: June 2014

Keywords provided by Thomas R. Porter, MD, University of Nebraska:
ST elevated myocardial infarction
Acute coronary syndrome
MRX 801
Echocardiography

Additional relevant MeSH terms:
Syndrome
Infarction
Myocardial Infarction
Acute Coronary Syndrome
Disease
Pathologic Processes
Ischemia
Necrosis
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases