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

This study has been withdrawn prior to enrollment.
(The study was withdrawn due to many implementation difficulties.)
Sponsor:
Collaborators:
Microvascular Therapeutics
Bnai Zion Medical Center, and Rappaport Faculty of Medicine Technion-Israel Institute of Technology Haifa, Israel.
VU University Medical Center Department of Cardiology Amsterdam, The Netherlands
Heart Institute (inCor) University of São Paulo Medical School São Paulo, Brazil
Information provided by (Responsible Party):
Thomas R. Porter, MD, University of Nebraska
ClinicalTrials.gov Identifier:
NCT00955136
First received: August 5, 2009
Last updated: June 26, 2014
Last verified: June 2014
  Purpose

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 Intervention
Acute Coronary Syndrome
Myocardial Infarction
Device: Use of intermittent high MI impulses during echocardiogram

Study Type: Interventional
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

Resource links provided by NLM:


Further study details as provided by University of Nebraska:

Primary Outcome Measures:
  • 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 ]

Enrollment: 0
Study Start Date: July 2012
Estimated Study Completion Date: April 2015
Estimated Primary Completion Date: April 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

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.

  Eligibility

Ages Eligible for Study:   30 Years and older
Genders Eligible for Study:   Both
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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 Department of Cardiology Amsterdam, The Netherlands
Heart Institute (inCor) University of São Paulo Medical School São Paulo, Brazil
Investigators
Principal Investigator: Thomas R Porter, MD University of Nebraska
  More Information

No publications provided

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
Study First Received: August 5, 2009
Last Updated: June 26, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by University of Nebraska:
ST elevated myocardial infarction
Acute coronary syndrome
MRX 801
Echocardiography

Additional relevant MeSH terms:
Acute Coronary Syndrome
Infarction
Myocardial Infarction
Syndrome
Angina Pectoris
Cardiovascular Diseases
Chest Pain
Disease
Heart Diseases
Ischemia
Myocardial Ischemia
Necrosis
Pain
Pathologic Processes
Signs and Symptoms
Vascular Diseases

ClinicalTrials.gov processed this record on October 21, 2014