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This study has been withdrawn prior to enrollment.
(The study was withdrawn due to many implementation difficulties.)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

August 5, 2009
June 26, 2014
July 2012
April 2013   (final data collection date for primary outcome measure)
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 ]
Same as current
Complete list of historical versions of study NCT00955136 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Utilization of Diagnostic Ultrasound in the Detection and Therapy of Acute Coronary Syndromes
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.

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.

Interventional
Not Provided
Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
  • Acute Coronary Syndrome
  • Myocardial Infarction
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.
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.
Intervention: Device: Use of intermittent high MI impulses during echocardiogram
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Withdrawn
0
April 2015
April 2013   (final data collection date for primary outcome measure)

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.
Both
30 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00955136
286-09-FB
No
Thomas R. Porter, MD, University of Nebraska
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
Principal Investigator: Thomas R Porter, MD University of Nebraska
University of Nebraska
June 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP