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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified August 2009 by University of Nebraska.
Recruitment status was  Not yet recruiting
Sponsor:
Collaborators:
Lantheus Medical Imaging
Tel-Aviv Sourasky Medical Center
Information provided by:
University of Nebraska
ClinicalTrials.gov Identifier:
NCT00955136
First received: August 5, 2009
Last updated: August 6, 2009
Last verified: August 2009
  Purpose

The study will see if mechanical impulses delivered by an echocardiographic probe during a continuous infusion of Definity are capable of improving blood flow in smaller heart vessels in patients with acute coronary syndromes.


Condition Intervention
Acute Coronary Syndrome
Myocardial Infarction
Drug: Definity

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 ]

Estimated Enrollment: 10
Study Start Date: September 2009
Estimated Study Completion Date: January 2010
Estimated Primary Completion Date: December 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: High mechanical index impulses
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.
Drug: Definity
One vial of Definity in 50cc of normal saline infused continuously in conjunction with the high MI 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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00955136

Contacts
Contact: Thomas R Porter, MD 402-599-7977 trporter@unmc.edu
Contact: Mary M Adolphson, RN 402-559-8084 madolphson@unmc.edu

Locations
United States, Nebraska
University of Nebraska Medical Center Not yet recruiting
Omaha, Nebraska, United States, 68105
Principal Investigator: Thomas R Porter, MD         
Sponsors and Collaborators
University of Nebraska
Lantheus Medical Imaging
Tel-Aviv Sourasky Medical Center
Investigators
Principal Investigator: Thomas R Porter, MD University of Nebraska
  More Information

No publications provided

Responsible Party: Thomas R, Porter, MD, University of Nebraska Medical Center
ClinicalTrials.gov Identifier: NCT00955136     History of Changes
Other Study ID Numbers: 286-09-FB
Study First Received: August 5, 2009
Last Updated: August 6, 2009
Health Authority: United States: Institutional Review Board

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

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

ClinicalTrials.gov processed this record on April 16, 2014