Utilization of Diagnostic Ultrasound in the Detection and Therapy of Acute Coronary Syndromes
Recruitment status was Not yet recruiting
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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 |
- 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 |
Inclusion Criteria:
- Male or female, age ≥ 30 years.
- Chest Pain occurring lasting less than six hours from onset, and EKG evidence of an acute ST segment elevation myocardial infarction.
- Arrival in the Emergency Department with above inclusion criteria between 7 am and 7pm.
Exclusion Criteria:
- Known or suspected hypersensitivity to ultrasound contrast agent used for the study.
- Complicated hemodynamic instability (i.e., NYHA Class IV heart failure, unstable angina at rest despite medical therapy).
- Life expectancy of less than two months or terminally ill.
- Heart transplant recipient, hypertrophic cardiomyopathy, severe valvular disease, acute myo- or pericarditis.
- Contraindication to Heart Catheterization
- Known bleeding diathesis or contraindication to glycoprotein 2b/3a inhibitors or aspirin.
Contacts and Locations| Contact: Thomas R Porter, MD | 402-599-7977 | trporter@unmc.edu |
| Contact: Mary M Adolphson, RN | 402-559-8084 | madolphson@unmc.edu |
| United States, Nebraska | |
| University of Nebraska Medical Center | Not yet recruiting |
| Omaha, Nebraska, United States, 68105 | |
| Principal Investigator: Thomas R Porter, MD | |
| 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 May 22, 2013