Microvascular Reperfusion Utilizing Sonothrombolysis in Acute Myocardial Infarction (MRUSMI TRIAL) (MRUSMI)
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|ClinicalTrials.gov Identifier: NCT02170103|
Recruitment Status : Unknown
Verified June 2014 by Thomas R. Porter, MD, University of Nebraska.
Recruitment status was: Recruiting
First Posted : June 23, 2014
Last Update Posted : June 23, 2014
|Condition or disease||Intervention/treatment||Phase|
|STEMI Chest Pain,||Procedure: percutaneous intervention (PCI) Drug: Microbubbles Procedure: Ultrasound||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||250 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Microvascular Reperfusion Utilizing Sonothrombolysis in Acute Myocardial Infarction (MRUSMI TRIAL)|
|Study Start Date :||May 2014|
|Estimated Primary Completion Date :||July 2015|
Experimental: Ultrasound and microbubbles
Patients who provide emergent consent will be randomized to either conventional therapy for a heart attack, or conventional therapy and ultrasound with microbubbles. The ultrasound will be applied both before and after emergent heart catheterization, in order to break up the blood clots that are not only in the artery supplying the heart muscle, but also in the small branches (capillaries) that are fed by this artery.
Procedure: percutaneous intervention (PCI)
The agents will be divided into two separate doses (two vials per study), and mixed with approximately 29 milliliters of saline (approximately a 2.0-4.0% infusion). The first dilution will be administered pre PCI therapy, and the second dilution infused immediately post PCI. Since Optison is less stable in saline, an alternative approach will be to give the Optison as intermittent 0.1 milliliter boluses followed by 3-5 saline flushes over 10 seconds. The entire duration of each treatment before PCI will be up to 30 minutes depending on time constraints in getting to the catheterization laboratory, while the duration of treatment immediately after PCI will be 30 minutes.
Intermittent high MI (Mechanical Index) impulses (0.8-1.4 MI; Frequency 1.0-1.7 MHz;pulse duration 4-44 microseconds) will be administered over the microvasculature where there are wall motion abnormalities and a perfusion defect using an imaging plane that best aligns itself with the risk area
Standard of care
Emergent PCI/antithrombotic/antiplatelet therapy with Echocardiogram to assess LVEF (Left Ventricular Ejection Fraction) and Aspirin, Plavix, or Direct Thrombin Inhibitor.
Procedure: percutaneous intervention (PCI)
- Six month event free survival (EFS) [ Time Frame: 6 months ]The time from the start of treatment to first cardiac event or death as a first event. Cardiac events include, congestive heart failure, life threatening arrhythmias, and need for prophylactic defibrillator (primary and secondary).
- Myocardial salvageability index [ Time Frame: Prior to hospital discharge (48-72 hours) ]The difference between extent of delayed enhancement by Gd MRI and the T2 weighted double or triple inversion spin echo assessment of risk area (defined above).
- Frequency of left ventricular remodeling [ Time Frame: 6 month follow-up ]Defined as a 20% increase in end diastolic volume at the six month follow up biplane contrast enhanced echocardiogram compared to the pre-discharge contrast enhanced echocardiogram
- Safety of contrast in this setting [ Time Frame: at the time of procedure to 6 month follow-up ]Assessed by any alterations on oxygen saturation or hemodynamic effects acutely related to ultrasound contrast administration
- Frequency of > 50% ST segment resolution by EKG at six hours post PCI. [ Time Frame: 6 hours post PCI ]
- Area under the CPK (Creatine Phosphokinase) versus time curve [ Time Frame: at time of procedure ]Quantifies infarct size
- Overall survival (OS) [ Time Frame: From date of randomization until the date of first documented progression or date of death from any cause, whichever comes first, assessed up to 120 months ]Defined as the time from the start of randomized treatment to death from any cause.
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): NCT02170103
|Contact: Thomas R Porter, MDfirstname.lastname@example.org|
|University of Sao Paulo Medical Center||Recruiting|
|Sao Paulo, Brazil|
|Contact: Wilson Mathias, Jr, MD (011) 98415-5556. email@example.com|
|VU University Medical Center||Not yet recruiting|
|Contact: Otto Kamp, MD|
|Principal Investigator:||Thomas R Porter, MD||University of NE Medical Center|