Microvascular Reperfusion Utilizing Sonothrombolysis in Acute Myocardial Infarction (MRUSMI TRIAL)
Status:
Unknown status
Trial end date:
1969-12-31
Target enrollment:
Participant gender:
Summary
The investigators propose to test the effectiveness of a technique that uses a modified
commercially available ultrasound system used for cardiac imaging, and a commercially
available ultrasound contrast agent (microbubbles) to break up the blood clots that cause
heart attacks. The ultrasound and microbubbles will be applied as soon as possible to
patients presenting to the emergency department, after an EKG confirms that a heart attack is
ongoing. 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. Following the randomized
treatment, patients will be followed for the development of any complications (recurrent
heart attack, heart failure, or need for defibrillator placement) as well as by echo and
cardiac MRI to determine how much heart muscle was salvaged by the treatment. A total of 250
patients will be enrolled and followed at two different sites. Randomization will be
stratified at each study site. The initial site enrolling patients will be University of Sao
Paulo Medical School. Wilson Mathias, MD, will serve as the principal investigator for this
site. The other is VU University Medical Center in Amsterdam, where Otto Kamp, MD, will serve
as the principal investigator.