Microvascular Recovery in Acute MI, a multi center, prospective, randomized, single blind parallel-group comparison of sonothrombolysis versus standard of care performed after (post) coronary reperfusion (primary PCI).

Rationale: The optimal treatment strategy in patients with acute ST-elevated
myocardial infarction (STEMI) is immediate restoration of epicardial coronary
blood flow. Thrombolytic therapy is the most widely used therapy, however,
important limitations are a relatively low recanalization rate, and hemorrhagic
complications. Currently, primary percutaneous coronary intervention (PCI) is
the treatment of choice in STEMI patients, however, its widespread use is
hampered by limited availability of specialized facilities and trained staff.
Also, peripheral microvascular obstruction often occurs, as part of the
microvascular injury pathway. Additional drugs can be administered in this
case, but detection of this obstruction is difficult, even with intracoronary
measurements using specialized wires. A method by which this microvascular
obstruction might be visualized is with ultrasound echocardiography and
ultrasound contrast agents (UCAs). Luminity ®, an UCA, is recently
re-introduced in Europe and is used to diagnostically image the myocardium even
during PCI to visualize myocardial perfusion and indirectly obtain information
on the amount of microvascular obstruction. This can enhance additional therapy
given immediately after PCI and might reduce over-medication in patients. We
hypothesize that UCA administration with Luminity ® with continuous ultrasound
directly after PCI can be safely used to visualize the myocardial perfusion in
the setting of acute ST-elevation myocardial infarction in patients
premedicated with prasugrel or ticagrelor, aspirin and heparin.
Additionally, the application of ultrasound, and ultrasound in combination with
thrombolytic agents have been investigated and were found to enhance thrombus
dissolution in vitro and in vivo. Pilot studies demonstrated that ultrasound
and microbubbles might have a beneficial effect on the microcirculation in
humans.

To compare the relative efficacy of sonothrombolysis in the acute management of
STEMI following primary percutaneous coronary intervention [PCI] in patients
with persistent ST elevation compared with standard of care.

The Microvascular Recovery in Acute MI will be a multi center, prospective,
randomized, single blind parallel-group comparison of sonothrombolysis versus
standard of care performed after (post) coronary reperfusion (primary PCI).

MRUSMI
Sonothrombolysis: Intermittent diagnostic high mechanical index (MI) at 1.1 MI
using an iE33 to the myocardium during an intravenous Luminity®, post PCI for
30 minutes
Control : Standard of care

Use of ultrasound contrast agent with very small risk of allergic reaction.
The study will be performed in a safe environment on the coronary care unit
(and in the case of Ambulance sub study in the ambulance). Instable patients
(cardiogenic shock etc.) will be excluded