Safety and Efficacy of sonolysis therapy for treatment of microvascular damage after myocardial infarction

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. Therefore, there is a need for simpler and low-risk methods for effective recanalization of thrombosed arteries that can be initiated early in the disease process and after initial primary PCI treatment.

In this respect, 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.

We hypothesize that under influence of ultrasound, UCAs enhance dissolution of thrombus in patients with acute ST-elevation myocardial infarction premedicated with regular treatment with prasugrel, aspirin and heparin followed by bivalirudin and furthermore reduce the amount of microvascular obstruction that occurs after primary PCI.

Is application of diagnostic ultrasound and microbubbles prior and immediately after primary PCI to enhance coronary recanalization and reduce microvascular obstruction when combined with normal care consisting of prasugrel, aspirin and heparin followed by bivalirudin a safe and feasible method in this patient group?

First visit. 6 week follow-up. 6 month follow-up.

Patients will be announced by the ambulance. After announcement by the ambulance of a patient with an eligible STEMI the patient will be pre-treated in the ambulance with a loading dose of aspirin 500 mg iv., heparin 5000 IU iv., prasugrel 60mg po.
Upon arrival on the cathlab, after oral informed consent the patient will also receive Definity Microbubbles as part of the immediate ultrasound therapy



To avoid any time delay, informed consent will be obtained orally, prior to primary PCI and bivalirudin infusion. Investigator will try to obtain written informed consent prior to study procedures. In any other case, written informed consent will be given after primary PCI when the patient is in a stable clinical condition.

After informed consent, patients will be treated with ultrasound application with an UCA. To prevent delay of intended clinical treatment, the study procedure is carried out during the preparation for primary PCI as much as possible. The whole study procedure time including preparation is expected to take a maximum of 15 minutes. After PCI, the patient will receive an additional 30 minutes of UCA treatment.

An intravenous line will be inserted, and continuous registration of a 12-lead ECG is obtained. An automatic blood pressure device will record blood pressure every three minutes during the study procedure.