Unexpected High Incidence of Coronary Vasoconstriction in the Reduction of Microvascular Injury Using Sonolysis (ROMIUS) Trial

Abstract High-mechanical-index ultrasound and intravenous microbubbles might prove beneficial in treating microvascular obstruction caused by microthrombi after primary percutaneous coronary intervention for ST-segment elevation myocardial infarction (STEMI). Experiments in animals have revealed that longer-pulse-duration ultrasound is associated with an improvement in microvascular recovery. This trial tested long-pulse-duration, high-mechanical-index ultrasound in STEMI patients. Non-randomly assigned, non-blinded patients were included in this phase 2 trial. The primary endpoint was any side effect possibly related to the ultrasound treatment. The study was aborted after six patients were included; three patients experienced coronary vasoconstriction of the culprit artery, unresponsive to nitroglycerin. Therefore, coronary artery diameter was measured in five pigs. Coronary artery diameters distal to the injury site decreased after application of ultrasound, after balloon injury plus thrombus injection (from 1.89 ± 0.24 mm before to 1.78 ± 0.17 after ultrasound, p = 0.05). Long-pulse-duration ultrasound might cause coronary vasoconstriction distal to the culprit vessel location.