title: 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.
authors.affiliation: Department of Cardiology and Institute for Cardiovascular Research (ICaR-VU), VU University Medical Center, Amsterdam, The Netherlands; Interuniversity Cardiology Institute of the Netherlands (ICIN), Utrecht, The Netherlands. Electronic address: sebastiaanroos@gmail.com.
authors.forename: Sebastiaan T
authors.initials: ST
authors.lastname: Roos
authors.affiliation: Department of Cardiology and Institute for Cardiovascular Research (ICaR-VU), VU University Medical Center, Amsterdam, The Netherlands.
authors.forename: Lynda J M
authors.initials: LJ
authors.lastname: Juffermans
authors.affiliation: Department of Cardiology and Institute for Cardiovascular Research (ICaR-VU), VU University Medical Center, Amsterdam, The Netherlands.
authors.forename: Niels
authors.initials: N
authors.lastname: van Royen
authors.affiliation: Department of Cardiology and Institute for Cardiovascular Research (ICaR-VU), VU University Medical Center, Amsterdam, The Netherlands; Interuniversity Cardiology Institute of the Netherlands (ICIN), Utrecht, The Netherlands.
authors.forename: Albert C
authors.initials: AC
authors.lastname: van Rossum
authors.affiliation: University of Nebraska Medical Centre, Omaha, Nebraska, USA.
authors.forename: Feng
authors.initials: F
authors.lastname: Xie
authors.affiliation: Department of Cardiology and Institute for Cardiovascular Research (ICaR-VU), VU University Medical Center, Amsterdam, The Netherlands; Interuniversity Cardiology Institute of the Netherlands (ICIN), Utrecht, The Netherlands.
authors.forename: Yolande
authors.initials: Y
authors.lastname: Appelman
authors.affiliation: University of Nebraska Medical Centre, Omaha, Nebraska, USA.
authors.forename: Thomas R
authors.initials: TR
authors.lastname: Porter
authors.affiliation: Department of Cardiology and Institute for Cardiovascular Research (ICaR-VU), VU University Medical Center, Amsterdam, The Netherlands; Interuniversity Cardiology Institute of the Netherlands (ICIN), Utrecht, The Netherlands.
authors.forename: Otto
authors.initials: O
authors.lastname: Kamp
mesh_terms: D000328:Adult; D000818:Animals; D003331:Coronary Vessels / Q000503:physiopathology*; D004195:Disease Models, Animal; D005260:Female; D006801:Humans; D015994:Incidence; D008297:Male; D055806:Microvessels / Q000503:physiopathology*; D008875:Middle Aged; D009203:Myocardial Infarction / Q000628:therapy*; D013552:Swine; D016896:Treatment Outcome; D014464:Ultrasonic Therapy / Q000009:adverse effects* / Q000379:methods*; D014661:Vasoconstriction / Q000502:physiology*; D055815:Young Adult
keywords: Microvascular obstruction; Myocardial infarction; Sonothrombolysis; Theragnostic ultrasound; Ultrasound contrast agents