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

Recruiting

Conditions: Myocardial infarctionHartinfarct

Registration Number: NL-OMON28497

Lead Sponsor: VU University Medical Center

Brief Summary: 1 Daffertshofer M, Gass A, Ringleb P, et al. Transcranial low-frequency ultrasound-mediated thrombolysis in brain ischemia: increased risk of hemorrhage with combined ultrasound and tissue plasminogen activator: results of a phase II clinical trial. Stroke 2005 Jul;36(7):1441-6. 2 Scott PA, Frederiksen SM, Kalbfleisch JD, et al. Safety of intravenous thrombolytic use in four emergency departments without acute stroke teams. Acad Emerg Med 2010 Oct;17(10):1062-71. 3 Kramer C, Aguilar MI, Hoffman-Snyder C, et al. Safety and efficacy of ultrasound-enhanced thrombolysis in the treatment of acute middle cerebral artery infarction: a critically appraised topic. Neurologist 2011 Nov;17(6):346-51. 4 Xie F, Lof J, Matsunaga T, et al. Diagnostic ultrasound combined with glycoprotein IIb/IIIa-targeted microbubbles improves microvascular recovery after acute coronary thrombotic occlusions. Circulation 2009 Mar 17;119(10):1378-85. 5 Gibson CM, Cannon CP, Daley WL, et al. TIMI frame count: a quantitative method of assessing coronary artery flow. Circulation 1996 Mar 1;93(5):879-88. 6 Ndrepepa G, Tiroch K, Keta D, et al. Predictive factors and impact of no reflow after primary percutaneous coronary intervention in patients with acute myocardial infarction. Circ Cardiovasc Interv 2010 Feb 1;3(1):27-33. 7 Kloner RA, Ganote CE, Jennings RB. The "no-reflow" phenomenon after temporary coronary occlusion in the dog. J Clin Invest 1974 Dec;54(6):1496-508. 8 Kondo M, Nakano A, Saito D, et al. Assessment of "microvascular no-reflow phenomenon" using technetium-99m macroaggregated albumin scintigraphy in patients with acute myocardial infarction. J Am Coll Cardiol 1998 Oct;32(4):898-903. 9 Cavalcante JL, Collier P, Plana JC, et al. Two-dimensional longitudinal strain assessment in the presence of myocardial contrast agents is only feasible with speckle-tracking after microbubble destruction. J Am Soc Echocardiogr 2012 Dec;25(12):1309-18. 10 Slikkerveer J, Kleijn SA, Appelman Y, et al. Ultrasound Enhanced Prehospital Thrombolysis Using Microbubbles Infusion in Patients with Acute ST Elevation Myocardial Infarction: Pilot of the Sonolysis Study. Ultrasound Med Biol 2011 Dec 16.

Detailed Description: Not available

Recruitment & Eligibility

Status: Recruiting

Sex: Not specified

Target Recruitment: 20

Inclusion Criteria

•Age > 18 years

•Acute onset (< 6 hours)

Exclusion Criteria

•Clinical instability

•Known allergy to ultrasound contrast agents

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
•Echocardiographic and enzymatic infarct size<br /><br>•Microvascular obstruction and haemorrhage on MRI measurements

Secondary Outcome Measures

Name	Time	Method
•Practicality / feasibility problems during imaging<br /><br>•Other adverse events<br /><br>•Other Serious adverse events<br /><br>•Incidence of Major Adverse Cardiac Events (MACE)