Reduction Of Microvascular Injury Utilizing Sonolysis

Conditions: Myocardial infarction
Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]

Registration Number: EUCTR2014-002514-23-NL

Lead Sponsor: VU Medical Center

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Authorised-recruitment may be ongoing or finished

Sex: All

Target Recruitment: Not specified

Inclusion Criteria

•Age > 18 years
•acute onset (< 6 hours)
•diagnosed with STEMI according to the criteria of the ACC
•initial oral informed consent

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 20
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 20

Exclusion Criteria

•Clinical instability
•Known allergy to ultrasound contrast agents
•Any reason judged by the investigators to hamper inclusion

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: 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?;Secondary Objective: To investigate whether ultrasound in combination with UCAs has a beneficial effect on echocardiographic, Magnetic Resonance Imaging (MRI) and enzymatic infarct size in patients with acute myocardial infarction pretreated with prasugrel, aspirin and heparin.;Primary end point(s): •Echocardiographic and enzymatic infarct size<br>•Microvascular obstruction and haemorrhage on MRI measurements<br>;Timepoint(s) of evaluation of this end point: First week: continuous. After 6 months: outpatient clinic visit.

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): •Practicality / feasibility problems during imaging<br>•Other adverse events<br>•Other Serious adverse events<br>•Incidence of Major Adverse Cardiac Events (MACE)<br>;Timepoint(s) of evaluation of this end point: After 6 month follow-up.