myocardial infarction and microcirculation
Conditions
Interventions
Sonothrombolysis: contrast enhanced echocardiography with intermittent high MI
impulses (see above)
Sponsors
Vrije Universiteit Medisch Centrum
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: Patients presenting with STEMI with:, - >= 2mm ST-segment elevation in 2 anterior or lateral leads; or - >= 1 mm ST-segment elevation in 2 inferior leads - >= 1mm ST-segment elevation in lateral leads (I, aVL, V5, V6) AND - Within 12 hours of symptom onset - Age >= 30 years - Adequate apical and/or parasternal images by echocardiography
Exclusion criteria
Exclusion criteria: - Previous coronary bypass surgery - Cardiogenic shock - Known or suspected hypersensitivity to ultrasound contrast agent used for the study - Known bleeding diathesis or contraindication to glycoprotein IIB/IIIA inhibitors, anticoagulants or aspirin - Known large right to left intracardiac shunts
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| - Safety, assessed by the occurrence of ventricular arrhythmias defined as sustained ventricular tachycardia and/or ventricular fibrillation and the occurrence of shock defined as a systolic blood pressure (SBP) 100/min), after initiation of sonothrombolysis and before percutaneous coronary intervention. - Technical feasibility will be assessed by extent of sonothrombolysis completion during ambulance transfer and quality of the images. Sonothrombolysis completion will be measured by counting the number of applied high MI impulses and quality of the images will be assessed by counting the amount of visible segments during sonothrombolysis. | — |
Secondary
| Measure | Time frame |
|---|---|
| - Cumulative ST-elevation resolution - Angiographic patency rate on coronary angiography - Myocardial infarct size by delayed enhancement imaging, as well as the salvageability index, defined as the difference between extent of delayed enhancement by Gd MRI and the T2 weighted double or triple inversion spin echo assessment of risk area, divided by the area at risk. Presence and extent of myocardial injury. Scar size, LVEF and other quantitative assessments as function of LV mass/volume. - Frequency of left ventricular remodeling - Myocardial perfusion on follow up contrast enhanced echocardiography - Maximum CPK and troponin - Occurrence of adverse events (AEs), serious adverse events (SAEs), suspected unexpected serious adverse reactions (SUSARs) and six month event free survival. AE is defined as any untoward medical occurrence in the patient during the intervention period (one hour after sonothrombolysis initiation), whether or not considered causally related to the intervention. SAE is defined as any untoward medical occurrence that at any dose results in a life-threatening situation or death, or requires (prolongation of) hospitalization or results in a persistent or significant disability during 6 month follow up. SUSARs are defined as the occurrence of hypotension, ventricular rhythm disorders, cardiac arrest and/or anaphylaxis within one hour after sonothrombolysis initiation. Six-month event free survival is calculated from treatment initiation to six months afterwards, where events include death, congestive heart failure, life threatening arrhythmias, recurrence of ACS and need for prophylactic defibrillator. | — |
Countries
Netherlands
Outcome results
None listed