MICROVASCULAR RECOVERY USING CONTRAST ULTRASOUND IN ST-ELEVATION MYOCARDIAL INFARCTION - AMBULANCE PILOT STUDY

Phase 2

Recruiting

Conditions: myocardial infarction and microcirculation
10011082

Registration Number: NL-OMON49044

Lead Sponsor: Vrije Universiteit Medisch Centrum

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Recruiting

Sex: Not specified

Target Recruitment: 10

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

- 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

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>- Safety, assessed by the occurrence of ventricular arrhythmias defined as<br /><br>sustained ventricular tachycardia and/or ventricular fibrillation and the<br /><br>occurrence of shock defined as a systolic blood pressure (SBP) <100mmHg in<br /><br>combination with tachycardia (HR > 100/min), after initiation of<br /><br>sonothrombolysis and before percutaneous coronary intervention.<br /><br>- Technical feasibility will be assessed by extent of sonothrombolysis<br /><br>completion during ambulance transfer and quality of the images.<br /><br>Sonothrombolysis completion will be measured by counting the number of applied<br /><br>high MI impulses and quality of the images will be assessed by counting the<br /><br>amount of visible segments during sonothrombolysis.</p><br>

Secondary Outcome Measures