Microvascular Recovery in Acute MI, a multi center, prospective, randomized, single blind parallel-group comparison of sonothrombolysis versus standard of care performed after (post) coronary reperfusion (primary PCI).

Phase 3

Completed

Conditions: myocardial infarction and microcirculation
10011082

Registration Number: NL-OMON52724

Lead Sponsor: Vrije Universiteit Medisch Centrum

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 66

Inclusion Criteria

Patients presenting with STEMI within 12 hours of symptom onset and persisting
ST-elevation on the ECG after PCI >=30% in the lead with the highest elevation
compared to baseline ECG
Age >=30 years.
Adequate images with echocardiography

Exclusion Criteria

1. Previous coronary bypass surgery
2. Cardiogenic shock
3. Known or suspected hypersensitivity to ultrasound contrast agent used for
the study
4. Known bleeding diathesis or contraindication to glycoprotein 2b/3a
inhibitors, anticoagulants, or aspirin
6. Known large right to left intracardiac shunts

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Som of ST-segment elevation after 60 min post initiation of Study Protocol </p><br>

Secondary Outcome Measures

Name	Time	Method
<p>- Partial (>50%) and complete (>=70%) ST-segment resolution.<br /><br>- Size of the infarct as measured by late gadolinium enhancement (LGE) on<br /><br>cardiac magnetic resonance imaging (CMR) assessed on day 3-7 days and 4-6<br /><br>months after infarction (on patients who can have a CMR)<br /><br>- Left ventricular remodelling as assessed by contrast enhanced<br /><br>echocardiography.<br /><br>- The composite of all-cause death, cardiogenic shock, need for<br /><br>defibrillator placement, or congestive heart failure (CHF) through day 180</p><br>