EUCTR2018-001277-24-NL
Active, not recruiting
Phase 1
Microvascular Recovery in Acute MI, a single center, prospective, randomized, single blind parallel-group comparison of sonothrombolysis versus standard of care performed after (post) coronary reperfusion (primary PCI). - MRUSMI
VU University Medical Center (VUmc)0 sites60 target enrollmentAugust 20, 2019
ConditionsST elevation myocardial infarctionTherapeutic area: Diseases [C] - Cardiovascular Diseases [C14]
DrugsLuminity
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- ST elevation myocardial infarction
- Sponsor
- VU University Medical Center (VUmc)
- Enrollment
- 60
- Status
- Active, not recruiting
- Last Updated
- 6 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility 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\)
- •\- Persistence of ST\-elevation of more than 30% after PCI in the lead with the highest ST\-elevation on the ECG after PCI compared to the ECG before PCI
- •\- Within 12 hours of symptom onset
- •\- Age \= 30 years
- •\- Adequate apical and/or parasternal images by echocardiography
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
Exclusion Criteria
- •\-Previous coronary bypass surgery
- •\-Cardiogenic shock
- •\-Known or suspected hypersensitivity to ultrasound contrast agent used for the study
- •\-Life expectancy of less than two months or terminally ill
- •\-Known bleeding diathesis or contraindication to glycoprotein IIB/IIIA inhibitors, anticoagulants or aspirin
- •\-Known large right to left intracardiac shunts
Outcomes
Primary Outcomes
Not specified
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