Phase 2
N=15
Sonothrombolysis in Patients With STEMI
ST-segment Elevation Myocardial Infarction
Bottom Line
View on ClinicalTrials.gov: NCT03092089 ↗Enrolled (actual)
15
Serious AEs
20.0%
Results posted
Jun 2021
Primary outcome: Primary: Number of Participants With Spontaneous Reperfusion — 2 participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Definity, (Lipid Microspheres) Intravenous Suspension (Drug); Myocardial Contrast Echocardiography (Device); Repurfusion therapy with PPCI (Procedure)
- Age
- Adult, Older Adult · 30+ yrs
- Sex
- All
- Sponsor
- Harald Becher
- Primary completion
- Oct 2019
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Spontaneous Reperfusion |
7 | — |
| PRIMARY Number of Participants With Spontaneous Reperfusion |
7 | — |
| SECONDARY Number of Participants With Complete (>50%) ST-segment Resolution at 30 Minutes Post PCI |
14 | — |
| SECONDARY Left Ventricular Ejection Fraction (LVEF) by Echocardiography (ECHO) (Simpson Method) |
54.9; 54.6; 54.5; 52.3; 51.5 | — |
| SECONDARY Wall Motion Score Index (WMSI) by ECHO |
1.4; 1.5; 1.6; 1.8; 1.8 | — |
| SECONDARY Microvascular Perfusion Score Index (MPSI) by ECHO |
1.2; 1.3; 1.4; 1.6; 1.7 | — |
Summary
This study evaluates what effect sonothrombolysis may have on spontaneous reperfusion, microvascular obstruction, left ventricular function and infarct size in patients presenting with their first ST-segment Elevation Myocardial Infarction.
Eligibility Criteria
Inclusion Criteria
Patients presenting with STEMI within 6 hours of symptom onset and:
- Are expected to receive reperfusion therapy with primary PCI
- Have a high-risk STEMI ECG defined as:
- ≥2mm ST-segment elevation in 2 anterior or lateral leads; or
- ≥2 mm ST-segment elevation in 2 inferior leads coupled with ST segment depression in 2 contiguous anterior leads for a total ST-segment deviation of ≥4mm
- Age ≥30 years.
- Adequate apical and/or parasternal images by echocardiography
Exclusion Criteria
- Isolated inferior STEMI without anterior ST-segment depression
- 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 2b/3a inhibitors, anticoagulants, or aspirin
- Known large right to left intracardiac shunts.
Data sourced from ClinicalTrials.gov (NCT03092089). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.