Phase 2 Completed N=15 Treatment

Sonothrombolysis in Patients With STEMI

ST-Segment Elevation Myocardial Infarction

Source: ClinicalTrials.gov NCT03092089 ↗

Enrolled (actual)

Serious AEs

20.0%

Results posted

Jun 2021

Primary outcomePrimary: Number of Participants With Spontaneous Reperfusion — 2 participants

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.

Outcome Measures

Outcome	Result	p-value
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	—

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.

View full record on ClinicalTrials.gov →

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. Informational only — not medical advice.