SONOthrombolysis in Patients With an ST-segment Elevation Myocardial Infarction With fibrinoLYSIS (SONOSTEMI-LYSIS) Trial (SONOSTEMILYSIS)

This study will assess the safety and feasibility of sonothrombolysis in the acute management of STEMI undergoing reperfusion therapy with systemic fibrinolysis as part of a pharmacoinvasive approach

Study Overview

• Status: Terminated
• Conditions: ST Elevation Myocardial Infarction
• Intervention / Treatment: Drug: Definity® with High Mechanical Index Ultrasound

Detailed Description

This study is an open label, single-centre, randomized investigation of sonothrombolysis in 60 adult patients presenting with STEMI within 6 hours of the onset of clinical symptoms and receiving perfusion therapy with fibrinolysis as part of a pharmacoinvasive strategy.

Patients will be randomized 2:1 to either adjunct treatment with sonothrombolysis or standard therapy alone according to the current American College of Cardiology/American Heart Association (ACC/AHA) or European Society of Cardiology (ESC) STEMI and PCI guidelines. All patients will receive serial echocardiography assessments during and after reperfusion with the final ECHO assessment at 90 days (+/- 7d) post reperfusion. Patient outcomes (medical records review) will be followed for 1 year after reperfusion.

• Study Type: Interventional
• Enrollment (Actual): 41
• Phase: Phase 2

Contacts and Locations

Study Locations

• Canada
  • Alberta
    • Edmonton, Alberta, Canada
      • University of Alberta

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Patients presenting with STEMI within 6 hours of symptom onset and:

  1. Are expected to receive reperfusion therapy with fibrinolysis

  2. Have a high-risk STEMI ECG as defined as:

     • >2mm ST-segment elevation in 2 anterior or lateral leads; or
     • >2mm 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
  3. Age >30 years
  4. Adequate apical and/or parasternal images by echocardiography

Exclusion Criteria:

• 1. Isolated inferior STEMI without anterior ST-segment depression 2. Previous coronary bypass surgery 3. Cardiogenic shock 4. Known or suspected hypersensitivity to ultrasound contrast agent used for the study 5. Life expectancy of less than two months or terminally ill 6. Known bleeding diathesis or contraindication to glycoprotein 2b/3a inhibitors, anticoagulants, or aspirin 7. Known large right to left intracardiac shunts 8. Patient received another investigational medication or treatment within 30 days prior to presentation with STEMI

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Sonothrombolysis; Diagnostic myocardial contrast echocardiography with ultrasound contrast agent 5% Definity® plus Sonothrombolysis	Drug: Definity® with High Mechanical Index Ultrasound; Sonothrombolysis; Echocardiographic imaging with intermittent diagnostic high mechanical index during an intravenous 5% Definity® infusion
No Intervention: Standard of Care; Diagnostic myocardial contrast echocardiography with ultrasound contrast agent 5% Definity®

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Complete ST-Segment Resolution	ST-segment recovery as assessed by complete ST-segment resolution (>50%)	90 minutes post TNK administration

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Frequency of rescue/urgent PCI	Frequency of rescue/urgent PCI following the administration of fibrinolysis.	approximately 3-24 hours post TNK administration
ST-segment resolution (>50%)	ST-segment resolution (>50%) following a pharmacoinvasive approach at ~30 minutes post PCI as assessed by the worst lead on electrocardiogram	approximately 30 minutes post TNK administration
ST-segment resolution (continuous)	ST-segment resolution (continuous) following a pharmacoinvasive approach at ~30 minutes post PCI as assessed by the worst lead on electrocardiogram	approximately 30 minutes post TNK administration
Left ventricular ejection fraction	Left ventricular ejection fraction by ECHO (Simpson method) assessed on Day 1 (pre reperfusion), Day 3 +/-2d (hospital discharge), and Day 90 +/-2d after infarction.	Day 1 (pre reperfusion), Day 3 +/-2d (hospital discharge), and Day 90 +/-2d after infarction.
Wall motion score index (WMSI)	Wall motion score index (WMSI) by ECHO assessed on Day 1 (pre reperfusion), Day 3 +/-2d (hospital discharge), and Day 90 +/-2d after infarction. Each of the 17 LV segments is classified as: 1 normal 2.hypokinetic 3.akinetic 4.dyskinetic The WMS index is the sum of the scores divided by the number of segments. Usually 17, but if a segment cannot be classified, the sum is divided by the number of readable segments. Minimum value is 1 : all segments are normal - best outcome Maximum value is 4: all segments are dyskinetic - worst outcome	Day 1 (pre reperfusion), Day 3 +/-2d (hospital discharge), and Day 90 +/-2d after infarction.
Microvascular perfusion score index (MPSI)	Microvascular perfusion score index (MPSI) by ECHO assessed on Day 1 (pre reperfusion), Day 3 +/-2d (hospital discharge), and Day 90 +/-2d after infarction Each of the 17 LV segments is classified as: normal, contrast replenishment within 4 seconds; mildly reduced, contrast replenishment takes longer than 4 seconds; no contrast replenishment over 10 seconds The MPSI index is the sum of the scores divided by the number of segments. Usually 17, but if a segment cannot be classified, then the sum is divided by the number of readable segments Minimum value is 1 : all segments are normal - best outcome Maximum value is 3: all segments are not perfused - worst outcome	Day 1 (pre reperfusion), Day 3 +/-2d (hospital discharge), and Day 90 +/-2d after infarction.
Global Longitudinal Strain (GLS)	Global Longitudinal Strain (GLS) by ECHO assessed on Day 1 (pre reperfusion), Day 3 +/-2d (hospital discharge), and Day 90 +/-2d after infarction GLS is measured using speckle tracking imaging (Epiq, Philips). The scale is - % which means percentage of longitudinal shortening of myocardial segments. Similar to the WMSI, GLS is calculated by dividing the sum of the longitudinal strain measurements in the myocardial segments segments by the number of segments which can be assessed by speckle tracking (18 when all segments in all 3 apical views can be analysed. The lower the absolute strain value the worse the LV function.	Day 1 (pre reperfusion), Day 3 +/-2d (hospital discharge), and Day 90 +/-2d after infarction.
QRS Score	Selvester QRS Scoring System, assessed on Day 3 +/-2d (hospital discharge) ECG. Minimum score 0, Maximum score 32. Higher score indicates worse outcome.	Day 3 +/-2d (hospital discharge)

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Composite of death/shock, heart failure/new myocardial infarction in hospital	Composite of death/shock, heart failure/new myocardial infarction in hospital	Until hospital discharge, approximately 5 days
Composite of death/shock, heart failure/new myocardial infarction at 1-year	Composite of death/shock, heart failure/new myocardial infarction at 1-year	1 year
TIMI flow grade pre and post PCI on index angiogram	TIMI flow grade pre and post PCI on index angiogram	pre and post PCI on index angiogram, approximately 3-24 hours post TNK administration

Collaborators and Investigators

• Sponsor: University of Alberta
• Collaborators: Canadian VIGOUR Centre

Study record dates

Study Major Dates

• Study Start (Actual): February 23, 2021
• Primary Completion (Actual): January 19, 2026
• Study Completion (Actual): January 19, 2026

Study Registration Dates

• First Submitted: January 2, 2020
• First Submitted That Met QC Criteria: January 2, 2020
• First Posted (Actual): January 3, 2020

Study Record Updates

• Last Update Posted (Actual): March 4, 2026
• Last Update Submitted That Met QC Criteria: March 2, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Vascular Diseases; Cardiovascular Diseases; Pathologic Processes; Heart Diseases; Infarction; Necrosis; Myocardial Ischemia; Myocardial Infarction; Ischemia; Pathological Conditions, Signs and Symptoms; ST Elevation Myocardial Infarction; perflutren
• Other Study ID Numbers: Pro00093814

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: Yes