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Ultrasound-Assisted Thrombolysis for Heart Attack (SONOSTEMILYSIS Trial)

Phase 2
Recruiting
Research Sponsored by University of Alberta
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Patients with a high-risk STEMI ECG as defined by >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
Age >30 years
Must not have
Previous coronary bypass surgery
Known bleeding diathesis or contraindication to glycoprotein 2b/3a inhibitors, anticoagulants, or aspirin
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 1 year
Awards & highlights
No Placebo-Only Group

Summary

This trial will test whether using sound waves in addition to standard medical care can help improve outcomes for people having a heart attack.

Who is the study for?
This trial is for heart attack patients over 30 years old who are receiving clot-dissolving therapy within 6 hours of symptom onset. It's specifically for those with high-risk ECG patterns indicating severe heart attacks. People can't join if they're allergic to ultrasound contrast agents, have a bleeding disorder, major heart shunts, took experimental treatments recently, had prior bypass surgery or are in cardiogenic shock.
What is being tested?
The SONOSTEMI-LYSIS Trial is testing the combination of Definity® (an ultrasound contrast agent) with High Mechanical Index Ultrasound to see if it's safe and works well when used alongside standard clot-dissolving drugs in treating severe heart attacks.
What are the potential side effects?
Potential side effects may include reactions to the ultrasound contrast agent like headaches, nausea or more serious allergic reactions. The procedure might also cause discomfort or bruising where the ultrasound is applied.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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My ECG shows significant changes indicating a severe heart attack.
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I am older than 30 years.
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I had a severe heart attack and got treatment within 6 hours.
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I am expected to undergo a clot-dissolving treatment.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
Select...
I have had coronary bypass surgery in the past.
Select...
I cannot take certain blood thinners or aspirin due to a bleeding disorder.
Select...
I have had a severe heart condition called cardiogenic shock.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~1 year
This trial's timeline: 3 weeks for screening, Varies for treatment, and 1 year for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Complete ST-Segment Resolution
Secondary study objectives
Frequency of rescue/urgent PCI
Global Longitudinal Strain (GLS)
Left ventricular ejection fraction
+5 more
Other study objectives
Composite of death/shock, heart failure/new myocardial infarction at 1-year
Composite of death/shock, heart failure/new myocardial infarction in hospital
TIMI flow grade pre and post PCI on index angiogram

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: SonothrombolysisExperimental Treatment1 Intervention
Diagnostic myocardial contrast echocardiography with ultrasound contrast agent 5% Definity® plus Sonothrombolysis
Group II: Standard of CareActive Control1 Intervention
Diagnostic myocardial contrast echocardiography with ultrasound contrast agent 5% Definity®

Find a Location

Who is running the clinical trial?

University of AlbertaLead Sponsor
940 Previous Clinical Trials
433,971 Total Patients Enrolled
11 Trials studying Myocardial Infarction
1,893 Patients Enrolled for Myocardial Infarction
Canadian VIGOUR CentreOTHER
8 Previous Clinical Trials
10,938 Total Patients Enrolled
3 Trials studying Myocardial Infarction
1,052 Patients Enrolled for Myocardial Infarction

Media Library

Definity® with High Mechanical Index Ultrasound Clinical Trial Eligibility Overview. Trial Name: NCT04217304 — Phase 2
Myocardial Infarction Research Study Groups: Sonothrombolysis, Standard of Care
Myocardial Infarction Clinical Trial 2023: Definity® with High Mechanical Index Ultrasound Highlights & Side Effects. Trial Name: NCT04217304 — Phase 2
Definity® with High Mechanical Index Ultrasound 2023 Treatment Timeline for Medical Study. Trial Name: NCT04217304 — Phase 2
~6 spots leftby May 2025
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