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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 1 year
Awards & highlights
SONOSTEMILYSIS Trial 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.Check my eligibility
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.See study design
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.
SONOSTEMILYSIS Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My ECG shows significant changes indicating a severe heart attack.
Select...
I am older than 30 years.
Select...
I had a severe heart attack and got treatment within 6 hours.
Select...
I am expected to undergo a clot-dissolving treatment.
SONOSTEMILYSIS Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 1 year
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~1 year
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Complete ST-Segment Resolution
Secondary outcome measures
Frequency of rescue/urgent PCI
Global Longitudinal Strain (GLS)
Left ventricular ejection fraction
+5 moreOther outcome measures
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
SONOSTEMILYSIS 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
889 Previous Clinical Trials
385,074 Total Patients Enrolled
8 Trials studying Myocardial Infarction
997 Patients Enrolled for Myocardial Infarction
Canadian VIGOUR CentreOTHER
8 Previous Clinical Trials
10,988 Total Patients Enrolled
1 Trials studying Myocardial Infarction
200 Patients Enrolled for Myocardial Infarction
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Eligibility Criteria:
This trial includes the following eligibility criteria:- You have taken another experimental medication or treatment within the last 30 days before having a heart attack.I have had coronary bypass surgery in the past.You need to have clear images of your heart from certain angles on an echocardiogram.You have a specific type of heart attack with no signs of another type of heart problem.You have had a bad reaction to the special liquid used for the ultrasound test in the past.My ECG shows significant changes indicating a severe heart attack.I am older than 30 years.I had a severe heart attack and got treatment within 6 hours.You have a very short life expectancy or are seriously ill.I cannot take certain blood thinners or aspirin due to a bleeding disorder.I have had a severe heart condition called cardiogenic shock.You have a large hole between the right and left sides of your heart.I am expected to undergo a clot-dissolving treatment.
Research Study Groups:
This trial has the following groups:- Group 1: Sonothrombolysis
- Group 2: Standard of Care
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Is there evidence to suggest Definity® is effective when paired with High Mechanical Index Ultrasound?
"Currently, there are 19 clinical studies underway for Definity® with High Mechanical Index Ultrasound-- 1 of which is in its third phase. Philadelphia, Pennsylvania serves as the primary trial site; however, 26 other cities host trials for this treatment."
Answered by AI
What is the aggregate figure of participants involved in this investigation?
"Affirmative. The information hosted on clinicaltrials.gov shows this scientific trial is currently seeking participants, with 60 patients required across a single site. It was published on February 23rd 2021 and most recently revised May 16th 2022."
Answered by AI
Does the FDA recognize Definity® with High Mechanical Index Ultrasound as a legitimate medical treatment?
"The safety of Definity® with High Mechanical Index Ultrasound was rated a 2, as it is only in the second phase of clinical trials and data has yet to be collected proving efficacy."
Answered by AI
What medical applications is Definity® with High Mechanical Index Ultrasound usually utilized for?
"Definity® with High Mechanical Index Ultrasound is a viable option for diagnosing cardiovascular diseases and obtaining diagnostic imaging using echocardiography."
Answered by AI
Are there any remaining slots available to participants in this experiment?
"Indeed, the information hosted on clinicaltrials.gov reveals that enrollment is still open for this medical trial. First posted in February 2021 and recently updated in May of 2022, this research aims to recruit 60 patients from a single clinic site."
Answered by AI
Who else is applying?
What state do they live in?
California
How old are they?
18 - 65
What site did they apply to?
University of Alberta
What portion of applicants met pre-screening criteria?
Met criteria
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