Ultrasound-Assisted Thrombolysis for Heart Attack

(SONOSTEMILYSIS Trial)

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: University of Alberta

Must be taking: Fibrinolytics

Must not be taking: Anticoagulants, Aspirin

Disqualifiers: Coronary bypass, Cardiogenic shock, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Approved in 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 2

Duration: 1 day

60 Participants Needed

Trial Summary

What is the purpose of this trial?

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

Will I have to stop taking my current medications?

The trial protocol does not specify whether you need to stop taking your current medications. However, if you are taking medications that are contraindicated with the study's treatments, such as certain anticoagulants or aspirin, you may need to adjust your medication regimen.

What data supports the effectiveness of the treatment Definity® for heart attacks?

The research primarily discusses the use of Definity® as an ultrasound contrast agent to improve heart imaging, which helps in better diagnosing heart conditions. While it doesn't directly address heart attack treatment, its ability to enhance cardiac imaging could indirectly support better management of heart-related issues. ^{1 2 3 4 5}

How does ultrasound-assisted thrombolysis differ from other heart attack treatments?

Ultrasound-assisted thrombolysis for heart attacks is unique because it combines ultrasound waves with a contrast agent, like Definity, to enhance the breakdown of blood clots. This method can accelerate clot dissolution and improve blood flow more quickly compared to traditional clot-busting drugs alone. ^{1 2 3 4 6}

Eligibility Criteria

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.

Inclusion Criteria

You need to have clear images of your heart from certain angles on an echocardiogram.

My ECG shows significant changes indicating a severe heart attack.

I am older than 30 years.

Exclusion 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 have a specific type of heart attack with no signs of another type of heart problem.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Treatment

Participants receive sonothrombolysis or standard therapy for STEMI within 6 hours of symptom onset

1 day

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment, including serial echocardiography assessments

90 days

Multiple visits (in-person) at Day 1, Day 3, and Day 90

Long-term follow-up

Patient outcomes are followed for 1 year after reperfusion

1 year

Treatment Details

Interventions

• Definity®

Trial Overview 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.

Participant Groups

Group I: Sonothrombolysis Experimental Treatment 1 Intervention

Diagnostic myocardial contrast echocardiography with ultrasound contrast agent 5% Definity® plus Sonothrombolysis

Group II: Standard of Care Active Control 1 Intervention

Diagnostic myocardial contrast echocardiography with ultrasound contrast agent 5% Definity®

Who Is Running the Clinical Trial?

University of Alberta

Lead Sponsor

Trials

957

Recruited

437,000+

Canadian VIGOUR Centre

Collaborator

Trials

9

Recruited

11,000+

Findings from Research

In a study involving 1,060 patients, Definity (perflutren lipid microsphere) was found to be well tolerated, with no deaths or serious adverse events reported during or within 30 minutes after administration.

The overall adverse event rate was 10.8%, with a low drug-related adverse event rate of 3.5%, indicating that most adverse events were mild or moderate, making Definity a safe option for patients with suboptimal echocardiograms.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

CaRES (Contrast Echocardiography Registry for Safety Surveillance): a prospective multicenter study to evaluate the safety of the ultrasound contrast agent definity in clinical practice. Weiss, RJ., Ahmad, M., Villanueva, F., et al.[2022]

In two patients with cardiac tamponade, echocardiographic-guided pericardiocentesis successfully drained bloody fluid, demonstrating the procedure's efficacy in managing this condition.

The use of Definity perflutren lipid microspheres as echocardiographic contrast during the procedure is a novel approach that enhanced the accuracy of needle placement, marking the first reported application of this technique.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Perflutren microspheres for contrast echocardiography in a bloody pericardiocentesis. Escabí-Mendoza, JE., Martínez-Díaz, JD., Avilés-Rivera, ED.[2018]

In the first year of using the second-generation contrast agent Definity in echocardiography, 161 patients showed a significant improvement in endocardial definition scores (p=0.0001), enhancing the clarity of heart imaging.

The use of contrast echocardiography led to the detection of clinically significant conditions that were missed in standard 2D imaging, with a very low adverse event rate of only 0.6%, indicating its safety and efficacy in clinical practice.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Contrast echocardiography in Australian clinical practice. Hamilton-Craig, C., Boga, T., West, C., et al.[2022]

Echocardiography, while commonly used to assess heart function, can be suboptimal in 15-20% of cases, but using ultrasound microbubble contrast like DEFINITY® significantly improves diagnostic accuracy and helps salvage nondiagnostic studies.

DEFINITY® is an FDA-approved microbubble contrast agent that enhances left ventricular imaging, providing clearer assessments of cardiac function and wall motion abnormalities, with a well-defined safety profile and clinical indications.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Review of ultrasound contrast agents in current clinical practice with special focus on DEFINITY® in cardiac imaging. Salih, M., Ali, SM., Jena, N., et al.[2022]

A 73-year-old patient experienced sudden death shortly after receiving a perflutren contrast agent during an echocardiogram, highlighting potential risks associated with its use in patients with severe heart conditions.

Despite the timing of the death, autopsy results did not establish a direct link between the perflutren agent and the fatal event, suggesting that this case may represent a pseudocomplication rather than a direct adverse effect.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Sudden death after intravenous administration of a perflutren contrast agent: a case of pseudocomplication? Mahjoub, H., Roméo, P., Leung, TK., et al.[2014]

Using a clinical ultrasound contrast agent (Definity) combined with 220 kHz pulsed ultrasound significantly enhances the effectiveness of rt-PA in dissolving blood clots, as shown in both laboratory and preclinical studies.

In a porcine model of cerebral thromboembolism, this combination treatment accelerated reperfusion by up to 45 minutes compared to rt-PA or saline alone, indicating a promising approach for improving thrombolysis outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Accelerated sonothrombolysis with Definity in a xenographic porcine cerebral thromboembolism model. Kleven, RT., Karani, KB., Hilvert, N., et al.[2023]

References

1. United States pubmed.ncbi.nlm.nih.gov

CaRES (Contrast Echocardiography Registry for Safety Surveillance): a prospective multicenter study to evaluate the safety of the ultrasound contrast agent definity in clinical practice. [2022]

2. United States pubmed.ncbi.nlm.nih.gov

Perflutren microspheres for contrast echocardiography in a bloody pericardiocentesis. [2018]

3. Australia pubmed.ncbi.nlm.nih.gov

Contrast echocardiography in Australian clinical practice. [2022]

4. England pubmed.ncbi.nlm.nih.gov

Review of ultrasound contrast agents in current clinical practice with special focus on DEFINITY® in cardiac imaging. [2022]

5. United States pubmed.ncbi.nlm.nih.gov

Sudden death after intravenous administration of a perflutren contrast agent: a case of pseudocomplication? [2014]

6. England pubmed.ncbi.nlm.nih.gov

Accelerated sonothrombolysis with Definity in a xenographic porcine cerebral thromboembolism model. [2023]