Using ultrasound to enhance treatment for heart attack patients
SONOthrombolysis in Patients With an ST-segment Elevation Myocardial Infarction With fibrinoLYSIS (SONOSTEMI-LYSIS) Trial
This study is testing if using ultrasound along with standard treatment can help heart attack patients recover better after their symptoms start.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 60 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University of Alberta Academic / other |
| Locations | 1 site (Edmonton, Alberta) |
| Trial ID | NCT04217304 on ClinicalTrials.gov |
What this trial studies
This trial investigates the safety and feasibility of sonothrombolysis as an adjunct treatment for patients experiencing ST-segment elevation myocardial infarction (STEMI) who are receiving fibrinolysis. It is a randomized, open-label study involving 60 adult patients who present within 6 hours of symptom onset. Participants will be assigned to receive either standard therapy or sonothrombolysis in addition to their current treatment. The study will monitor patient outcomes through echocardiography assessments during and after treatment, with follow-up for one year post-reperfusion.
Who should consider this trial
Good fit: Ideal candidates are adults over 30 presenting with high-risk STEMI within 6 hours of symptom onset who are expected to receive fibrinolysis.
Not a fit: Patients with isolated inferior STEMI, previous coronary bypass surgery, or those with contraindications to the study treatments may not benefit.
Why it matters
Potential benefit: If successful, this approach could improve the effectiveness of treatment for heart attack patients, potentially leading to better recovery outcomes.
How similar studies have performed: While the use of sonothrombolysis is a novel approach, similar studies have shown promise in enhancing thrombolytic therapy outcomes.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Edmonton, Alberta
- University of Alberta — Edmonton, Alberta, Canada (Recruiting)
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.