Using ultrasound to improve blood flow in heart attack patients
High Ultrasound Mechanical Index and MicrobuBBLEs to Reduce Acute Myocardial Infarction Burden I
University of Sao Paulo General Hospital · NCT04732091
This study is testing if a new ultrasound treatment can help improve blood flow and recovery in heart attack patients compared to a placebo.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 540 (estimated) |
| Ages | 30 Years and up |
| Sex | All |
| Sponsor | University of Sao Paulo General Hospital (other) |
| Locations | 2 sites (Omaha, Nebraska and 1 other locations) |
| Trial ID | NCT04732091 on ClinicalTrials.gov |
What this trial studies
This study investigates the effectiveness of sonothrombolysis, a technique that combines diagnostic ultrasound with intravenous microbubble infusion, in treating acute coronary artery disease. It aims to demonstrate how high mechanical index impulses can enhance blood flow and improve outcomes in patients with acute myocardial infarction and unstable angina. The study will involve 540 participants who will be randomized to receive either the ultrasound treatment or a placebo, with comparisons made on various clinical outcomes. Additionally, the research seeks to develop a portable ultrasound device for easier application in emergency settings.
Who should consider this trial
Good fit: Ideal candidates include adults aged 30 and older with acute myocardial infarction or high-risk unstable angina who are eligible for emergency PCI.
Not a fit: Patients with contraindications to ultrasound contrast agents, severe cardiogenic shock, or those with a life expectancy of less than two months may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly improve recovery and outcomes for patients experiencing heart attacks.
How similar studies have performed: Previous studies have shown promising results with sonothrombolysis, indicating potential for success in this novel application.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Age ≥30 years with STEMI with less than 12 hours of chest pain onset. * Age ≥30 years with STEMI initially treated in a primary setting by fibrinolytic therapy within 12h * Age ≥30 years with NSTEMI with high-risk unstable angina who will undergo elective PCI * Eligible for emergent PCI therapy. * No contraindications or hypersensitivities to ultrasound contrast agents Exclusion Criteria: * Known or suspected hypersensitivity to ultrasound contrast agent used for the study. * Cardiogenic Shock. * Life expectancy of less than two months or terminally ill. * Known bleeding diathesis or contraindication to glycoprotein 2b/3a inhibitors, anticoagulants, or aspirin. * Known large right to left intracardiac shunts or severe pulmonary hypertension. * Patients who received thrombolytic therapy previously to enrollment. * Women of childbearing potential.
Where this trial is running
Omaha, Nebraska and 1 other locations
- Department of Internal Medicine, Division of Cardiovascular Medicine, University of Nebraska Medical Center — Omaha, Nebraska, United States (ACTIVE_NOT_RECRUITING)
- Heart Institute of Clinical Hospital of Medical School of University of Sao Paulo — Sao Paulo, Brazil (RECRUITING)
Study contacts
- Principal investigator: Wilson Mathias Jr, MD, PhD — Heart Institute - University of São Paulo Medical School
- Study coordinator: Wilson Mathias Jr, MD, PhD
- Email: wmathias@incor.usp.br
- Phone: 5511- 984155556
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.
Conditions: Acute Myocardial Infarction, Unstable Angina, Ultrasound, Sonothrombolysis, Contrast agents, Microbubbles, Microvascular obstruction