Status:
RECRUITING
Therapeutic Use of Contrast Ultrasound in Acute Coronary Artery Disease
Lead Sponsor:
University of Sao Paulo General Hospital
Collaborating Sponsors:
University of Nebraska
Conditions:
Acute Myocardial Infarction
Unstable Angina
Eligibility:
All Genders
30+ years
Brief Summary
Preclinical studies have demonstrated that high mechanical index (MI) impulses from a diagnostic ultrasound (DUS) transducer during an intravenous microbubble infusion (sonothrombolysis) can restore e...
Detailed Description
Initial safety and feasibility human studies demonstrated that intermittent high MI aimed at the myocardial microcirculation could improve capillary blood flow within the risk area and epicardial reca...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
February 17 2022
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
February 1 2026
Estimated Enrollment :
540 Patients enrolled
Trial Details
Trial ID
NCT04732091
Start Date
February 17 2022
End Date
February 1 2026
Last Update
October 10 2023
Active Locations (2)
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1
Department of Internal Medicine, Division of Cardiovascular Medicine, University of Nebraska Medical Center
Omaha, Nebraska, United States, 68198
2
Heart Institute of Clinical Hospital of Medical School of University of Sao Paulo
São Paulo, Brazil, 05403900