Sonothrombolysis in Patients With STEMI
Condition: ST-segment Elevation Myocardial Infarction
MeSH terms: Myocardial Infarction; ST Elevation Myocardial Infarction; Infarction
Intervention: Definity, (Lipid Microspheres) Intravenous Suspension; Myocardial Contrast Echocardiography; Repurfusion therapy with PPCI
Intervention description: Sonothrombolysis (High Impulse therapeutic ultrasound with infusion of ultrasound contrast agent Definity) will be applied before and after standard of care reperfusion therapy with PPCI; Myocardial contrast echocardiography will be applied before standard of care reperfusion therapy as well as prior to discharge and at 3 month follow up; Patients will receive reperfusion therapy with PPCI as standard of care
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Intervention model description: This clinical study is a prospective single-center, single-arm investigation of sonothrombolysis in adult patients presenting with high-risk STEMI within 6 hrs of the onset of clinical symptoms and receiving reperfusion therapy with PCI. All patients will receive standard therapy. Patients will immediately receive an iv infusion of commercially available ultrasound contrast agent (Definity) and myocardial contrast echocardiography will be performed to document the size of the perfusion defect. Loops of 15 cardiac cycles will be recorded using low mechanical index (MI) ultrasound. These recordings will also be used to assess regional wall motion as well as LV volumes and ejection fraction. Immediately after the diagnostic ultrasound, the therapeutic ultrasound will start using the same transducer by applying multiple high MI ultrasound impulses. These pulses will be applied to the apical windows that contained the risk area. The intervals between HMI impulses will vary from 5 to 15 s.
Masking: None (Open Label)
Enrollment: 15.0
Sex: All
Minimum age: 30 Years
Healthy volunteers: No
Keywords: Sonothrombolysis, STEMI, PPCI, Microbubbles

Summary:

      This study evaluates what effect sonothrombolysis may have on spontaneous reperfusion,
      microvascular obstruction, left ventricular function and infarct size in patients presenting
      with their first ST-segment Elevation Myocardial Infarction.
    

Eligibility criteria:

        Inclusion Criteria:

        Patients presenting with STEMI within 6 hours of symptom onset and:

          1. Are expected to receive reperfusion therapy with primary PCI

          2. Have a high-risk STEMI ECG defined as:

               -  ≥2mm ST-segment elevation in 2 anterior or lateral leads; or

               -  ≥2 mm 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.