Sonothrombolysis in Patients With STEMI

Enrollment

15 participants (actual enrollment reported by the registry).

Study Design

Study Type

interventional

Phase

phase 2

Allocation

NA

Masking

NONE

Purpose

TREATMENT

Intervention Model

SINGLE GROUP

Model Details: 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.

Sponsor Type

OTHER

Responsible Party

SPONSOR INVESTIGATOR

PI Title

Professor of Medicine

Study Record Dates