High Ultrasound Mechanical Index and MicrobuBBLEs to Reduce Acute Myocardial Infarction Burden I
Status: Recruiting
Location: See all (2) locations...
Intervention Type: Procedure
Study Type: Observational
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 epicardial and microvascular flow in acute ST-segment elevation myocardial infarction (STEMI). The investigators propose to demonstrate the clinical effectiveness of sonothrombolysis in multiple centers and in a wide scenario of acute coronary syndromes.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 30
Healthy Volunteers: f
View:
• 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
Locations
United States
Nebraska
Department of Internal Medicine, Division of Cardiovascular Medicine, University of Nebraska Medical Center
ACTIVE_NOT_RECRUITING
Omaha
Other Locations
Brazil
Heart Institute of Clinical Hospital of Medical School of University of Sao Paulo
RECRUITING
São Paulo
Contact Information
Primary
Wilson Mathias Jr, MD, PhD
wmathias@incor.usp.br
5511- 984155556
Backup
Jeane M Tsutsui, MD, PhD
jeane.tsutsui@incor.usp.br
5511-993806992
Time Frame
Start Date: 2022-02-17
Estimated Completion Date: 2026-02-01
Participants
Target number of participants: 540
Treatments
Subproject 1 - acute STEMI
Participants with acute STEMI will receive intravenous infusion of microbubbles (3% Definity) with therapeutic ultrasound with 4-20 usec and custom designed high mechanical index (MI) impulses (1.1 to 1.3 MI) designed for the 1.8 MHz S5-1 transducer while waiting for percutaneous coronary intervention. Treatment will continue after procedure until complete a total of 50 minutes.
Subproject 2 - acute STEMI initially treated with fibrinolytic
Participants with acute STEMI initially treated with fibrinolytic therapy within 12 hours will receive intravenous infusion of microbubbles (3% Definity) with therapeutic ultrasound with 4-20 usec and custom designed high mechanical index (MI) impulses (1.1 to 1.3 MI) designed for the 1.8 MHz S5-1 transducer while waiting for percutaneous coronary intervention. A control group (PCI only) undergoing low MI (\<0.2) imaging only with limited (no more than 3) diagnostic high MI impulses to assess regional wall motion and microvascular perfusion before and after PCI; High MI will continue after PCI procedure until complete a total of 50 minutes.
Subproject 3 - NSTEMI
Participants with NSTEMI or with high-risk unstable angina will receive intravenous infusion of microbubbles (3% Definity) with therapeutic ultrasound with 4-20 usec and custom designed high mechanical index (MI) impulses (1.1 to 1.3 MI) designed for the 1.8 MHz S5-1 transducer while waiting for percutaneous coronary intervention. A control group (PCI only) undergoing low MI (\<0.2) imaging only with limited (no more than 3) diagnostic high MI impulses to assess regional wall motion and microvascular perfusion before and after PCI. High MI will continue after PCI procedure until complete a total of 50 minutes.
Subproject 4 - No reflow
Participants with acute STEMI will receive intravenous infusion of microbubbles (3% Definity) with therapeutic ultrasound with 4-20 usec and custom designed high mechanical index (MI) impulses (1.1 to 1.3 MI) designed for the 1.8 MHz S5-1 transducer while waiting for percutaneous coronary intervention. A control group (PCI only) undergoing low MI (\<0.2 MI) imaging only with limited (no more than 3) diagnostic high MI impulses to assess regional wall motion and microvascular perfusion before and after PCI. High MI will continue after PCI procedure until complete a total of 50 minutes.
Subproject 6 - Pre-hospital care (ambulance)
Participants with acute STEMI routing from the ambulance to the emergency department will receive intravenous infusion of microbubbles (3% Definity) with therapeutic ultrasound with 4-20 usec and custom designed high mechanical index (MI) impulses (1.1 to 1.3 MI) designed for the 1.8 MHz S5-1 transducer while waiting for percutaneous coronary intervention. A control group (PCI only) undergoing low MI (\<0.2) imaging only with limited (no more than 3) diagnostic high MI impulses to assess regional wall motion and microvascular perfusion before and after PCI. High MI will continue after PCI procedure until complete a total of 50 minutes.
Related Therapeutic Areas
Sponsors
Leads: University of Sao Paulo General Hospital
Collaborators: University of Nebraska