Therapeutic Use of Ultrasound in Acute Coronary Artery Disease

NCT02410330 | Completed DMC

• 1 other identifier: SDC 3562/10/151
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

In acute coronary artery disease, pre-clinical studies have indicated that, during a continuous infusion of intravenous perfluorocarbon containing microbubbles, the ultrasonic power delivered from a diagnostic ultrasound transducer is capable of restoring microcirculatory flow and improving epicardial recanalization rates obtained by conventional therapy, a process known by Sonothrombolysis. The investigators proposed to examine the feasibility, safety and efficacy of such an ultrasound guided approach in 100 patients with ST segment elevation myocardial infarction (STEMI).

Conditions

Acute Myocardial Infarction

Keywords

Therapeutic ultrasound; Angiographic recanalization rate; Salvagability index; Sonothrombolysis

Outcome Measures

Primary Outcomes (1)

• Angiographic recanalization rate

  Percentage of patients with acute STEMI and open artery at initial angiography (TIMI I)

  At initial angiography

Secondary Outcomes (3)

• Salvagability index

  72-96 hours post infarction

• Overall survival

  30 days post infarction

• Left ventricular function and perfusion parameters

  72-96 hours and at 6 months

Study Arms (3)

Group I

Patients with acute STEMI will receive intravenous infusion of microbubbles (3% Definity) with Therapeutic ultrasound with 20 usec: custom designed high mechanical index (MI) impulses at 4-20 usec and \>1.0 MI designed for the 1.7 MHz S5-1 transducer while waiting for percutaneous coronary intervention. Treatment will continue after procedure untill complete a total of 60 minutes.

Procedure: Therapeutic ultrasound with 20 usec

Group II

Patients with acute STEMI will receive intravenous infusion of microbubbles (3% Definity) with therapeutic ultrasound with repeated diagnostic high mechanical index impulses (all \<2 usec pulse duration; MI=1.0) whenever very low MI perfusion imaging detected microbubbles within the microvasculature. Treatment will be applied while patient waits for percutaneous coronary intervention. Treatment will continue after procedure untill complete a total of 60 minutes.

Procedure: Repeated diagnostic high mechanical index

Group III

Patients with acute STEMI will receive intravenous infusion of microbubbles (3% Definity) while few limited diagnostic high MI impulses (n\<5 per patient) will be applied to assess myocardial perfusion before and after percutaneous coronary intervention (PCI).

Interventions

Therapeutic ultrasound with 20 usec PROCEDURE

A custom designed high mechanical index (MI) impulses at 4-20 usec and \>1.0 mechanical index designed for the 1.7 MHz S5-1 transducer

Group I

Repeated diagnostic high mechanical index PROCEDURE

Repeated diagnostic high mechanical index impulses (all \<2 usec pulse duration; MI=1.0) whenever very low mechanical index perfusion imaging detected microbubbles within the microvasculature

Group II

Eligibility Criteria

• Age: 30 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with acute ST elevation myocardial infarction (STEMI) with less than 12 hours of chest pain onset, eligible for emergent percutaneous coronary intervention therapy.

You may qualify if:

• Age ≥30 years with STEMI with less than 12 hours of chest pain onset.
• Eligible for emergent PCI therapy.
• No contraindications or hypersensitivities to ultrasound contrast agents

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Sao Paulo General Hospital: lead
• University of Nebraska: collaborator

Study Sites (1)

Heart Institute (InCor)

São Paulo, 05403000, Brazil

Location

Related Publications (3)

• Mathias W Jr, Tsutsui JM, Tavares BG, Fava AM, Aguiar MOD, Borges BC, Oliveira MT Jr, Soeiro A, Nicolau JC, Ribeiro HB, Chiang HP, Sbano JCN, Morad A, Goldsweig A, Rochitte CE, Lopes BBC, Ramirez JAF, Kalil Filho R, Porter TR; MRUSMI Investigators. Sonothrombolysis in ST-Segment Elevation Myocardial Infarction Treated With Primary Percutaneous Coronary Intervention. J Am Coll Cardiol. 2019 Jun 11;73(22):2832-2842. doi: 10.1016/j.jacc.2019.03.006. Epub 2019 Mar 17.

  PMID: 30894317 RESULT

• Aguiar MOD, Tavares BG, Tsutsui JM, Fava AM, Borges BC, Oliveira MT Jr, Soeiro A, Nicolau JC, Ribeiro HB, Chiang HP, Sbano JCN, Goldsweig A, Rochitte CE, Lopes BBC, Ramirez JAF, Kalil Filho R, Porter TR, Mathias W Jr. Sonothrombolysis Improves Myocardial Dynamics and Microvascular Obstruction Preventing Left Ventricular Remodeling in Patients With ST Elevation Myocardial Infarction. Circ Cardiovasc Imaging. 2020 Apr;13(4):e009536. doi: 10.1161/CIRCIMAGING.119.009536. Epub 2020 Apr 21.

  PMID: 32312114 RESULT

• Mathias W Jr, Tsutsui JM, Tavares BG, Xie F, Aguiar MO, Garcia DR, Oliveira MT Jr, Soeiro A, Nicolau JC, Lemos PA Neto, Rochitte CE, Ramires JA, Kalil R Filho, Porter TR. Diagnostic Ultrasound Impulses Improve Microvascular Flow in Patients With STEMI Receiving Intravenous Microbubbles. J Am Coll Cardiol. 2016 May 31;67(21):2506-15. doi: 10.1016/j.jacc.2016.03.542.

  PMID: 27230046 DERIVED

Biospecimen

Retention: SAMPLES WITH DNA

Blood sample

MeSH Terms

Interventions

Ultrasonic Therapy

Intervention Hierarchy (Ancestors)

Diathermy; Hyperthermia, Induced; Therapeutics

Study Officials

• Wilson Mathias Jr, MD

  Heart Institute - University of São Paulo Medical School

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Target Duration: 6 Months
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director Echocardiography Laboratory - Heart Institute

Study Record Dates

• First Submitted: April 1, 2015
• First Posted: April 7, 2015
• Study Start: May 1, 2014
• Primary Completion: January 1, 2020
• Study Completion: January 1, 2020
• Last Updated: December 8, 2021

Record last verified: 2021-11

Data Sharing

• IPD Sharing: Will not share

Locations

BR (1)