Therapeutic Use of Ultrasound in Acute Coronary Artery Disease

November 24, 2021 updated by: Wilson Mathias Junior, University of Sao Paulo General Hospital
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).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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. Since both diagnostic ultrasound and intravenous infusions of microbubbles are a Class I indication to assess regional and global left ventricular function and risk area in patients with ST segment elevation myocardial infarction (STEMI). The investigators propose to examine the effectiveness of microvascular sonothrombolysis.

A total of 100 patients with acute STEMI will be randomized to receive diagnostic ultrasound guided high mechanical index (MI) impulses in different approaches applied within and outside the risk area during a continuous infusion of intravenous 3% Definity® or placebo. The different ultrasound regimens are: Group I - a custom designed high mechanical index (MI) impulses at 4-20 usec and >1.0 MI designed for the 1.7 MHz S5-1 transducer; Group II - repeated diagnostic high MI impulses (all <2 usec pulse duration; MI=1.0 whenever very low MI perfusion imaging detected microbubbles within the microvasculature; Group III (control), where a few limited diagnostic high MI impulses (n<5 per patient) will be applied to assess myocadial perfusion before and after percutaneous coronary intervention (PCI). All patients will receive the conventional PCI approach, including 325 milligrams Aspirin, 600 milligrams Clopidogrel, and heparin bolus (5000 units), followed by primary PCI using glycoprotein 2b/3a inhibitors as anti-thrombotic agents using established protocols. Besides angiographic recanalization rates at the time of presentation to the catheterization laboratory, the patients will have a magnetic resonance exam performed at 72-96 hours post infarcton to quantify the myocardial salvagability index. Quantitative assessments of ejection fraction will be made at this time as well.Overall survival (OS), defined as the time from the start of treatment to death from any cause, will be evaluated.Comparisons between the three groups will be made on door to dilation times, survival, angiographic recanalization rates (ARR) at initial angiography, and reduction in infarct size determined by the salvagability index (SI) at magnetic resonance imaging 72-96 hours post STEMI. Left ventricular function and perfusion parameters by echocardiography will also be evaluated during, at 72-96 hours and at 6 months in all subjects.

Study Type

Observational

Enrollment (Actual)

100

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Brazil
      • São Paulo, Brazil, 05403000
        • Heart Institute (InCor)

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

30 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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.

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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
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 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
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 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).

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Angiographic recanalization rate
Time Frame: At initial angiography
Percentage of patients with acute STEMI and open artery at initial angiography (TIMI I)
At initial angiography

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Overall survival
Time Frame: 30 days post infarction
The time from the start of treatment to death from any cause
30 days post infarction
Salvagability index
Time Frame: 72-96 hours post infarction
Percentage of myocardium with viability within the risk area obtained by magnetic ressonance imaging
72-96 hours post infarction
Left ventricular function and perfusion parameters
Time Frame: 72-96 hours and at 6 months
left ventricular volumes, ejection fraction, longitudinal strain, diastolic function and infarct size by myocardial contrast echocardiography
72-96 hours and at 6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Sao Paulo General Hospital

Collaborators

University of Nebraska

Investigators

  • Principal Investigator: Wilson Mathias Jr, MD, Heart Institute - University of São Paulo Medical School

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2014

Primary Completion (Actual)

January 1, 2020

Study Completion (Actual)

January 1, 2020

Study Registration Dates

First Submitted

April 1, 2015

First Submitted That Met QC Criteria

April 1, 2015

First Posted (Estimate)

April 7, 2015

Study Record Updates

Last Update Posted (Actual)

December 8, 2021

Last Update Submitted That Met QC Criteria

November 24, 2021

Last Verified

November 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SDC 3562/10/151

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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