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Completed

NCT Number: NCT02170103

Microvascular Recovery With Ultrasound in Myocardial Infarction (MRUSMI) Post PCI Trial

The investigators propose to test the effectiveness of a technique that uses a modified commercially available ultrasound system used for cardiac imaging, and a commercially available ultrasound contrast agent (microbubbles) to break up the blood clots that cause heart attacks. The ultrasound and microbubbles will be applied as soon as possible to patients presenting to the emergency department, after an EKG confirms that a heart attack is ongoing. Patients who provide emergent consent will be randomized to either conventional therapy for a heart attack, or conventional therapy and ultrasound with microbubbles. The ultrasound will be applied both before and after emergent heart catheterization, in order to break up the blood clots that are not only in the artery supplying the heart muscle, but also in the small branches (capillaries) that are fed by this artery. Following the randomized treatment, patients will be followed for the development of any complications (recurrent heart attack, heart failure, or need for defibrillator placement) as well as by echo and cardiac MRI to determine how much heart muscle was salvaged by the treatment.

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Key information

Conditions

STEMI Cardiovascular Diseases Chest Pain Heart Diseases Infarction Ischemia Myocardial Infarction Myocardial Ischemia Necrosis Neurologic Manifestations Pain Pathologic Processes Pathological Conditions, Signs and Symptoms ST Elevation Myocardial Infarction Signs and Symptoms Vascular Diseases

Age range

30 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Sao Paulo Medical Center, São Paulo, Brazil

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About this study

The investigators propose to test the effectiveness of a technique that uses a modified commercially available ultrasound system used for cardiac imaging, and a commercially available ultrasound contrast agent (microbubbles) to break up the blood clots that cause heart attacks. The ultrasound and microbubbles will be applied as soon as possible to patients presenting to the emergency department, after an EKG confirms that a heart attack is ongoing. Patients who provide emergent consent will be randomized to either conventional therapy for a heart attack, or conventional therapy and ultrasound with microbubbles. The ultrasound will be applied both before and after emergent heart catheterization, in order to break up the blood clots that are not only in the artery supplying the heart muscle, but also in the capillaries that are fed by this artery. Following the randomized treatment, patients will be followed for the development of any complications (recurrent heart attack, heart failure, or need for defibrillator placement) as well as by echo and cardiac MRI to determine how much heart muscle was salvaged by the treatment. A total of 250 patients will be enrolled and followed at two different sites. Randomization will be stratified at each study site. The initial site enrolling patients will be University of Sao Paulo Medical School. The other is Vrije Universiteit (VU) University Medical Center in Amsterdam.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patients presenting to participating centers with chest pain and EKG evidence of an acute STEMI (two contiguous leads with >0.1 millivolt (mV) ST elevation or >0.1 ST depression in V2-V4) will be asked to participate. The inclusion criteria will be:
  • Age ≥30 years.
  • Eligible for emergent PCI/antithrombotic/antiplatelet therapy.
  • Adequate apical and/or parasternal images by echocardiography.
  • 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 severe cardiomyopathy.
  • Known bleeding diathesis or contraindication to glycoprotein 2b/3a inhibitors, anticoagulants, or aspirin
  • Known large right to left intracardiac shunts.

Treatment and study plan

percutaneous intervention (PCI)

Procedure

Successful PCI with the patent vessel and at least Thrombolysis in Myocardial Infarction (TIMI) 2 flow in the left anterior descending artery (LAD) post-PCI.

Microbubbles

Drug

The agents will be divided into two separate doses (two vials per study), and mixed with approximately 29 milliliters of saline (approximately a 2.0-4.0% infusion). The first dilution will be administered pre PCI therapy, and the second dilution infused immediately post PCI. Since Optison is less stable in saline, an alternative approach will be to give the Optison as intermittent 0.1 milliliter boluses followed by 3-5 saline flushes over 10 seconds. The entire duration of each treatment before PCI will be up to 30 minutes depending on time constraints in getting to the catheterization laboratory, while the duration of treatment immediately after PCI will be 30 minutes.

Other names: DEFINITY® (Perflutren Lipid Microsphere) manufactured by Lantheus Medical Imaging, OPTISON™ (Perflutren Protein-Type A Microspheres Injectable Suspension, USP) manufactured by General Electric Global Research

Ultrasound

Procedure

Intermittent high Mechanical Index (MI) impulses (0.8-1.4 MI; Frequency 1.0-1.7 MegaHertz (MHz); pulse duration 4-44 microseconds) will be administered over the microvasculature where there are wall motion abnormalities and a perfusion defect using an imaging plane that best aligns itself with the risk area

Primary outcomes

  1. Six month event free survival (EFS)

    Time frame: 6 months

    The time from the start of treatment to first cardiac event or death as a first event. Cardiac events include, congestive heart failure, life threatening arrhythmias, and need for prophylactic defibrillator (primary and secondary).

  2. Myocardial salvageability index

    Time frame: Prior to hospital discharge (48-72 hours)

    The difference between extent of delayed enhancement by Gd MRI and the T2 weighted double or triple inversion spin echo assessment of risk area (defined above).

  3. Frequency of left ventricular remodeling

    Time frame: 6 month follow-up

    Defined as a 20% increase in end diastolic volume at the six month follow up biplane contrast enhanced echocardiogram compared to the pre-discharge contrast enhanced echocardiogram

Secondary outcomes

  1. Safety of contrast in this setting

    Time frame: at the time of procedure to 6 month follow-up

    Assessed by any alterations on oxygen saturation or hemodynamic effects acutely related to ultrasound contrast administration

  2. Frequency of > 50% ST segment resolution by EKG at six hours post PCI.

    Time frame: 6 hours post PCI

    Frequency of > 50% ST segment, (a key indicator for both myocardial ischaemia and necrosis if it goes up or down) resolution by EKG at six hours post PCI.

  3. Area under the Creatine Phosphokinase (CPK) versus time curve

    Time frame: at time of procedure

    Quantifies infarct size

  4. Overall survival (OS)

    Time frame: From date of randomization until the date of first documented progression or date of death from any cause, whichever comes first, assessed up to 120 months

    Defined as the time from the start of randomized treatment to death from any cause.

Sponsors and collaborators

Lead sponsor

University of Nebraska

Other

Collaborators

  • InCor Heart Institute
  • VU University of Amsterdam

Registry information

Official study title

Effect of Diagnostic Echocardiogram on Microvascular Recovery Following Acute STEMI

Acronym: MRUSMI

Important dates

Study start
2018
Primary completion
2023
Study completion
2023
First posted
Jun 23, 2014
Registry last updated
Oct 31, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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