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SONOthrombolysis in Patients With an ST-segment Elevation Myocardial Infarction With fibrinoLYSIS (SONOSTEMI-LYSIS) Trial (SONOSTEMILYSIS)

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ClinicalTrials.gov Identifier: NCT04217304
Recruitment Status : Not yet recruiting
First Posted : January 3, 2020
Last Update Posted : April 6, 2020
Sponsor:
Collaborator:
Canadian VIGOUR Centre
Information provided by (Responsible Party):
Kevin Bainey, University of Alberta

Brief Summary:
This study will assess the safety and feasibility of sonothrombolysis in the acute management of STEMI undergoing reperfusion therapy with systemic fibrinolysis as part of a pharmacoinvasive approach

Condition or disease Intervention/treatment Phase
ST Elevation Myocardial Infarction Drug: Definity® with High Mechanical Index Ultrasound Phase 2

Detailed Description:

This study is an open label, single-centre, randomized investigation of sonothrombolysis in 60 adult patients presenting with STEMI within 6 hours of the onset of clinical symptoms and receiving perfusion therapy with fibrinolysis as part of a pharmacoinvasive strategy.

Patients will be randomized 2:1 to either adjunct treatment with sonothrombolysis or standard therapy alone according to the current American College of Cardiology/American Heart Association (ACC/AHA) or European Society of Cardiology (ESC) STEMI and PCI guidelines. All patients will receive serial echocardiography assessments during and after reperfusion with the final ECHO assessment at 90 days (+/- 7d) post reperfusion. Patient outcomes (medical records review) will be followed for 1 year after reperfusion.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: SONOthrombolysis in Patients With an ST-segment Elevation Myocardial Infarction With fibrinoLYSIS (SONOSTEMI-LYSIS) Trial
Estimated Study Start Date : September 1, 2020
Estimated Primary Completion Date : March 1, 2023
Estimated Study Completion Date : March 1, 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Attack
Drug Information available for: Perflutren

Arm Intervention/treatment
Experimental: Sonothrombolysis
Diagnostic myocardial contrast echocardiography with ultrasound contrast agent 5% Definity® plus Sonothrombolysis
Drug: Definity® with High Mechanical Index Ultrasound
Sonothrombolysis; Echocardiographic imaging with intermittent diagnostic high mechanical index during an intravenous 5% Definity® infusion

No Intervention: Standard of Care
Diagnostic myocardial contrast echocardiography with ultrasound contrast agent 5% Definity®



Primary Outcome Measures :
  1. Complete ST-Segment Resolution [ Time Frame: 90 minutes post TNK administration ]
    ST-segment recovery as assessed by complete ST-segment resolution (>50%)


Secondary Outcome Measures :
  1. Frequency of rescue/urgent PCI [ Time Frame: approximately 3-24 hours post TNK administration ]
    Frequency of rescue/urgent PCI following the administration of fibrinolysis.

  2. ST-segment resolution (>50%) [ Time Frame: approximately 30 minutes post TNK administration ]
    ST-segment resolution (>50%) following a pharmacoinvasive approach at ~30 minutes post PCI as assessed by the worst lead on electrocardiogram

  3. ST-segment resolution (continuous) [ Time Frame: approximately 30 minutes post TNK administration ]
    ST-segment resolution (continuous) following a pharmacoinvasive approach at ~30 minutes post PCI as assessed by the worst lead on electrocardiogram

  4. Left ventricular ejection fraction [ Time Frame: Day 1 (pre reperfusion), Day 3 +/-2d (hospital discharge), and Day 90 +/-2d after infarction. ]
    Left ventricular ejection fraction by ECHO (Simpson method) assessed on Day 1 (pre reperfusion), Day 3 +/-2d (hospital discharge), and Day 90 +/-2d after infarction.

  5. Wall motion score index (WMSI) [ Time Frame: Day 1 (pre reperfusion), Day 3 +/-2d (hospital discharge), and Day 90 +/-2d after infarction. ]

    Wall motion score index (WMSI) by ECHO assessed on Day 1 (pre reperfusion), Day 3 +/-2d (hospital discharge), and Day 90 +/-2d after infarction.

    Each of the 17 LV segments is classified as:

    1 normal 2.hypokinetic 3.akinetic 4.dyskinetic The WMS index is the sum of the scores divided by the number of segments. Usually 17, but if a segment cannot be classified, the sum is divided by the number of readable segments.

    Minimum value is 1 : all segments are normal - best outcome Maximum value is 4: all segments are dyskinetic - worst outcome


  6. Microvascular perfusion score index (MPSI) [ Time Frame: Day 1 (pre reperfusion), Day 3 +/-2d (hospital discharge), and Day 90 +/-2d after infarction. ]

    Microvascular perfusion score index (MPSI) by ECHO assessed on Day 1 (pre reperfusion), Day 3 +/-2d (hospital discharge), and Day 90 +/-2d after infarction

    Each of the 17 LV segments is classified as:

    1. normal, contrast replenishment within 4 seconds
    2. mildly reduced, contrast replenishment takes longer than 4 seconds
    3. no contrast replenishment over 10 seconds

    The MPSI index is the sum of the scores divided by the number of segments. Usually 17, but if a segment cannot be classified, then the sum is divided by the number of readable segments

    Minimum value is 1 : all segments are normal - best outcome Maximum value is 3: all segments are not perfused - worst outcome


  7. Global Longitudinal Strain (GLS) [ Time Frame: Day 1 (pre reperfusion), Day 3 +/-2d (hospital discharge), and Day 90 +/-2d after infarction. ]

    Global Longitudinal Strain (GLS) by ECHO assessed on Day 1 (pre reperfusion), Day 3 +/-2d (hospital discharge), and Day 90 +/-2d after infarction

    GLS is measured using speckle tracking imaging (Epiq, Philips). The scale is - % which means percentage of longitudinal shortening of myocardial segments. Similar to the WMSI, GLS is calculated by dividing the sum of the longitudinal strain measurements in the myocardial segments segments by the number of segments which can be assessed by speckle tracking (18 when all segments in all 3 apical views can be analysed.

    The lower the absolute strain value the worse the LV function.


  8. QRS Score [ Time Frame: Day 3 +/-2d (hospital discharge) ]
    Selvester QRS Scoring System, assessed on Day 3 +/-2d (hospital discharge) ECG. Minimum score 0, Maximum score 32. Higher score indicates worse outcome.


Other Outcome Measures:
  1. Composite of death/shock, heart failure/new myocardial infarction in hospital [ Time Frame: Until hospital discharge, approximately 5 days ]
    Composite of death/shock, heart failure/new myocardial infarction in hospital

  2. Composite of death/shock, heart failure/new myocardial infarction at 1-year [ Time Frame: 1 year ]
    Composite of death/shock, heart failure/new myocardial infarction at 1-year

  3. TIMI flow grade pre and post PCI on index angiogram [ Time Frame: pre and post PCI on index angiogram, approximately 3-24 hours post TNK administration ]
    TIMI flow grade pre and post PCI on index angiogram



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients presenting with STEMI within 6 hours of symptom onset and:

    1. Are expected to receive reperfusion therapy with fibrinolysis
    2. Have a high-risk STEMI ECG as defined as:

      • >2mm ST-segment elevation in 2 anterior or lateral leads; or
      • >2mm ST-segment elevation in 2 inferior leads coupled with ST-segment depression in 2 contiguous anterior leads for a total ST-segment deviation of >4mm
    3. Age >30 years
    4. Adequate apical and/or parasternal images by echocardiography

Exclusion Criteria:

  • 1. Isolated inferior STEMI without anterior ST-segment depression 2. Previous coronary bypass surgery 3. Cardiogenic shock 4. Known or suspected hypersensitivity to ultrasound contrast agent used for the study 5. Life expectancy of less than two months or terminally ill 6. Known bleeding diathesis or contraindication to glycoprotein 2b/3a inhibitors, anticoagulants, or aspirin 7. Known large right to left intracardiac shunts 8. Patient received another investigational medication or treatment within 30 days prior to presentation with STEMI
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Responsible Party: Kevin Bainey, Interventional Cardiologist, Associate Professor, University of Alberta
ClinicalTrials.gov Identifier: NCT04217304    
First Posted: January 3, 2020    Key Record Dates
Last Update Posted: April 6, 2020
Last Verified: April 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: Yes
Additional relevant MeSH terms:
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Myocardial Infarction
ST Elevation Myocardial Infarction
Infarction
Ischemia
Pathologic Processes
Necrosis
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases