Back to resultsSONOthrombolysis in Patients With an ST-segment Elevation Myocardial Infarction With fibrinoLYSIS (SONOSTEMI-LYSIS) Trial (SONOSTEMILYSIS)
Primary Purpose
ST Elevation Myocardial Infarction
Status
Recruiting
Phase
Phase 2
Locations
Canada
Study Type
Interventional
Intervention
Definity® with High Mechanical Index Ultrasound
Sponsored by
About this trial
This is an interventional treatment trial for ST Elevation Myocardial Infarction
Eligibility Criteria
Inclusion Criteria:
Patients presenting with STEMI within 6 hours of symptom onset and:
- Are expected to receive reperfusion therapy with fibrinolysis
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
- Age >30 years
- 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
Sites / Locations
- University of AlbertaRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Sonothrombolysis
Standard of Care
Arm Description
Diagnostic myocardial contrast echocardiography with ultrasound contrast agent 5% Definity® plus Sonothrombolysis
Diagnostic myocardial contrast echocardiography with ultrasound contrast agent 5% Definity®
Outcomes
Primary Outcome Measures
Complete ST-Segment Resolution
ST-segment recovery as assessed by complete ST-segment resolution (>50%)
Secondary Outcome Measures
Frequency of rescue/urgent PCI
Frequency of rescue/urgent PCI following the administration of fibrinolysis.
ST-segment resolution (>50%)
ST-segment resolution (>50%) following a pharmacoinvasive approach at ~30 minutes post PCI as assessed by the worst lead on electrocardiogram
ST-segment resolution (continuous)
ST-segment resolution (continuous) following a pharmacoinvasive approach at ~30 minutes post PCI as assessed by the worst lead on electrocardiogram
Left ventricular ejection fraction
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.
Wall motion score index (WMSI)
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
Microvascular perfusion score index (MPSI)
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:
normal, contrast replenishment within 4 seconds
mildly reduced, contrast replenishment takes longer than 4 seconds
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
Global Longitudinal Strain (GLS)
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.
QRS Score
Selvester QRS Scoring System, assessed on Day 3 +/-2d (hospital discharge) ECG. Minimum score 0, Maximum score 32. Higher score indicates worse outcome.
Full Information
NCT ID
NCT04217304
First Posted
January 2, 2020
Last Updated
May 16, 2023
Sponsor
University of Alberta
Collaborators
Canadian VIGOUR Centre
1. Study Identification
Unique Protocol Identification Number
NCT04217304
Brief Title
SONOthrombolysis in Patients With an ST-segment Elevation Myocardial Infarction With fibrinoLYSIS (SONOSTEMI-LYSIS) Trial
Acronym
SONOSTEMILYSIS
Official Title
SONOthrombolysis in Patients With an ST-segment Elevation Myocardial Infarction With fibrinoLYSIS (SONOSTEMI-LYSIS) Trial
Study Type
Interventional
2. Study Status
Record Verification Date
May 2023
Overall Recruitment Status
Recruiting
Study Start Date
February 23, 2021 (Actual)
Primary Completion Date
May 1, 2025 (Anticipated)
Study Completion Date
May 1, 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Alberta
Collaborators
Canadian VIGOUR Centre
4. Oversight
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
5. Study Description
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
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
ST Elevation Myocardial Infarction
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
60 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Sonothrombolysis
Arm Type
Experimental
Arm Description
Diagnostic myocardial contrast echocardiography with ultrasound contrast agent 5% Definity® plus Sonothrombolysis
Arm Title
Standard of Care
Arm Type
No Intervention
Arm Description
Diagnostic myocardial contrast echocardiography with ultrasound contrast agent 5% Definity®
Intervention Type
Drug
Intervention Name(s)
Definity® with High Mechanical Index Ultrasound
Intervention Description
Sonothrombolysis; Echocardiographic imaging with intermittent diagnostic high mechanical index during an intravenous 5% Definity® infusion
Primary Outcome Measure Information:
Title
Complete ST-Segment Resolution
Description
ST-segment recovery as assessed by complete ST-segment resolution (>50%)
Time Frame
90 minutes post TNK administration
Secondary Outcome Measure Information:
Title
Frequency of rescue/urgent PCI
Description
Frequency of rescue/urgent PCI following the administration of fibrinolysis.
Time Frame
approximately 3-24 hours post TNK administration
Title
ST-segment resolution (>50%)
Description
ST-segment resolution (>50%) following a pharmacoinvasive approach at ~30 minutes post PCI as assessed by the worst lead on electrocardiogram
Time Frame
approximately 30 minutes post TNK administration
Title
ST-segment resolution (continuous)
Description
ST-segment resolution (continuous) following a pharmacoinvasive approach at ~30 minutes post PCI as assessed by the worst lead on electrocardiogram
Time Frame
approximately 30 minutes post TNK administration
Title
Left ventricular ejection fraction
Description
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.
Time Frame
Day 1 (pre reperfusion), Day 3 +/-2d (hospital discharge), and Day 90 +/-2d after infarction.
Title
Wall motion score index (WMSI)
Description
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
Time Frame
Day 1 (pre reperfusion), Day 3 +/-2d (hospital discharge), and Day 90 +/-2d after infarction.
Title
Microvascular perfusion score index (MPSI)
Description
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:
normal, contrast replenishment within 4 seconds
mildly reduced, contrast replenishment takes longer than 4 seconds
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
Time Frame
Day 1 (pre reperfusion), Day 3 +/-2d (hospital discharge), and Day 90 +/-2d after infarction.
Title
Global Longitudinal Strain (GLS)
Description
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.
Time Frame
Day 1 (pre reperfusion), Day 3 +/-2d (hospital discharge), and Day 90 +/-2d after infarction.
Title
QRS Score
Description
Selvester QRS Scoring System, assessed on Day 3 +/-2d (hospital discharge) ECG. Minimum score 0, Maximum score 32. Higher score indicates worse outcome.
Time Frame
Day 3 +/-2d (hospital discharge)
Other Pre-specified Outcome Measures:
Title
Composite of death/shock, heart failure/new myocardial infarction in hospital
Description
Composite of death/shock, heart failure/new myocardial infarction in hospital
Time Frame
Until hospital discharge, approximately 5 days
Title
Composite of death/shock, heart failure/new myocardial infarction at 1-year
Description
Composite of death/shock, heart failure/new myocardial infarction at 1-year
Time Frame
1 year
Title
TIMI flow grade pre and post PCI on index angiogram
Description
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Patients presenting with STEMI within 6 hours of symptom onset and:
Are expected to receive reperfusion therapy with fibrinolysis
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
Age >30 years
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
Facility Information:
Facility Name
University of Alberta
City
Edmonton
State/Province
Alberta
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kevin Bainey, MD
Phone
780-407-2176
Email
Kevin.Bainey@albertahealthservices.ca
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
SONOthrombolysis in Patients With an ST-segment Elevation Myocardial Infarction With fibrinoLYSIS (SONOSTEMI-LYSIS) Trial
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