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Unlikely to demonstrate the intended benefit within the planned study design and statistical framework.
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| Name | Class |
|---|---|
| Canadian VIGOUR Centre | OTHER |
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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
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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Sonothrombolysis | Experimental | Diagnostic myocardial contrast echocardiography with ultrasound contrast agent 5% Definity® plus Sonothrombolysis |
|
| Standard of Care | No Intervention | Diagnostic myocardial contrast echocardiography with ultrasound contrast agent 5% Definity® |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Definity® with High Mechanical Index Ultrasound | Drug | Sonothrombolysis; Echocardiographic imaging with intermittent diagnostic high mechanical index during an intravenous 5% Definity® infusion |
| Measure | Description | Time Frame |
|---|---|---|
| Complete ST-Segment Resolution | ST-segment recovery as assessed by complete ST-segment resolution (>50%) | 90 minutes post TNK administration |
| Measure | Description | Time Frame |
|---|---|---|
| Frequency of rescue/urgent PCI | Frequency of rescue/urgent PCI following the administration of fibrinolysis. | approximately 3-24 hours post TNK administration |
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Composite of death/shock, heart failure/new myocardial infarction in hospital | Composite of death/shock, heart failure/new myocardial infarction in hospital | Until hospital discharge, approximately 5 days |
| Composite of death/shock, heart failure/new myocardial infarction at 1-year |
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:
Age >30 years
Adequate apical and/or parasternal images by echocardiography
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Alberta | Edmonton | Alberta | Canada |
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| ID | Term |
|---|---|
| D000072657 | ST Elevation Myocardial Infarction |
| ID | Term |
|---|---|
| D009203 | Myocardial Infarction |
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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| ID | Term |
|---|---|
| C042852 | perflutren |
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| approximately 30 minutes post TNK administration |
| 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 | approximately 30 minutes post TNK administration |
| 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. | 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 | Day 1 (pre reperfusion), Day 3 +/-2d (hospital discharge), and Day 90 +/-2d after infarction. |
| 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:
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 | Day 1 (pre reperfusion), Day 3 +/-2d (hospital discharge), and Day 90 +/-2d after infarction. |
| 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. | Day 1 (pre reperfusion), Day 3 +/-2d (hospital discharge), and Day 90 +/-2d after infarction. |
| 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. | Day 3 +/-2d (hospital discharge) |
Composite of death/shock, heart failure/new myocardial infarction at 1-year |
| 1 year |
| TIMI flow grade pre and post PCI on index angiogram | TIMI flow grade pre and post PCI on index angiogram | pre and post PCI on index angiogram, approximately 3-24 hours post TNK administration |
| D014652 |
| Vascular Diseases |
| D007238 | Infarction |
| D007511 | Ischemia |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D009336 | Necrosis |