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

ST Elevation Myocardial Infarction Clinical Trial

— SONOSTEMILYSIS  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04217304
• Other study ID #: Pro00093814
• Status: Recruiting
• Phase: Phase 2
• Start date: February 23, 2021
• Est. completion date: May 1, 2025

Study information

• Verified date: May 2024
• Source: University of Alberta
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: May 1, 2025
• Est. primary completion date: May 1, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Infarction
• Myocardial Infarction
• ST Elevation Myocardial Infarction

Intervention

Drug:
• Definity® with High Mechanical Index Ultrasound
Sonothrombolysis; Echocardiographic imaging with intermittent diagnostic high mechanical index during an intravenous 5% Definity® infusion

Locations

Country	Name	City	State
Canada	University of Alberta	Edmonton	Alberta

Sponsors (2)

Lead Sponsor	Collaborator
University of Alberta	Canadian VIGOUR Centre

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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
Other	Composite of death/shock, heart failure/new myocardial infarction at 1-year	Composite of death/shock, heart failure/new myocardial infarction at 1-year	1 year
Other	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
Primary	Complete ST-Segment Resolution	ST-segment recovery as assessed by complete ST-segment resolution (>50%)	90 minutes post TNK administration
Secondary	Frequency of rescue/urgent PCI	Frequency of rescue/urgent PCI following the administration of fibrinolysis.	approximately 3-24 hours post TNK administration
Secondary	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	approximately 30 minutes post TNK administration
Secondary	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
Secondary	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.
Secondary	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.
Secondary	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	Day 1 (pre reperfusion), Day 3 +/-2d (hospital discharge), and Day 90 +/-2d after infarction.
Secondary	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.
Secondary	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)