Clinical trial NCT04217304: SONOthrombolysis in Patients With an ST-segment Elevation Myocardial Infarction With fibrinoLYSIS (SONOSTEMI-LYSIS) Trial
Official title: SONOthrombolysis in Patients With an ST-segment Elevation Myocardial Infarction With fibrinoLYSIS (SONOSTEMI-LYSIS) Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
Conditions: ST Elevation Myocardial Infarction
Lead sponsor: University of Alberta
Sponsor class: OTHER
Collaborators: name: Canadian VIGOUR Centre
First posted: 2020-01-03
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility 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

Primary outcomes:
measure: Complete ST-Segment Resolution
timeFrame: 90 minutes post TNK administration
Secondary outcomes:
measure: Frequency of rescue/urgent PCI
timeFrame: approximately 3-24 hours post TNK administration
measure: ST-segment resolution (>50%)
timeFrame: approximately 30 minutes post TNK administration
measure: ST-segment resolution (continuous)
timeFrame: approximately 30 minutes post TNK administration
measure: Left ventricular ejection fraction
timeFrame: Day 1 (pre reperfusion), Day 3 +/-2d (hospital discharge), and Day 90 +/-2d after infarction.
measure: Wall motion score index (WMSI)
timeFrame: Day 1 (pre reperfusion), Day 3 +/-2d (hospital discharge), and Day 90 +/-2d after infarction.
measure: Microvascular perfusion score index (MPSI)
timeFrame: Day 1 (pre reperfusion), Day 3 +/-2d (hospital discharge), and Day 90 +/-2d after infarction.
measure: Global Longitudinal Strain (GLS)
timeFrame: Day 1 (pre reperfusion), Day 3 +/-2d (hospital discharge), and Day 90 +/-2d after infarction.
measure: QRS Score
timeFrame: Day 3 +/-2d (hospital discharge)
Other outcomes:
measure: Composite of death/shock, heart failure/new myocardial infarction in hospital
timeFrame: Until hospital discharge, approximately 5 days
measure: Composite of death/shock, heart failure/new myocardial infarction at 1-year
timeFrame: 1 year
measure: TIMI flow grade pre and post PCI on index angiogram
timeFrame: pre and post PCI on index angiogram, approximately 3-24 hours post TNK administration
Locations:
city: Edmonton
country: Canada
facility: University of Alberta
state: Alberta
Study officials:
References: