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

Phase 2RecruitingNCT04217304

University of Alberta60 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

Conditions

ST Elevation Myocardial Infarction

Interventions

Definity® with High Mechanical Index UltrasoundDRUG

Sonothrombolysis; Echocardiographic imaging with intermittent diagnostic high mechanical index during an intravenous 5% Definity® infusion

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

University of Alberta

Edmonton, Alberta, Canada

RECRUITING

Outcomes

Primary Outcomes

Complete ST-Segment Resolution

ST-segment recovery as assessed by complete ST-segment resolution (\>50%)

Time frame: 90 minutes post TNK administration

Secondary Outcomes

Frequency of rescue/urgent PCI

Frequency of rescue/urgent PCI following the administration of fibrinolysis.

Time frame: 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

Time frame: 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

Time frame: 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.

Time frame: 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

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.