SONOthrombolysis in Patients With an ST-segment Elevation Myocardial Infarction With fibrinoLYSIS (SONOSTEMI-LYSIS) Trial
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 41
- 试验地点
- 1
- 主要终点
- Complete ST-Segment Resolution
研究概览
简要总结
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
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •1. Isolated inferior STEMI without anterior ST-segment depression
- •Previous coronary bypass surgery
- •Cardiogenic shock
- •Known or suspected hypersensitivity to ultrasound contrast agent used for the study
- •Life expectancy of less than two months or terminally ill
- •Known bleeding diathesis or contraindication to glycoprotein 2b/3a inhibitors, anticoagulants, or aspirin
- •Known large right to left intracardiac shunts
- •Patient received another investigational medication or treatment within 30 days prior to presentation with STEMI
研究组 & 干预措施
Sonothrombolysis
Diagnostic myocardial contrast echocardiography with ultrasound contrast agent 5% Definity® plus Sonothrombolysis
干预措施: Definity® with High Mechanical Index Ultrasound (Drug)
Standard of Care
Diagnostic myocardial contrast echocardiography with ultrasound contrast agent 5% Definity®
结局指标
主要结局
Complete ST-Segment Resolution
时间窗: 90 minutes post TNK administration
ST-segment recovery as assessed by complete ST-segment resolution (\>50%)
次要结局
- Left ventricular ejection fraction(Day 1 (pre reperfusion), Day 3 +/-2d (hospital discharge), and Day 90 +/-2d after infarction.)
- Global Longitudinal Strain (GLS)(Day 1 (pre reperfusion), Day 3 +/-2d (hospital discharge), and Day 90 +/-2d after infarction.)
- Frequency of rescue/urgent PCI(approximately 3-24 hours post TNK administration)
- ST-segment resolution (>50%)(approximately 30 minutes post TNK administration)
- ST-segment resolution (continuous)(approximately 30 minutes post TNK administration)
- Wall motion score index (WMSI)(Day 1 (pre reperfusion), Day 3 +/-2d (hospital discharge), and Day 90 +/-2d after infarction.)
- QRS Score(Day 3 +/-2d (hospital discharge))
- Microvascular perfusion score index (MPSI)(Day 1 (pre reperfusion), Day 3 +/-2d (hospital discharge), and Day 90 +/-2d after infarction.)