Impact of intRacoronary adrEnaline on Myocardial reperfuSion in STEMI paTients With Persistent Impaired cORonary Flow After pErcutaneous Coronary Intervention: the RESTORE-SIRIO Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 发起方
- 试验地点
- 2
- 主要终点
- myocardial infarct size (% total LV mass)
研究概览
简要总结
Primary percutaneous coronary intervention (PPCI) is the preferred reperfusion strategy for treating acute ST-segment elevation myocardial infarction (STEMI). The main goals are to restore epicardial infarct-related artery patency and to achieve microvascular reperfusion as early as possible. No-reflow is the term used to describe inadequate myocardial perfusion of a given coronary segment without angiographic evidence of persistent mechanical obstruction of epicardial vessels and it refers to the high resistance of microvascular blood flow encountered during opening of the infarct-related coronary artery.
Despite optimal evidence-based PPCI, myocardial no-reflow can still occur, negating many of the benefits of restoring culprit vessel patency, and is associated with a worse in-hospital and long-term prognosis. Several strategies have been tested to revert the no-reflow including the use of thrombectomy, glycoprotein IIb/IIIa inhibitors and the use of intracoronary adenosine, but none has been demonstrated to effectively counteract the phenomenon.
The trial aims to show the effect of the administration of intracoronary adrenalin on myocardial reperfusion assessed by magnetic resonance in patients with STEMI undergoing PCI and with persistent coronary angiographic The Thrombolysis in Myocardial Infarction (TIMI) 0-1 flow during the interventional procedure after failure of standard therapy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 盲法
- None
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
- •≥18 years of age
- •presentation within 6-7 h of symptom onset of STEMI
- •eligibility for reperfusion by primary-PCI
- •TIMI flow grade 0-1 during the interventional procedure in the culprit vessel after the initial opening of the vessel with the coronary wire
排除标准
- •evident clinical arrhythmias (ventricular tachycardia/ventricular fibrillation)
- •evidence of coronary dissection or spasm
- •Parkinson symptoms
- •closed angle glaucoma
- •thyroid disorders
- •known history to hypersensitivity to the drug
- •pregnancy
- •stage 4 or 5 CKD (eGFR <30 mL/min/1.73 m2)
结局指标
主要结局
myocardial infarct size (% total LV mass)
时间窗: 48-72 hours post intervention
cMRI parameters: myocardial infarct size (% total LV mass)
次要结局
- Incidence and extent of microvascular obstruction(48-72 hours and 30 days post intervention)
- Myocardial salvage index (MSI)(48-72 hours and 30 days post intervention)
- Intra-myocardial haemorrhage (IMH)(48-72 hours and 30 days post intervention)
- LV ejection fraction (LVEF) and volumes(48-72 hours and 30 days post intervention)
- Thrombolysis in Myocardial Infarction (TIMI) flow grade)(48-72 hours post intervention)
- Myocardial blush grade (MBG)(48-72 hours post intervention)
- Computer-assisted myocardial blush quantification using the software 'Quantitative Blush Evaluator' (QuBE)(48-72 hours post intervention)
- Degree of ST segment resolution on ECG(48-72 hours post intervention)
研究者
Klinik für Kardiologie, Pneumologie und Angiologie
Klinik für Kardiologie, Pneumologie und Angiologie
Heinrich-Heine University, Duesseldorf