Acute ST-segment Elevation Myocardial Infarction, No-reflow Phenomen, Percutaneous Coronary Intervention
Conditions
Brief summary
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.
Interventions
OTHERintracoronary epinephrine
after failure of standard therapy patients will treated with epinephrine
OTHERno intracoronary epinephrine
patients will receive standard therapy only
Sponsors
SIRIO MEDICINE
Heinrich-Heine University, Duesseldorf
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* ≥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
Exclusion criteria
* 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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| myocardial infarct size (% total LV mass) | 48-72 hours post intervention | cMRI parameters: myocardial infarct size (% total LV mass) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Incidence and extent of microvascular obstruction | 48-72 hours and 30 days post intervention | cMRI parameter |
| Myocardial salvage index (MSI) | 48-72 hours and 30 days post intervention | cMRI parameter |
| Intra-myocardial haemorrhage (IMH) | 48-72 hours and 30 days post intervention | cMRI parameter |
| LV ejection fraction (LVEF) and volumes | 48-72 hours and 30 days post intervention | cMRI parameter |
| Computer-assisted myocardial blush quantification using the software 'Quantitative Blush Evaluator' (QuBE) | 48-72 hours post intervention | Angiographic markers |
| Degree of ST segment resolution on ECG | 48-72 hours post intervention | — |
| Thrombolysis in Myocardial Infarction (TIMI) flow grade) | 48-72 hours post intervention | Angiographic markers |
| Myocardial blush grade (MBG) | 48-72 hours post intervention | Angiographic markers |
Other
| Measure | Time frame | Description |
|---|---|---|
| creatine kinase and troponin I release | 48-72 hours post intervention | — |
| major cardiovascular events (MACE) | 30 days post intervention | death, need for Target Lesion Revascularization, recurrent myocardial infarction (MI), new or worsening heart failure |
Countries
Germany
Outcome results
None listed