Acute myocardial infarction with ST segment elevation is often accompanied by a totally occluded coronary artery. Which has deleterious effects on heart muscle. Primary percutaneous coronary intervention is the most effective mode of treatment for ST-elevation myocardial infarction (STEMI) patients. Despite the restoration of the blood flow, 30-60% of patients develop microvascular obstruction, which lowers the effects of the coronary blood flow restoration. The most advanced coronary microvascular obstruction presents as a no-reflow phenomenon, which is an abrupt deceleration or absence of coronary flow following stent implantation. Several pharmacological treatments have been proposed, as well as deferred stenting, but none of them really helped. Thus, new ways of alleviating coronary obstruction are warranted. One of the new ways of mitigating the reperfusion injury is intracoronary hypothermia, which showed to be safe on a handful of patients in small series. In the animal studies, intracoronary hypothermia demonstrated a protective effect in terms of reducing infarct area. But clinical studies failed to reproduce the protective effects of intracoronary hypothermia. Thus, our study, using a modified hypothermia protocol, will test the hypothermia hypothesis.
Acute ST-elevation myocardial infarction
Time from onset of symptoms less than 12 hours
Given informed consent
Contraindication to MRI
Cardiogenic shock
Conduction disturbance: Atrioventricular block: 2nd and 3rd degree. SA block.
Sick sinus syndrome requiring implantable pacemaker
Parallel
Intracoronary hypothermia
Procedure/SurgeryThis trial stands apart from other studies of intracoronary hypothermia, mainly because it will establish the role of intracoronary hypothermia in reducing infarct size not only in the left anterior descending artery territory but in other vessels as well, including the right coronary artery and circumflex coronary artery.
Standard percutaneous coronary intervention
Other interventionPercutaneous coronary intervention is performed in a standard manner.
Infarct size (percent)
The primary endpoint is the infarct size, expressed as a percentage of total myocardium mass, revealed by the cardiac magnetic resonance imaging with late gadolinium enhancement after seven days.
Myocardial hemorrhage (percent)
Myocardial hemorrhage extent is visualized by T2-weighted sequences on cardiac magnetic resonance imaging and expressed as a percentage of total myocardium mass.
Microvascular obstruction (percent)
Microvascular obstruction is expressed as a percentage of total myocardium mass revealed by the cardiac magnetic resonance imaging with late gadolinium enhancement at day seven.
Ejection fraction (percent)
Ejection fraction is measured by echocardiography and expressed as a percentage (Simpson's method).
Wall motion score index (score)
Wall motion score index (score) measured by echocardiography at day 10.
Thrombolysis in myocardial infarction flow (score)
Thrombolysis in myocardial infarction flow (score) assessed at the end of the primary coronary intervention on the scale from 0 to III.
Major adverse cardiac events (percent)
Incidence of major adverse cardiac events is expressed as a percentage.
Peak value of high-sensitivity troponin T (ng/L)
Peak value of high-sensitivity troponin T (ng/L) is measured in blood sample at day 5.
Conduction abnormalities (percent)
Total incidence rate of 2nd and 3rd degree atrioventricular block and sinoatrial block is expressed as a percentage.
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