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RECRUITINGINTERVENTIONAL

Intracoronary Hypothermia as a Prevention of Reperfusion Injury in Myocardial Infarction.

Selective Intracoronary Hypothermia as a Prevention of Reperfusion Injury in ST-elevation Myocardial Infarction.

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

About This Trial

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.

Who May Be Eligible (Plain English)

Who May Qualify: - Acute ST-elevation myocardial infarction - Time from onset of symptoms less than 12 hours - Given willing to sign a consent form Who Should NOT Join This Trial: - Contraindication to MRI - Cardiogenic shock - Conduction disturbance: Atrioventricular block: 2nd and 3rd degree. SA block. - Sick sinus syndrome requiring implantable pacemaker - Pulmonary edema - Active inflammatory condition - Active chemo/radiation therapy Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language
Inclusion Criteria: * Acute ST-elevation myocardial infarction * Time from onset of symptoms less than 12 hours * Given informed consent Exclusion Criteria: * Contraindication to MRI * Cardiogenic shock * Conduction disturbance: Atrioventricular block: 2nd and 3rd degree. SA block. * Sick sinus syndrome requiring implantable pacemaker * Pulmonary edema * Active inflammatory condition * Active chemo/radiation therapy

Treatments Being Tested

PROCEDURE

Intracoronary hypothermia

This 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.

OTHER

Standard percutaneous coronary intervention

Percutaneous coronary intervention is performed in a standard manner.

Locations (1)

Cardiology Research Institute, Tomsk National Research Medical Center
Tomsk, Russia