Intracoronary Hypothermia as a Prevention of Reperfusion Injury in Myocardial Infarction.
NCT Number: NCT06567249
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Myocardial Infarction|ST-Elevation Myocardial Infarction (STEMI)|Reperfusion Injury|Microvascular Occlusion
Interventions: PROCEDURE: Intracoronary hypothermia|OTHER: Standard percutaneous coronary intervention
Sponsor: Tomsk National Research Medical Center of the Russian Academy of Sciences
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 60
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: SINGLE (PARTICIPANT)|Primary Purpose: TREATMENT
Start Date: 2024-05-05
Completion Date: 2025-12
Locations: Cardiology Research Institute, Tomsk National Research Medical Center, Tomsk, 634012, Russian Federation

Summary:
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.

Primary Outcome Measures: 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., 7 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., 7 days|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., 7 days
Secondary Outcome Measures: Ejection fraction (percent), Ejection fraction is measured by echocardiography and expressed as a percentage (Simpson's method)., 10 days|Wall motion score index (score), Wall motion score index (score) measured by echocardiography at day 10., 10 days
Other Outcome Measures: 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., 1 hour|Major adverse cardiac events (percent), Incidence of major adverse cardiac events is expressed as a percentage., 30 days|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., 5 days|Conduction abnormalities (percent), Total incidence rate of 2nd and 3rd degree atrioventricular block and sinoatrial block is expressed as a percentage., 5 days