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

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.

Conditions

• Myocardial Infarction
• ST-Elevation Myocardial Infarction (STEMI)
• Reperfusion Injury
• Microvascular Occlusion

Interventions

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.

Sponsors & Collaborators

• Tomsk National Research Medical Center of the Russian Academy of Sciences

  lead OTHER

Principal Investigators

• Christina Nasekina · Cardiology Research Institute, Tomsk National Research Medical Center

• Vyacheslav Ryabov · Cardiology Research Institute, Tomsk National Research Medical Center

• Evgenyi Vyshlov · Cardiology Research Institute, Tomsk National Research Medical Center

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

90 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2024-05-05

Primary Completion

2026-09-30

Completion

2026-12-31

Countries

• Russia

Study Locations