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RECRUITING
NCT06567249
NA

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

Sponsor: Tomsk National Research Medical Center of the Russian Academy of Sciences

View on ClinicalTrials.gov

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.

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

Key Details

Gender

All

Age Range

18 Years - 90 Years

Study Type

INTERVENTIONAL

Enrollment

60

Start Date

2024-05-05

Completion Date

2026-12

Last Updated

2025-12-16

Healthy Volunteers

No

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.

Locations (1)

Cardiology Research Institute, Tomsk National Research Medical Center

Tomsk, Russia