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

NCT ID: NCT06567249

Last Updated: 2025-12-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-05-05

Study Completion Date

2026-12-31

Brief Summary

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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.

Detailed Description

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The study aims to find the most effective methods for the prevention and treatment of microvascular obstruction and reperfusion injury, studying the pathophysiological mechanisms of the development of this complication is of key importance. Many of these mechanisms are now known. In particular, the risk of developing microvascular obstruction is directly proportional to the duration of coronary artery occlusion, the degree of platelet aggregation activity, and blood viscosity and is higher in patients with massive thrombosis of the ischemic artery during percutaneous coronary intervention, which suggests a significant contribution to the development of microembolization during mechanical thrombus fragmentation. Despite all the collected data, there is no effective mode of reperfusion injury prophylaxis. Thus, it is necessary to explore new ways of minimizing reperfusion injury during primary percutaneous coronary intervention. The goal of our study is to determine the safety and effectiveness of intracoronary hypothermia. All patients who meet the eligibility criteria for this study will be randomized in a 1:1 ratio to receive intracoronary hypothermia with subsequent percutaneous coronary intervention or a standard revascularization strategy. The total number of patients planned to be recruited is 60. The study was approved by the local ethics committee. The intracoronary hypothermia group will receive 4°C normal saline with an infusion rate of 5 ml/min for 5 minutes through the inflated over-the-wire balloon, followed by an infusion of 4°C normal saline for 15 minutes with the same infusion rate of 5 ml per minute through the deflated over-the-wire balloon. After that, standard percutaneous coronary intervention is performed. The control group will receive only the standard percutaneous coronary intervention procedure.

Conditions

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

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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Intracoronary hypothermia

Selective intracoronary hypothermia starts by advancing the coronary guidewire beyond the occlusion of the culprit coronary vessel with subsequent over-the-wire balloon inflation at 5 atm at the site of the occlusion. Then, the guidewire is removed, and the infusion pump is connected to the over-the-wire balloon. Normal saline infusion starts with an infusion rate of 5 ml per minute and a duration of 5 minutes. The temperature of the saline is 4 °C. After that, the over-the-wire balloon is deflated, and infusion continues for 15 minutes at the same temperature and infusion rate of 5 mL per minute, followed by the standard percutaneous coronary intervention.

Group Type EXPERIMENTAL

Intracoronary hypothermia

Intervention Type PROCEDURE

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.

Conventional percutaneous coronary intervention

The group will receive standard percutaneous coronary intervention.

Group Type OTHER

Standard percutaneous coronary intervention

Intervention Type OTHER

Percutaneous coronary intervention is performed in a standard manner.

Interventions

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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.

Intervention Type PROCEDURE

Standard percutaneous coronary intervention

Percutaneous coronary intervention is performed in a standard manner.

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Tomsk National Research Medical Center of the Russian Academy of Sciences

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Christina Nasekina

Role: PRINCIPAL_INVESTIGATOR

Cardiology Research Institute, Tomsk National Research Medical Center

Vyacheslav Ryabov

Role: STUDY_DIRECTOR

Cardiology Research Institute, Tomsk National Research Medical Center

Evgenyi Vyshlov

Role: STUDY_CHAIR

Cardiology Research Institute, Tomsk National Research Medical Center

Locations

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Cardiology Research Institute, Tomsk National Research Medical Center

Tomsk, , Russia

Site Status RECRUITING

Countries

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Russia

Central Contacts

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Christina Nasekina

Role: CONTACT

[email protected]
7-983-239-63-70

Yury Bogdanov

Role: CONTACT

[email protected]
7-913-520-77-77

Facility Contacts

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Christina Nasekina

Role: primary

[email protected]
7-983-239-63-70

Yury Bogdanov

Role: backup

[email protected]

Other Identifiers

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CRI-262

Identifier Type: -

Identifier Source: org_study_id