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

December 8, 2025 updated by: Tomsk National Research Medical Center of the Russian Academy of Sciences

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Estimated)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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.
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: Conventional percutaneous coronary intervention
The group will receive standard percutaneous coronary intervention.
Other: Standard percutaneous coronary intervention
Percutaneous coronary intervention is performed in a standard manner.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Infarct size (percent)
Time Frame: 7 days
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)
Time Frame: 7 days
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)
Time Frame: 7 days
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

Outcome Measure
Measure Description
Time Frame
Ejection fraction (percent)
Time Frame: 10 days
Ejection fraction is measured by echocardiography and expressed as a percentage (Simpson's method).
10 days
Wall motion score index (score)
Time Frame: 10 days
Wall motion score index (score) measured by echocardiography at day 10.
10 days

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Thrombolysis in myocardial infarction flow (score)
Time Frame: 1 hour
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)
Time Frame: 30 days
Incidence of major adverse cardiac events is expressed as a percentage.
30 days
Peak value of high-sensitivity troponin T (ng/L)
Time Frame: 5 days
Peak value of high-sensitivity troponin T (ng/L) is measured in blood sample at day 5.
5 days
Conduction abnormalities (percent)
Time Frame: 5 days
Total incidence rate of 2nd and 3rd degree atrioventricular block and sinoatrial block is expressed as a percentage.
5 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Tomsk National Research Medical Center of the Russian Academy of Sciences

Investigators

  • Principal Investigator: Christina Nasekina, Cardiology Research Institute, Tomsk National Research Medical Center
  • Study Director: Vyacheslav Ryabov, Cardiology Research Institute, Tomsk National Research Medical Center
  • Study Chair: Evgenyi Vyshlov, Cardiology Research Institute, Tomsk National Research Medical Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 5, 2024

Primary Completion (Estimated)

September 1, 2026

Study Completion (Estimated)

December 1, 2026

Study Registration Dates

First Submitted

August 18, 2024

First Submitted That Met QC Criteria

August 21, 2024

First Posted (Actual)

August 22, 2024

Study Record Updates

Last Update Posted (Actual)

December 16, 2025

Last Update Submitted That Met QC Criteria

December 8, 2025

Last Verified

September 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CRI-262

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

De-identified individual participant data (text, tables, figures, and appendices), underlying the results of the trial, will be shared with researchers to achieve the aims in the approved proposal.

IPD Sharing Time Frame

Proposals may be submitted up to 36 months following publication of the results of the trial. After 36 months, the data will be available in the Center's data ware house but without investigator support other than deposited metadata.

IPD Sharing Access Criteria

Information regarding submitting proposals and accessing data may be requested from the principal investigator by e-mail.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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