An interventional study of Intracoronary hypothermia and Standard percutaneous coronary intervention in Myocardial Infarction, ST-Elevation Myocardial Infarction (STEMI) and Reperfusion Injury, sponsored by Tomsk National Research Medical Center of the Russian Academy of Sciences. Recruiting at 1 site in Russia. Open to participants aged 18 Years to 90 Years. Per ClinicalTrials.gov, last updated 2025-12-16.
Sponsored by Tomsk National Research Medical Center of the Russian Academy of Sciences · Not applicable, Interventional, and Treatment
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.
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.
850 studies on the registry are indexed under ST Elevation Myocardial Infarction; 197 are open to participants now.
This study's planned enrollment of 60 is below the median of 194 across 527 interventional studies indexed under ST Elevation Myocardial Infarction.
Browse ST Elevation Myocardial Infarction studies →Tomsk National Research Medical Center of the Russian Academy of Sciences is the lead sponsor of 73 studies on the registry; 19 are open to participants now.
Compared within ST Elevation Myocardial Infarction, this study's primary condition as ClinicalTrials.gg classifies it; the registry's first condition term is Myocardial Infarction. The counts are of registry records indexed under each term, refreshed daily. How we classify →
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
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A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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
The group will receive standard percutaneous coronary intervention.
Other: Standard percutaneous coronary intervention
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.
Percutaneous coronary intervention is performed in a standard manner.
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.
Time frame: 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.
Time frame: 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.
Time frame: 7 days
Ejection fraction (percent)
Ejection fraction is measured by echocardiography and expressed as a percentage (Simpson's method).
Time frame: 10 days
Wall motion score index (score)
Wall motion score index (score) measured by echocardiography at day 10.
Time frame: 10 days
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.
Time frame: 1 hour
Major adverse cardiac events (percent)
Incidence of major adverse cardiac events is expressed as a percentage.
Time frame: 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.
Time frame: 5 days
Conduction abnormalities (percent)
Total incidence rate of 2nd and 3rd degree atrioventricular block and sinoatrial block is expressed as a percentage.
Time frame: 5 days
Plan to share: Yes — 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.
Supporting information: Study protocol, Statistical analysis plan, Informed consent form
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.
Access criteria: Information regarding submitting proposals and accessing data may be requested from the principal investigator by e-mail.
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Tomsk National Research Medical Center of the Russian Academy of Sciences