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NCT Number: NCT06567249

Intracoronary Hypothermia as a Prevention of Reperfusion Injury in 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.

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Key information

Conditions

Myocardial Infarction Body Temperature Changes Cardiovascular Diseases Heart Diseases Hypothermia Infarction Ischemia Microvascular Occlusion Myocardial Ischemia Necrosis Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications Reperfusion Injury ST Elevation Myocardial Infarction ST-elevation Myocardial Infarction (STEMI) Signs and Symptoms Vascular Diseases

Age range

18 year–90 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Intracoronary hypothermia

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.

Standard percutaneous coronary intervention

Other

Percutaneous coronary intervention is performed in a standard manner.

Primary outcomes

  1. 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.

  2. 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.

  3. 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.

Secondary outcomes

  1. Ejection fraction (percent)

    Time frame: 10 days

    Ejection fraction is measured by echocardiography and expressed as a percentage (Simpson's method).

  2. Wall motion score index (score)

    Time frame: 10 days

    Wall motion score index (score) measured by echocardiography at day 10.

Other outcomes

  1. 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.

  2. Major adverse cardiac events (percent)

    Time frame: 30 days

    Incidence of major adverse cardiac events is expressed as a percentage.

  3. 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.

  4. 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Christina Nasekina

CONTACT

[email protected]

7-983-239-63-70

Yury Bogdanov

CONTACT

[email protected]

7-913-520-77-77

Sponsors and collaborators

Lead sponsor

Tomsk National Research Medical Center of the Russian Academy of Sciences

Other

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Aug 22, 2024
Registry last updated
Dec 16, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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