Intracoronary Hypothermia as a Prevention of Reperfusion Injury in Myocardial Infarction.
Selective Intracoronary Hypothermia as a Prevention of Reperfusion Injury in ST-elevation Myocardial Infarction.
1 other identifier
interventional
60
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started May 2024
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 5, 2024
CompletedFirst Submitted
Initial submission to the registry
August 18, 2024
CompletedFirst Posted
Study publicly available on registry
August 22, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
December 1, 2026
December 16, 2025
September 1, 2025
2.3 years
August 18, 2024
December 8, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
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.
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.
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.
7 days
Secondary Outcomes (2)
Ejection fraction (percent)
10 days
Wall motion score index (score)
10 days
Other Outcomes (4)
Thrombolysis in myocardial infarction flow (score)
1 hour
Major adverse cardiac events (percent)
30 days
Peak value of high-sensitivity troponin T (ng/L)
5 days
- +1 more other outcomes
Study Arms (2)
Intracoronary hypothermia
EXPERIMENTALSelective 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.
Conventional percutaneous coronary intervention
OTHERThe group will receive standard percutaneous coronary intervention.
Interventions
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.
Eligibility Criteria
You may qualify if:
- Acute ST-elevation myocardial infarction
- Time from onset of symptoms less than 12 hours
- Given informed consent
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Cardiology Research Institute, Tomsk National Research Medical Center
Tomsk, 634012, Russia
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- 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
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 18, 2024
First Posted
August 22, 2024
Study Start
May 5, 2024
Primary Completion (Estimated)
September 1, 2026
Study Completion (Estimated)
December 1, 2026
Last Updated
December 16, 2025
Record last verified: 2025-09
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, ICF
- 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.
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.