Actively Recruiting
Intracoronary Hypothermia as a Prevention of Reperfusion Injury in Myocardial Infarction.
Led by Tomsk National Research Medical Center of the Russian Academy of Sciences · Updated on 2025-12-16
60
Participants Needed
1
Research Sites
134 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Intracoronary Hypothermia as a Prevention of Reperfusion Injury in Myocardial Infarction.
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Acute ST-elevation myocardial infarction
- Time from onset of symptoms less than 12 hours
- Given informed consent
You will not qualify if you...
- 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
AI-Screening
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Trial Site Locations
Total: 1 location
1
Cardiology Research Institute, Tomsk National Research Medical Center
Tomsk, Russia, 634012
Actively Recruiting
Research Team
C
Christina Nasekina
CONTACT
Y
Yury Bogdanov
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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