Intracoronary Hypothermia as a Prevention of Reperfusion Injury in Myocardial Infarction.
Recruiting now · Not applicable
Conditions studied: Myocardial Infarction, ST-Elevation Myocardial Infarction (STEMI), Reperfusion Injury, Microvascular Occlusion
In brief
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.
Key facts
- Study ID
- NCT06567249
- Run by
- Tomsk National Research Medical Center of the Russian Academy of Sciences
- People needed
- 60
- Starts
- 2024-05-05
- Expected to finish
- 2026-12-01
- Last updated by the study team
- 2025-12-16
Who can join
Age: 18 and older, up to 90. Sex: any. Healthy volunteers: not accepted.
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
Where it is running
- Cardiology Research Institute, Tomsk National Research Medical Center — Tomsk, Russia (enrolling)
Full record on ClinicalTrials.gov
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