NCT06567249Recruiting
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.
Source: ClinicalTrials.gov · Last updated 16 Dec 2025
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 60 (estimated)
- First submitted
- 18 Aug 2024
- Start date
- 5 May 2024
- Primary completion date
- 30 Sept 2026
- Lead sponsor
- Tomsk National Research Medical Center of the Russian Academy of Sciences
- Diseases
- Coronary artery disease
- NCT number
- NCT06567249
What you commit to
- Study type: Interventional
- Planned participants: 60
- From 5 May 2024 to the primary completion date, 30 Sept 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Active chemo/radiation therapy
Other illness
- Sick sinus syndrome requiring implantable pacemaker
- Active inflammatory condition
Other
- Contraindication to MRI
- Cardiogenic shock
- Conduction disturbance: Atrioventricular block: 2nd and 3rd degree. SA block.
- Pulmonary edema
Who the study is looking for
- Acute ST-elevation myocardial infarction
- Time from onset of symptoms less than 12 hours
- Given informed consent
Age in the registry: 18 years to 90 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Cardiology Research Institute, Tomsk National Research Medical Center Coordinator of this site? Confirm its status | Tomsk | Russia | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.