NCT06567249 Intracoronary Hypothermia as a Prevention of Reperfusion Injury in Myocardial Infarction.
| NCT ID | NCT06567249 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Tomsk National Research Medical Center of the Russian Academy of Sciences |
| Condition | Myocardial Infarction |
| Study Type | INTERVENTIONAL |
| Enrollment | 60 participants |
| Start Date | 2024-05-05 |
| Primary Completion | 2026-09 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 60 participants in total. It began in 2024-05-05 with a primary completion date of 2026-09.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility Criteria
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
Contact & Investigator
Christina Nasekina
PRINCIPAL INVESTIGATOR
Cardiology Research Institute, Tomsk National Research Medical Center
Frequently Asked Questions
Who can join the NCT06567249 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 90 Years, studying Myocardial Infarction. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06567249 currently recruiting?
Yes, NCT06567249 is actively recruiting participants. Contact the research team at christina.nasekina@mail.ru for enrollment information.
Where is the NCT06567249 trial being conducted?
This trial is being conducted at Tomsk, Russia.
Who is sponsoring the NCT06567249 clinical trial?
NCT06567249 is sponsored by Tomsk National Research Medical Center of the Russian Academy of Sciences. The principal investigator is Christina Nasekina at Cardiology Research Institute, Tomsk National Research Medical Center. The trial plans to enroll 60 participants.