Using cold saline to prevent heart damage after a heart attack
Selective Intracoronary Hypothermia as a Prevention of Reperfusion Injury in ST-elevation Myocardial Infarction.
This study is testing if using cold saline during heart procedures can help prevent heart damage in people who have just had a heart attack.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 60 (estimated) |
| Ages | 18 Years to 90 Years |
| Sex | All |
| Sponsor | Tomsk National Research Medical Center of the Russian Academy of Sciences Academic / other |
| Drugs / interventions | radiation |
| Locations | 1 site (Tomsk) |
| Trial ID | NCT06567249 on ClinicalTrials.gov |
What this trial studies
This study investigates the use of intracoronary hypothermia as a method to prevent reperfusion injury in patients experiencing ST-elevation myocardial infarction (STEMI). It aims to determine the safety and effectiveness of administering cold saline during percutaneous coronary intervention, a common treatment for restoring blood flow in blocked arteries. Patients will be randomly assigned to receive either the hypothermia treatment or standard revascularization. The study will enroll 60 participants and has received ethical approval.
Who should consider this trial
Good fit: Ideal candidates are individuals experiencing acute ST-elevation myocardial infarction within 12 hours of symptom onset.
Not a fit: Patients with contraindications to MRI, cardiogenic shock, or significant conduction disturbances may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly reduce heart damage and improve recovery outcomes for patients after a heart attack.
How similar studies have performed: While some small series have shown safety in using hypothermia, this approach is still relatively novel and untested on a larger scale.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Tomsk
- Cardiology Research Institute, Tomsk National Research Medical Center — Tomsk, Russia (Recruiting)
Study contacts
- Principal investigator: Christina Nasekina — Cardiology Research Institute, Tomsk National Research Medical Center
- Study coordinator: Christina Nasekina
- Email: christina.nasekina@mail.ru
- Phone: 7-983-239-63-70
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.