Cooling and dilution during heart attack treatment to protect the heart
Trans-coronary Cooling and Dilution for Cardioprotection During Revascularisation for ST-elevation Myocardial Infarction
This study is testing if cooling and diluting the blood during heart attack treatment can help protect the heart and improve recovery for patients undergoing a specific procedure.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 60 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Royal Brompton & Harefield NHS Foundation Trust Academic / other |
| Locations | 1 site (Uxbridge) |
| Trial ID | NCT06128993 on ClinicalTrials.gov |
What this trial studies
This pilot trial involves 60 patients with ST-Elevation Myocardial Infarction (STEMI) undergoing primary percutaneous coronary intervention (PCI) at Harefield Hospital. The study aims to assess the feasibility and safety of using trans-coronary cooling and dilution during PCI to reduce the size of myocardial infarction. Patients will be randomly assigned to receive either the cooling intervention or standard care, with evaluations of coronary flow, microvascular function, and myocardial salvage through MRI. The study will also analyze blood biomarkers before and after the intervention.
Who should consider this trial
Good fit: Ideal candidates are individuals presenting with ST-elevation myocardial infarction within 12 hours of symptom onset.
Not a fit: Patients with severe asthma, pregnancy, or severe concomitant diseases with a life expectancy of less than one year may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly reduce heart damage during heart attacks, improving patient outcomes.
How similar studies have performed: While similar approaches have been explored, this specific method of trans-coronary cooling and dilution is relatively novel and has not been extensively tested.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Clinical ST-elevation myocardial infarction or equivalent (e.g. new onset LBBB) * \<12 Hrs after symptom onset * Thrombolysis in myocardial infarction (TIMI) 0-1 coronary flow in a target vessel Exclusion Criteria: * History of severe asthma * Pregnancy * Severe concomitant disease or conditions with a life expectancy of less than one year.
Where this trial is running
Uxbridge
- Harefield Hospital — Uxbridge, United Kingdom (Recruiting)
Study contacts
- Principal investigator: Miles C Dalby, MD — Royal Brompton & Harefield NHS Foundation Trust
- Study coordinator: Miles C Dalby, MD
- Email: m.dalby@rbht.nhs.uk
- Phone: +441895 823737
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.