Transcoronary cooling and dilution for cardioprotection during revascularisation for ST-segment elevation myocardial infarction: design and rationale of the STEMI-Cool study.

Abstract

Background: ST-segment elevation myocardial infarction (STEMI) is treated with immediate primary percutaneous coronary intervention (pPCI) to restore coronary blood flow in the acutely ischaemic territory, but is associated with reperfusion injury limiting the benefit of the therapy. No treatment has proven effective in reducing reperfusion injury. Transcoronary hypothermia has been tested in clinical studies and is well tolerated, but is generally established after crossing the occlusion with a guidewire therefore after initial reperfusion, which might have contributed to the neutral outcomes. Transcatheter strategies may also offer additional benefit through haemodilution and the resultant controlled reperfusion, but this has not been fully investigated for pPCI.

Design: STEMI-Cool is a pragmatic, registry-based randomised clinical pilot trial to test the recruitment rate, feasibility, and safety of a simple transcoronary cooling and dilution protocol. Sixty STEMI patients undergoing pPCI will be randomised 1:1 to standard of care or continuous infusion of room temperature saline through the guiding catheter to achieve intracoronary temperature reductions of 6-8°C, commencing before crossing the coronary occlusion with a guidewire. Mechanistic outcome measures will include microvascular resistance, biomarkers of inflammation before infusion and at 24h, and magnetic resonance imaging of myocardial salvage and infarct size.

Conclusions: STEMI-Cool will investigate the recruitment rate, feasibility and safety of an innovative and simple cooling and diluting strategy for cardioprotection before and during reperfusion with pPCI, aiming to address limitations faced in other studies. Mechanistic outcome measures will allow insight into inflammatory, microvascular and structural changes induced by transcoronary cooling and dilution.