Transcutaneous electrical nerve stimulation (TENS) for ischemia-reperfusion injury and secondary prevention post-PCI in STEMI: study protocol for a randomized controlled trial

Abstract Background Effective strategies for managing ischemia-reperfusion injury in acute myocardial infarction remain limited, despite advances in reperfusion therapy. Transcutaneous electrical nerve stimulation (TENS), a safe and non-invasive intervention with good patient compliance, modulates pain perception and autonomic activity via specific neural pathways. These properties make it a promising candidate for integration into secondary prevention following percutaneous coronary intervention (PCI). Therefore, this randomized controlled trial investigates the potential of TENS as an innovative therapeutic approach in patients with ST-segment elevation myocardial infarction (STEMI). Methods This study was a multicenter randomized controlled trial designed to assess the effect of TENS in STEMI patients undergoing reperfusion. Using a randomization of district groups, 200 eligible patients will be randomized to either the treatment group or the control group (1:1 ratio), with all patients receiving standard PCI. The intervention will be administered for 3 days. The primary endpoint is myocardial infarct size (assessed by serial cardiac biomarker measurements), and secondary endpoints include inflammatory markers, myocardial injury markers, left ventricular function, heart rate variability, and major cardiovascular events. All patients will be followed for 12 weeks. Discussion This trial aims to explore TENS as a novel, non-invasive strategy for mitigating reperfusion injury and enhancing secondary prevention in STEMI patients, addressing a critical gap in current post-PCI management. Trial registration www.chictr.org.cn , Registration No. ChiCTR2400082515. Registered on 30 March 2024.