Feasibility of prehospital delivery of remote ischemic conditioning by emergency medical services in chest pain patients: Protocol for a pilot study

Abstract

Background: Remote ischemic conditioning (RIC) is a non-invasive procedure with hypothesized therapeutic benefits for patients experiencing an acute ST-elevation myocardial infarction (STEMI). Further study of emergency medical services (EMS) delivery of RIC in the prehospital setting is needed to inform the design and methods for future clinical trials of RIC in STEMI patients. The main objective of this pilot study is to assess the feasibility of prehospital delivery of RIC by EMS providers in the United States. Methods: We will conduct a single-arm study of the standard RIC procedure (i.e., up to 4 cycles of alternating 5-min inflation and 5-min deflation of an upper arm cuff) administered by EMS paramedics in 50 patients experiencing acute onset chest pain. The investigational autoRIC® device (CellAegis Devices, Inc., Toronto, Ontario) will be initiated by paramedics during ground ambulance transport. Automated RIC cycles will continue through emergency department arrival and stay. The primary endpoint will be the completion of all 4 cycles of RIC without interruption. We will also examine study procedures and collect qualitative data from study participants and paramedics. Discussion: To our knowledge, this will be the first study in the United States to assess the feasibility of completing the 40-min RIC procedure when initiated during ground ambulance transport. Findings from this pilot study will be used to optimize the design and methods for a future efficacy trial of RIC in acute STEMI patients. Trial registration: NCT03400579 (ClinicalTrials.gov). Registered on 17 January 2018.