Journal of Clinical Trials
Open Access

Abstract

Cardiac Remote Ischemic Preconditioning Prior to Elective Major Vascular Surgery (CRIPES): Study Design and Rationale

Santiago Garcia, Thomas S Rector, Marina Y Zakharova, Amy Magras, Yader Sandoval, Stacy McNabb, Robert Colbert, Steven Santilli and Edward O McFalls

Background: Vascular surgery is considered a high-risk operation with an anticipated perioperative risk of serious cardiac ischemic complications in excess of 10%. One potential strategy for reduction of myocardial ischemia during the perioperative period is Remote Ischemic Preconditioning (RIPC).
Design: The Cardiac Remote Ischemic Preconditioning Prior to Elective Vascular Surgery (CRIPES, NCT:
01558596) is a prospective, randomized, sham-controlled phase 2 trial using RIPC prior to elective vascular surgery. CRIPES plans to enroll and treat 180 patients over 4 years and gather safety and efficacy data for one-month after surgery. Preliminary estimates for two potential measures of efficacy will be examined: 1) a two-part test of postsurgical increases in cardiac troponin I as a measure of myonecrosis and 2) the proportion of patients in each treatment arm meeting the universal definition of myocardial infarction.
Discussion: Knowledge gained from the CRIPES study will help inform further testing of RIPC prior to non-cardiac
surgery.