Cardiac Remote Ischemic Preconditioning Prior to Elective Major Vascular Surgery (CRIPES): Study Design and Rationale
|Santiago Garcia1*, Thomas S Rector1,2, Marina Y Zakharova1,2, Amy Magras2, Yader Sandoval3, Stacy McNabb2, Robert Colbert2, Steven Santilli1,2 and Edward O McFalls1,2|
|1University of Minnesota Medical School, USA|
|2Minneapolis VA Healthcare System, USA|
|3Hennepin County Medical Center, USA|
|Corresponding Author :||Santiago Garcia, MD
Minneapolis VA Healthcare System
Minneapolis, MN. ZC: 55417, USA
E-mail: [email protected]
|Received April 30, 2013; Accepted June 12, 2013; Published June 14, 2013|
|Citation: Garcia S, Rector TS, Zakharova MY, Magras A, Sandoval Y, et al. (2013) Cardiac Remote Ischemic Preconditioning Prior to Elective Major Vascular Surgery (CRIPES): Study Design and Rationale. J Clin Trials 3:141. doi:10.4172/2167-0870.1000141|
|Copyright: © 2013 2013 Garcia S, et al. This is an open-access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited.|
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