alexa Cardiac Remote Ischemic Preconditioning Prior to Electi
ISSN: 2167-0870

Journal of Clinical Trials
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Research Article

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
Tel: 612-467-3670
Fax: 612-727-5668
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.
 

Abstract

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.

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