Cardiac Remote Ischemic Preconditioning Prior to Elective Vascular Surgery (CRIPES): A Prospective, Randomized, Sham-Controlled Phase II Clinical Trial

J Am Heart Assoc. 2016 Sep 29;5(10):e003916. doi: 10.1161/JAHA.116.003916.

Abstract

Background: Remote ischemic preconditioning (RIPC) has been shown to reduce infarct size in animal models. We hypothesized that RIPC before an elective vascular operation would reduce the incidence and amount of a postoperative rise of the cardiac troponin level.

Methods and results: Cardiac Remote Ischemic Preconditioning Prior to Elective Vascular Surgery (CRIPES) was a prospective, randomized, sham-controlled phase 2 trial using RIPC before elective vascular procedures. The RIPC protocol consisted of 3 cycles of 5-minute forearm ischemia followed by 5 minutes of reperfusion. The primary endpoint was the proportion of subjects with a detectable increase in cardiac troponin I (cTnI) and the distribution of such increases. From June 2011 to September 2015, 201 male patients (69±7, years) were randomized to either RIPC (n=100) or a sham procedure (n=101). Indications for vascular surgery included an expanding abdominal aortic aneurysm (n=115), occlusive peripheral arterial disease of the lower extremities (n=37), or internal carotid artery stenosis (n=49). Of the 201 patients, 47 (23.5%) had an increase in cTnI above the upper reference limit within 72 hours of the vascular operation, with no statistically significant difference between those patients assigned to RIPC (n=22; 22.2%) versus sham procedure (n=25; 24.7%; P=0.67). Among the cohort with increased cTnI, the median peak values (interquartile range) in the RIPC and control group were 0.048 (0.004-0.174) and 0.017 (0.003-0.105), respectively (P=0.54).

Conclusions: In this randomized, controlled trial of men with increased perioperative cardiac risks, elevation in cardiac troponins was common following vascular surgery, but was not reduced by a strategy of RIPC.

Clinical trial registration: URL: https://www.clinicaltrials.gov. Unique identifier: NCT01558596.

Keywords: remote preconditioning; troponins; vascular surgery.

Publication types

  • Clinical Trial, Phase II
  • Randomized Controlled Trial
  • Research Support, U.S. Gov't, Non-P.H.S.

MeSH terms

  • Aged
  • Aortic Aneurysm, Abdominal / surgery*
  • Arterial Occlusive Diseases / surgery*
  • Carotid Stenosis / surgery*
  • Elective Surgical Procedures
  • Humans
  • Ischemic Preconditioning, Myocardial / methods*
  • Lower Extremity
  • Male
  • Middle Aged
  • Myocardial Ischemia / blood
  • Myocardial Ischemia / prevention & control*
  • Peripheral Arterial Disease / surgery*
  • Postoperative Complications / blood
  • Postoperative Complications / prevention & control*
  • Preoperative Care / methods*
  • Prospective Studies
  • Treatment Outcome
  • Troponin I / blood
  • Vascular Surgical Procedures / methods*

Substances

  • Troponin I

Associated data

  • ClinicalTrials.gov/NCT01558596