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Cardiac Remote Ischemic Preconditioning Prior to Elective Vascular Surgery (CRIPES): A Prospective, Randomized, Sham-Controlled Phase II Clinical Trial.
J Am Heart Assoc. 2016 09 29; 5(10)JA

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.

Authors+Show Affiliations

Division of Cardiology, Department of Internal Medicine, Minneapolis VA Healthcare System, Minneapolis, MN Division of Cardiology, University of Minnesota, Minneapolis, MN garci205@umn.edu.Division of Cardiology, Department of Internal Medicine, Minneapolis VA Healthcare System, Minneapolis, MN.Division of Cardiology, University of Minnesota, Minneapolis, MN.Division of Cardiology, Department of Internal Medicine, Minneapolis VA Healthcare System, Minneapolis, MN.Division of Cardiology, Department of Internal Medicine, Minneapolis VA Healthcare System, Minneapolis, MN Division of Cardiology, University of Minnesota, Minneapolis, MN.Division of Cardiology, Department of Internal Medicine, Minneapolis VA Healthcare System, Minneapolis, MN Division of Cardiology, University of Minnesota, Minneapolis, MN.Hennepin County Medical Center, Minneapolis, MN Minneapolis Heart Institute, Abbott Northwestern Hospital, Minneapolis, MN.Division of Vascular Surgery, Minneapolis VA Healthcare System, Minneapolis, MN.VA North Texas Health Care System and University of Texas Southwestern Medical Center, Dallas, TX.Division of Cardiology, Department of Internal Medicine, Minneapolis VA Healthcare System, Minneapolis, MN Division of Cardiology, University of Minnesota, Minneapolis, MN.

Pub Type(s)

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

Language

eng

PubMed ID

27688236

Citation

Garcia, Santiago, et al. "Cardiac Remote Ischemic Preconditioning Prior to Elective Vascular Surgery (CRIPES): a Prospective, Randomized, Sham-Controlled Phase II Clinical Trial." Journal of the American Heart Association, vol. 5, no. 10, 2016.
Garcia S, Rector TS, Zakharova M, et al. Cardiac Remote Ischemic Preconditioning Prior to Elective Vascular Surgery (CRIPES): A Prospective, Randomized, Sham-Controlled Phase II Clinical Trial. J Am Heart Assoc. 2016;5(10).
Garcia, S., Rector, T. S., Zakharova, M., Herrmann, R. R., Adabag, S., Bertog, S., Sandoval, Y., Santilli, S., Brilakis, E. S., & McFalls, E. O. (2016). Cardiac Remote Ischemic Preconditioning Prior to Elective Vascular Surgery (CRIPES): A Prospective, Randomized, Sham-Controlled Phase II Clinical Trial. Journal of the American Heart Association, 5(10).
Garcia S, et al. Cardiac Remote Ischemic Preconditioning Prior to Elective Vascular Surgery (CRIPES): a Prospective, Randomized, Sham-Controlled Phase II Clinical Trial. J Am Heart Assoc. 2016 09 29;5(10) PubMed PMID: 27688236.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Cardiac Remote Ischemic Preconditioning Prior to Elective Vascular Surgery (CRIPES): A Prospective, Randomized, Sham-Controlled Phase II Clinical Trial. AU - Garcia,Santiago, AU - Rector,Thomas S, AU - Zakharova,Marina, AU - Herrmann,Rebekah R, AU - Adabag,Selcuk, AU - Bertog,Stefan, AU - Sandoval,Yader, AU - Santilli,Steve, AU - Brilakis,Emmanouil S, AU - McFalls,Edward O, Y1 - 2016/09/29/ PY - 2016/11/1/pubmed PY - 2017/12/20/medline PY - 2016/10/1/entrez KW - remote preconditioning KW - troponins KW - vascular surgery JF - Journal of the American Heart Association JO - J Am Heart Assoc VL - 5 IS - 10 N2 - 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. SN - 2047-9980 UR - https://www.unboundmedicine.com/medline/citation/27688236/Cardiac_Remote_Ischemic_Preconditioning_Prior_to_Elective_Vascular_Surgery__CRIPES_:_A_Prospective_Randomized_Sham_Controlled_Phase_II_Clinical_Trial_ L2 - http://www.ahajournals.org/doi/full/10.1161/JAHA.116.003916?url_ver=Z39.88-2003&rfr_id=ori:rid:crossref.org&rfr_dat=cr_pub=pubmed DB - PRIME DP - Unbound Medicine ER -