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

García, Santiago; Rector, Thomas S.; Zakharova, Marina; Magras, Amy; Yader, S; oval,; McNabb, Stacy; Colbert, Robert; Santilli, Steven M.; McFalls, Edward O.

doi:10.4172/2167-0870.1000141

Cited by 14 publications

(25 citation statements)

References 53 publications

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“…This cardioprotective mechanism is now being translated into clinical practice, with positive results in several clinical trials in coronary artery bypass surgery, surgical repair of abdominal aortic aneurysms, valve replacement surgery and percutaneous coronary intervention [34][35][36][37][38][39][40] .…”

Section: ■ Discussionmentioning

confidence: 99%

Cardioprotective effect of preconditioning is more efficient than postconditioning in rats submitted to cardiac ischemia and reperfusion

et al. 2018

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Cardioprotective effect of preconditioning is more efficient than postconditioning in rats submitted to cardiac ischemia and reperfusion 1 AbstractPurpose: To investigate the cardioprotective effects of ischemic preconditioning (preIC) and postconditioning (postIC) in animal model of cardiac ischemia/reperfusion. Methods: Adult rats were submitted to protocol of cardiac ischemia/reperfusion (I/R) and randomized into three experimental groups: cardiac I/R (n=33), preCI + cardiac I/R (n=7) and postCI + cardiac I/R (n=8). After this I/R protocol, the incidence of ventricular arrhythmia (VA), atrioventricular block (AVB) and lethality (LET) was evaluated using the electrocardiogram (ECG) analysis. Results: After reestablishment of coronary blood flow, we observed variations of the ECG trace with increased incidence of ventricular arrhythmia (VA) (85%), atrioventricular block (AVB) (79%), and increase of lethality (70%) in cardiac I/R group. The comparison between I/R + preIC group with I/R group demonstrated significant reduction in VA incidence to 28%, AVB to 0% and lethality to 14%. The comparison of I/R + postIC group with I/R group was observed significance reduction in AVB incidence to 25% and lethality to 25%. Conclusion:The preconditioning strategies produce cardioprotection more efficient that postconditioning against myocardial dysfunctions and lethality by cardiac ischemia and reperfusion.

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Section: ■ Discussionmentioning

confidence: 99%

Cardioprotective effect of preconditioning is more efficient than postconditioning in rats submitted to cardiac ischemia and reperfusion

et al. 2018

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“…C ardiac R emote I schemic P reconditioning Prior to E lective Vascular S urgery (CRIPES, NCT 01558596) was a prospective, single‐center, randomized, sham‐controlled phase 2 trial of RIPC before elective vascular surgery. Details of the study protocol have been previously published . Consenting subjects were randomized to RIPC or a sham procedure using permutated blocks of 2 or 4 subjects.…”

Section: Methodsmentioning

confidence: 99%

“…All EVAR procedures were performed with surgical cut down. Exclusion criteria included an acute coronary syndrome in the preceding 6 weeks, severe uncorrected valvular heart disease (ie, aortic stenosis with mean gradient ≥40 mm Hg or aortic valve area <1 cm 2 and/or grade 3 or 4 mitral regurgitation), peripheral arterial disease of the upper extremities manifested by a systolic blood pressure difference of ≥20 mm Hg, hemodialysis, pregnancy, and inability or unwillingness to provide informed consent …”

Section: Methodsmentioning

confidence: 99%

“…Based on previous data on the effect of RIPC before coronary angioplasty, we estimated that RIPC will decrease the proportion of subjects with detectable increase in cTnI from 35% to 15% and lower the median of the distribution of detectable increases by ≈60%. The number of subjects needed in each randomly assigned treatment group to have 80% or 90% power to detect these effects was estimated to be 67 and 88, respectively, with a 2‐sided alpha error of 0.05 . Therefore, we planned to enroll 180 to 200 patients over 4 years.…”

Section: Methodsmentioning

confidence: 99%

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C ardiac R emote I schemic P reconditioning Prior to E lective Vascular S urgery (CRIPES): A Prospective, Randomized, Sham‐Controlled Phase II Clinical Trial

García

Rector

Zakharova

et al. 2016

JAHA

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BackgroundRemote 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 ResultsCardiac 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).ConclusionsIn 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.

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“…The Cardiac Remote Ischemic Preconditioning Prior to Elective Vascular Surgery (CRIPES, NCT: 01558596) was designed to determine the feasibility and safety of using remote ischemic preconditioning (RIPC) prior to vascular surgery, and to obtain preliminary estimates of its effects on detectable postsurgical increases in cardiac troponin Ⅰ [42] . A similar strategy of RIPC has been evaluated prior to coronary angioplasty [43] and coronary artery bypass surgery [44] with positive initial results.…”

Section: Future Directionsmentioning

confidence: 99%

Perioperative clinical variables and long-term survival following vascular surgery

García¹

2014

WJC

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Cardiovascular disease is the leading cause of death in patients with peripheral arterial disease (PAD). Coronary artery disease (CAD) is highly prevalent, and often times coexist, in patients with PAD. The management of patients with PAD that requires a high-risk vascular surgical procedure for intermittent claudication, critical limb ischemia or expanding abdominal aortic aneurysm requires risk stratification with the revised cardiac risk index, optimization of medical therapies, and limited use of cardiac imaging prior to surgery. Preventive revascularization in patients with stable CAD, with the sole intention to mitigate the risk of cardiac complications in the peri-operative period, is not effective and may be associated with significant bleeding and thrombotic risks, in particular if stents are used. A strategy of universal use of cardiac troponins in the perioperative period for active surveillance of myocardial ischemia may be more reasonable and cost-effective than the current standard of care of widespread use of cardiac imaging prior to high-risk surgery. An elevated cardiac troponin after vascular surgery is predictive of longterm mortality risk. Medical therapies such as aspirin and statins are recommended for patients with postoperative myocardial ischemia. Ongoing trials are assessing the role of novel anticoagulants. Additional research is needed to define the role of cardiac imaging and invasive angiography in this population.

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

Cited by 14 publications

References 53 publications

Cardioprotective effect of preconditioning is more efficient than postconditioning in rats submitted to cardiac ischemia and reperfusion

Cardioprotective effect of preconditioning is more efficient than postconditioning in rats submitted to cardiac ischemia and reperfusion

C ardiac R emote I schemic P reconditioning Prior to E lective Vascular S urgery (CRIPES): A Prospective, Randomized, Sham‐Controlled Phase II Clinical Trial

Perioperative clinical variables and long-term survival following vascular surgery

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