Cardiac Remote Ischemic Preconditioning Prior to Elective Vascular Surgery (CRIPES): A Prospective, Randomized, Sham-Controlled Phase II Clinical Trial.
J Am Heart Assoc
; 5(10)2016 09 29.
Article
en En
| MEDLINE
| ID: mdl-27688236
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 ANDRESULTS:
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.Palabras clave
Texto completo:
1
Colección:
01-internacional
Base de datos:
MEDLINE
Asunto principal:
Complicaciones Posoperatorias
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Arteriopatías Oclusivas
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Procedimientos Quirúrgicos Vasculares
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Cuidados Preoperatorios
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Estenosis Carotídea
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Isquemia Miocárdica
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Aneurisma de la Aorta Abdominal
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Precondicionamiento Isquémico Miocárdico
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Enfermedad Arterial Periférica
Tipo de estudio:
Clinical_trials
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Guideline
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Observational_studies
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Risk_factors_studies
Límite:
Aged
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Humans
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Male
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Middle aged
Idioma:
En
Revista:
J Am Heart Assoc
Año:
2016
Tipo del documento:
Article
País de afiliación:
Mongolia