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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

View Article: PubMed Central - PubMed

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.

No MeSH data available.


Distribution of cardiac troponin I according to assigned treatment. RIPC indicates remote ischemic preconditioning.
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jah31756-fig-0003: Distribution of cardiac troponin I according to assigned treatment. RIPC indicates remote ischemic preconditioning.

Mentions: A detectable cTnI increase was present in 22 patients randomized to RIPC and 25 randomized to the sham procedure (22.2% vs 24.7%; P=0.67; Figure 2). The median changes in cTnI were 0.048  (IQR=0.004–0.174) and 0.017 μg/L (IQR=0.003–0.105) in the RIPC and sham groups, respectively (P=0.54; Figure 3). The 2‐part test chi‐square with 2 df was 0.55 (P=0.76). The proportion of patients with detectable cTnI increases was similar among different types of vascular procedures (AAA repair=25%; peripheral bypass=22%; carotid endarterectomy=21%; P=not significant).


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
Distribution of cardiac troponin I according to assigned treatment. RIPC indicates remote ischemic preconditioning.
© Copyright Policy - creativeCommonsBy-nc-nd
Related In: Results  -  Collection

License
Show All Figures
getmorefigures.php?uid=PMC5121495&req=5

jah31756-fig-0003: Distribution of cardiac troponin I according to assigned treatment. RIPC indicates remote ischemic preconditioning.
Mentions: A detectable cTnI increase was present in 22 patients randomized to RIPC and 25 randomized to the sham procedure (22.2% vs 24.7%; P=0.67; Figure 2). The median changes in cTnI were 0.048  (IQR=0.004–0.174) and 0.017 μg/L (IQR=0.003–0.105) in the RIPC and sham groups, respectively (P=0.54; Figure 3). The 2‐part test chi‐square with 2 df was 0.55 (P=0.76). The proportion of patients with detectable cTnI increases was similar among different types of vascular procedures (AAA repair=25%; peripheral bypass=22%; carotid endarterectomy=21%; P=not significant).

View Article: PubMed Central - PubMed

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.

No MeSH data available.