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Rationale and Design for the Remote Ischemic Preconditioning for Carotid Endarterectomy Trial.

Abstract

BACKGROUND

While the perioperative stroke rate after carotid endarterectomy (CEA) is low, "silent" microinfarctions identified by magnetic resonance imaging (MRI) are common and have been correlated with postoperative neurocognitive decline. Our study will investigate the role of remote ischemic preconditioning (RIPC) as a potential neuroprotective mechanism. RIPC is a well-tolerated stimulus that, through neuronal and humoral pathways, generates a systemic environment of greater resistance to subsequent ischemic insults. We hypothesized that patients undergoing RIPC before CEA will have improved postoperative neurocognitive scores compared with those of patients undergoing standard care.

METHODS

Patients undergoing CEA will be randomized 1:1 to RIPC or standard clinical care. Those randomized to RIPC will undergo a standard protocol of 4 cycles of RIPC. Each RIPC cycle will involve 5 min of forearm ischemia with 5 min of reperfusion. Forearm ischemia will be induced by a blood pressure cuff inflated to 200 mm Hg or at least 15 mm Hg higher than the systolic pressure if it is >185 mm Hg. This will occur after anesthesia induction and during incision/dissection but before manipulation or clamping of the carotid; thus, patients will be blinded to their assignment. Before carotid endarterectomy, all patients will undergo baseline neurocognitive testing in the form of a Montreal Cognitive Assessment (MoCA) and National Institutes of Health (NIH) Toolbox. MoCA testing only will be conducted on postoperative day 1 in the hospital. The full neurocognitive testing battery will again be conducted at 1-month follow-up in the office. Changes from baseline will be compared between arms at the follow-up time points. Assuming no drop-ins or dropouts and a 10% loss to follow-up, we would need a sample size of 43 patients for 80% power per treatment arm. The primary endpoint, change in MoCA scores, will be analyzed using a random effects model, and secondary outcomes will be analyzed using either linear or logistic regression where appropriate.

CONCLUSIONS

RIPC, if shown to be effective in protecting patients from neurocognitive decline after CEA, represents a safe, inexpensive, and easily implementable method of neuroprotection.

Links

  • Publisher Full Text
  • Authors+Show Affiliations

    ,

    UPMC, Division of Vascular Surgery, Pittsburgh, PA. Electronic address: domenickna2@upmc.edu.

    ,

    UPMC, Division of Vascular Surgery, Pittsburgh, PA.

    ,

    UPMC, Division of Vascular Surgery, Pittsburgh, PA.

    ,

    UPMC, Division of Vascular Surgery, Pittsburgh, PA.

    ,

    UPMC, Division of Vascular Surgery, Pittsburgh, PA.

    ,

    UPMC, Division of Vascular Surgery, Pittsburgh, PA.

    UPMC, Division of Vascular Surgery, Pittsburgh, PA.

    Source

    Annals of vascular surgery : 2019 Jun 12 pg

    Pub Type(s)

    Journal Article

    Language

    eng

    PubMed ID

    31200043

    Citation

    Sridharan, Natalie D., et al. "Rationale and Design for the Remote Ischemic Preconditioning for Carotid Endarterectomy Trial." Annals of Vascular Surgery, 2019.
    Sridharan ND, Robinson D, Thirumala P, et al. Rationale and Design for the Remote Ischemic Preconditioning for Carotid Endarterectomy Trial. Ann Vasc Surg. 2019.
    Sridharan, N. D., Robinson, D., Thirumala, P., Arak, A., Olafiranye, O., Tzeng, E., & Avgerinos, E. (2019). Rationale and Design for the Remote Ischemic Preconditioning for Carotid Endarterectomy Trial. Annals of Vascular Surgery, doi:10.1016/j.avsg.2019.03.014.
    Sridharan ND, et al. Rationale and Design for the Remote Ischemic Preconditioning for Carotid Endarterectomy Trial. Ann Vasc Surg. 2019 Jun 12; PubMed PMID: 31200043.
    * Article titles in AMA citation format should be in sentence-case
    TY - JOUR T1 - Rationale and Design for the Remote Ischemic Preconditioning for Carotid Endarterectomy Trial. AU - Sridharan,Natalie D, AU - Robinson,Darve, AU - Thirumala,Partha, AU - Arak,Ali, AU - Olafiranye,Oladipupo, AU - Tzeng,Edith, AU - Avgerinos,Efthymios, Y1 - 2019/06/12/ PY - 2018/11/19/received PY - 2019/02/18/revised PY - 2019/03/11/accepted PY - 2019/6/15/pubmed PY - 2019/6/15/medline PY - 2019/6/15/entrez JF - Annals of vascular surgery JO - Ann Vasc Surg N2 - BACKGROUND: While the perioperative stroke rate after carotid endarterectomy (CEA) is low, "silent" microinfarctions identified by magnetic resonance imaging (MRI) are common and have been correlated with postoperative neurocognitive decline. Our study will investigate the role of remote ischemic preconditioning (RIPC) as a potential neuroprotective mechanism. RIPC is a well-tolerated stimulus that, through neuronal and humoral pathways, generates a systemic environment of greater resistance to subsequent ischemic insults. We hypothesized that patients undergoing RIPC before CEA will have improved postoperative neurocognitive scores compared with those of patients undergoing standard care. METHODS: Patients undergoing CEA will be randomized 1:1 to RIPC or standard clinical care. Those randomized to RIPC will undergo a standard protocol of 4 cycles of RIPC. Each RIPC cycle will involve 5 min of forearm ischemia with 5 min of reperfusion. Forearm ischemia will be induced by a blood pressure cuff inflated to 200 mm Hg or at least 15 mm Hg higher than the systolic pressure if it is >185 mm Hg. This will occur after anesthesia induction and during incision/dissection but before manipulation or clamping of the carotid; thus, patients will be blinded to their assignment. Before carotid endarterectomy, all patients will undergo baseline neurocognitive testing in the form of a Montreal Cognitive Assessment (MoCA) and National Institutes of Health (NIH) Toolbox. MoCA testing only will be conducted on postoperative day 1 in the hospital. The full neurocognitive testing battery will again be conducted at 1-month follow-up in the office. Changes from baseline will be compared between arms at the follow-up time points. Assuming no drop-ins or dropouts and a 10% loss to follow-up, we would need a sample size of 43 patients for 80% power per treatment arm. The primary endpoint, change in MoCA scores, will be analyzed using a random effects model, and secondary outcomes will be analyzed using either linear or logistic regression where appropriate. CONCLUSIONS: RIPC, if shown to be effective in protecting patients from neurocognitive decline after CEA, represents a safe, inexpensive, and easily implementable method of neuroprotection. SN - 1615-5947 UR - https://www.unboundmedicine.com/medline/citation/31200043/Rationale_and_Design_for_the_Remote_Ischemic_Preconditioning_for_Carotid_Endarterectomy_(RIP-CEA)_Trial L2 - https://linkinghub.elsevier.com/retrieve/pii/S0890-5096(19)30368-1 DB - PRIME DP - Unbound Medicine ER -