Remote Ischemic Preconditioning for Carotid Endarterectomy

NCT02808754 | Completed DMC

• 2 other identifiers: PRO16030479UL1TR001857
• Study Type: interventional
• Target: 86
• Locations: 1 country
• Sites: 1

Brief Summary

This is a randomized controlled trial designed to test an intervention (Remote ischemic preconditioning) in patients undergoing carotid endarterectomy (CEA) for carotid artery stenosis (CAS). The outcomes of interest include neurocognitive function, cardiac complications, and biomarkers of brain ischemia.

Conditions

Carotid Stenosis; Endarterectomy, Carotid

Outcome Measures

Primary Outcomes (2)

• Immediate change in Neurocognitive function

  Montreal cognitive assessment

  1 month before surgery and post operative day 1

• Longterm change in Neurocognitive function

  Montreal cognitive assessment

  1 month before surgery and 1 month post operatively

Secondary Outcomes (6)

• S100-beta biomarker

  Post operative day one

• Troponin

  post operative day one

• Stroke

  within 30 days post operative

• Neuron specific enolase (NSE) biomarker

  Post operative day one

• Adverse cardiac events

  30 days postoperative

Study Arms (2)

Usual Care

NO INTERVENTION

Patients in the usual care arm will undergo CEA without RIPC.

Remote Ischemic Preconditioning

EXPERIMENTAL

Patients in the RIPC arm will undergo CEA with RIPC.

Procedure: Remote Ischemic Preconditioning

Interventions

Remote Ischemic Preconditioning PROCEDURE

Those randomized to RIPC will undergo a standard protocol of 4 cycles of 5 minutes of forearm ischemia with 5 minutes of reperfusion requiring 35 minutes for an application. Forearm ischemia will be induced by a blood pressure cuff inflated to 200mmHg or at least 15mmHg higher than the systolic pressure if systolic \> 185mmHg or until the radial pulse is obliterated. This can occur during anesthesia induction and incision/dissection prior to manipulation or clamping of the carotid.

Remote Ischemic Preconditioning

Eligibility Criteria

• Age: 55 Years - 95 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients undergoing carotid endarterectomy
• Indication for surgery must be symptomatic disease with \>50% stenosis by duplex ultrasound or asymptomatic disease with \>60% stenosis by duplex ultrasound

You may not qualify if:

• Lack of radial pulse on either arm
• Known Deep venous thrombosis (DVT) in arm
• Arteriovenous fistula or graft in both arms
• Diagnosed hypercoagulable state
• Pre-existing lymphedema or axillary node dissection both arms
• Diagnosis of dementia, intellectual disability, or mental illness including depression, anxiety, or schizophrenia
• Simultaneous coronary artery bypass grafting

Sponsors & Collaborators

• University of Pittsburgh: lead

Study Sites (1)

UPMC

Pittsburgh, Pennsylvania, 15213, United States

Location

Related Publications (26)

• Rothwell PM, Eliasziw M, Gutnikov SA, Fox AJ, Taylor DW, Mayberg MR, Warlow CP, Barnett HJ; Carotid Endarterectomy Trialists' Collaboration. Analysis of pooled data from the randomised controlled trials of endarterectomy for symptomatic carotid stenosis. Lancet. 2003 Jan 11;361(9352):107-16. doi: 10.1016/s0140-6736(03)12228-3.

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  PMID: 18783958 BACKGROUND

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  PMID: 25152442 BACKGROUND

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• Walsh SR, Nouraei SA, Tang TY, Sadat U, Carpenter RH, Gaunt ME. Remote ischemic preconditioning for cerebral and cardiac protection during carotid endarterectomy: results from a pilot randomized clinical trial. Vasc Endovascular Surg. 2010 Aug;44(6):434-9. doi: 10.1177/1538574410369709. Epub 2010 May 18.

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• Sahlein DH, Heyer EJ, Rampersad A, Winfree CJ, Solomon RA, Benvenisty AI, Quest DO, Du E, Connolly ES. Failure of intraoperative jugular bulb S-100B and neuron-specific enolase sampling to predict cognitive injury after carotid endarterectomy. Neurosurgery. 2003 Dec;53(6):1243-9 discussion 1249-50. doi: 10.1227/01.neu.0000093493.16850.11.

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MeSH Terms

Conditions

Carotid Stenosis

Condition Hierarchy (Ancestors)

Carotid Artery Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Arterial Occlusive Diseases; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Natalie Sridharan, MD

  University of Pittsburgh

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: June 16, 2016
• First Posted: June 22, 2016
• Study Start: December 1, 2016
• Primary Completion: January 1, 2019
• Study Completion: January 1, 2019
• Last Updated: February 8, 2019

Record last verified: 2019-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)