Remote Ischemic Preconditioning on Brain Injury in Carotid Endarterectomy

Effect of Remote Ischemic Preconditioning on Brain Injury in Carotid Endarterectomy

This is a randomized controlled trial designed to test an intervention (Remote ischemic preconditioning) in patients undergoing carotid endarterectomy (CEA).Remote ischemic preconditioning(RIPC) with transient upper limb ischemia/reperfusion is a novel, simple, cost-free,non-pharmacological and non-invasive strategy.The purpose of this study is to evaluate the effects of Remote Ischaemic Preconditioning on perioperative ischaemic injury in patients undergoing carotid endarterectomy compared to control intervention.The outcomes of interest include neurocognitive function,clinical outcomes,and biomarkers of brain injury.

Study Overview

Detailed Description

Remote ischemic preconditioning (RIPC) protocol will be induced during anesthesia by 3 cycles of 5-min upper limb ischemia and 5-min reperfusion using a blood pressure cuff inflated to a pressure 200mmHg

Study Type

Interventional

Enrollment (Anticipated)

40

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Chen Xiuxia, MD
  • Phone Number: +86-18052268332
  • Email: cxxlxy@sina.com

Study Locations

    • Jiangsu
      • Xuzhou, Jiangsu, China, 221000
        • Recruiting
        • The Affiliated Hospital of Xuzhou Medical University
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

55 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Patients undergoing carotid endarterectomy
  • Patients aged 55 years to 80 years

Exclusion Criteria:

  • Inability to give informed consent
  • Known Deep venous thrombosis (DVT) in arm
  • Pre-existing lymphedema or axillary node dissection both arms
  • Arteriovenous fistula or graft in both arms
  • Left ventricular ejection fraction less than 50%
  • Diagnosis of dementia, intellectual disability, or mental illness including depression, anxiety, or schizophrenia

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Control
Control group without remote ischemic preconditioning
Control group without remote ischemic preconditioning
Active Comparator: Remote Ischemic Preconditioning(RIPC)
RIPC will be induced during anesthesia by 3 cycles of 5-min upper limb ischemia and 5-min reperfusion using a blood-pressure cuff inflated to a pressure 200mmHg
RIPC will be induced during anesthesia by 3 cycles of 5-min upper limb ischemia and 5-min reperfusion using a blood-pressure cuff inflated to a pressure 200mmHg
Other Names:
  • RIPC

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
S100-beta biomarker
Time Frame: 48 hours post surgery
tested by ELISA
48 hours post surgery

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Short - term cognitive function
Time Frame: 1 day before surgery and 1 week post surgery
Short - term cognitive function will be tested by mini-mental state examination
1 day before surgery and 1 week post surgery
Neuron specific enolase (NSE) biomarker
Time Frame: 48 hours post surgery
tested by ELISA
48 hours post surgery
Sleep quality
Time Frame: 1 week post surgery
Sleep quality will be test by medical outcomes study sleep scale
1 week post surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Chen Xiuxia, MD, The Affiliated Hospital of Xuzhou Medical University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 1, 2017

Primary Completion (Anticipated)

December 1, 2017

Study Completion (Anticipated)

December 1, 2017

Study Registration Dates

First Submitted

January 17, 2017

First Submitted That Met QC Criteria

January 18, 2017

First Posted (Estimate)

January 20, 2017

Study Record Updates

Last Update Posted (Actual)

March 10, 2017

Last Update Submitted That Met QC Criteria

March 9, 2017

Last Verified

March 1, 2017

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

IPD will be available when this trial is finished and the article have been published

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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