Remote Ischemic Preconditioning on Brain Injury in Carotid Endarterectomy

NCT ID: NCT03027011

Last Updated: 2017-03-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-03-01

Study Completion Date

2017-12-31

Brief Summary

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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.

Detailed Description

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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

Conditions

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Brain Injuries Remote Ischemic Preconditioning

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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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

Group Type ACTIVE_COMPARATOR

Remote Ischemic Preconditioning

Intervention Type PROCEDURE

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

Control

Control group without remote ischemic preconditioning

Group Type PLACEBO_COMPARATOR

Control

Intervention Type PROCEDURE

Control group without remote ischemic preconditioning

Interventions

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Remote Ischemic Preconditioning

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

Intervention Type PROCEDURE

Control

Control group without remote ischemic preconditioning

Intervention Type PROCEDURE

Other Intervention Names

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RIPC

Eligibility Criteria

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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
Minimum Eligible Age

55 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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The Affiliated Hospital of Xuzhou Medical University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Chen Xiuxia, MD

Role: PRINCIPAL_INVESTIGATOR

The Affiliated Hospital of Xuzhou Medical University

Locations

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The Affiliated Hospital of Xuzhou Medical University

Xuzhou, Jiangsu, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Chen Xiuxia, MD

Role: CONTACT

+86-18052268332

Facility Contacts

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Chen Xiuxia, MD

Role: primary

+86-18052268332

References

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Reference Type RESULT
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Manchurov V, Ryazankina N, Khmara T, Skrypnik D, Reztsov R, Vasilieva E, Shpektor A. Remote ischemic preconditioning and endothelial function in patients with acute myocardial infarction and primary PCI. Am J Med. 2014 Jul;127(7):670-3. doi: 10.1016/j.amjmed.2014.02.012. Epub 2014 Feb 21.

Reference Type RESULT
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Olguner C, Koca U, Kar A, Karci A, Islekel H, Canyilmaz M, Mavioglu O, Kizildag S, Unlu G, Elar Z. Ischemic preconditioning attenuates the lipid peroxidation and remote lung injury in the rat model of unilateral lower limb ischemia reperfusion. Acta Anaesthesiol Scand. 2006 Feb;50(2):150-5. doi: 10.1111/j.1399-6576.2006.00938.x.

Reference Type RESULT
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Xia Z, Herijgers P, Nishida T, Ozaki S, Wouters P, Flameng W. Remote preconditioning lessens the deterioration of pulmonary function after repeated coronary artery occlusion and reperfusion in sheep. Can J Anaesth. 2003 May;50(5):481-8. doi: 10.1007/BF03021061. English, French.

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Jiang HW, Chen C, Hao LJ. [Protective effect of limb ischemic preconditioning against liver ischemia/reperfusion injury in the rat]. Zhongguo Ying Yong Sheng Li Xue Za Zhi. 2010 Nov;26(4):502-4. Chinese.

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Cao L, Yuan G, Wang Y, Chang Y, Xu J, Zou D, Wei L. [Limb ischemic preconditioning reduces rabbit hepatic ischemia-reperfusion injury through inhibition the phosphorylation of proteins in the MAPK signal pathway in the late phase]. Zhong Nan Da Xue Xue Bao Yi Xue Ban. 2012 Jun;37(6):591-7. doi: 10.3969/j.issn.1672-7347.2012.06.009. Chinese.

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Hahn CD, Manlhiot C, Schmidt MR, Nielsen TT, Redington AN. Remote ischemic per-conditioning: a novel therapy for acute stroke? Stroke. 2011 Oct;42(10):2960-2. doi: 10.1161/STROKEAHA.111.622340. Epub 2011 Aug 11.

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Tulu S, Mulino M, Pinggera D, Luger M, Wurtinger P, Grams A, Bodner T, Beer R, Helbok R, Matteucci-Gothe R, Unterhofer C, Gizewski E, Schmutzhard E, Thome C, Ortler M. Remote ischemic preconditioning in the prevention of ischemic brain damage during intracranial aneurysm treatment (RIPAT): study protocol for a randomized controlled trial. Trials. 2015 Dec 29;16:594. doi: 10.1186/s13063-015-1102-6.

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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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Other Identifiers

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XYFY-2017-005

Identifier Type: -

Identifier Source: org_study_id

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