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Brain InjuriesNCT03027011

Remote Ischemic Preconditioning on Brain Injury in Carotid Endarterectomy

A study testing Remote Ischemic Preconditioning in people with Brain Injuries and Remote Ischemic Preconditioning, run by The Affiliated Hospital of Xuzhou Medical University at 1 site in China.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

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… Read more about this study

Who is it for?
Ages 55 to 80 years
What is being tested?
Remote Ischemic Preconditioning
Type of treatment
Surgery or procedure
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
40 participants
Where
1 siteChina
Study dates
1 Mar 2017to Dec 2017
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 55 to 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

Chen Xiuxia, MD contact

+86-18052268332

cxxlxy@sina.com

China1 site, 1 recruiting

  • The Affiliated Hospital of Xuzhou Medical University

    Xuzhou, Jiangsu, 221000

    Chen Xiuxia, MD, +86-18052268332, cxxlxy@sina.com

    Recruiting

Other trials in China

About this study

Official title: 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.

Read the 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

Being tested
Remote Ischemic Preconditioning, Control
Medical subject headings
Brain Injuries

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Remote Ischemic PreconditioningProcedure or surgery

    Also called 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

  • ControlProcedure or surgery

    Control group without remote ischemic preconditioning

Study groups in NCT03027011
Study groupRoleWhat they receive
Remote Ischemic Preconditioning(RIPC)Active comparatorRIPC 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
Receives: Procedure: Remote Ischemic Preconditioning
ControlPlacebo comparatorControl group without remote ischemic preconditioning
Receives: Procedure: Control

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. S100-beta biomarker

    tested by ELISA

    Measured: 48 hours post surgery

Secondary outcomes (3)

  1. Short - term cognitive function

    Short - term cognitive function will be tested by mini-mental state examination

    Measured: 1 day before surgery and 1 week post surgery

  2. Neuron specific enolase (NSE) biomarker

    tested by ELISA

    Measured: 48 hours post surgery

  3. Sleep quality

    Sleep quality will be test by medical outcomes study sleep scale

    Measured: 1 week post surgery

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted20 Jan 2017 (estimated)
  2. Study start1 Mar 2017
  3. Primary completionDec 2017 (estimated)
  4. Study completionDec 2017 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Outcomes assessor
Enrolment
40 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03027011
Sponsor's protocol ID
XYFY-2017-005
Status last verified
Mar 2017
First submitted
17 Jan 2017
Last updated
10 Mar 2017
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: IPD will be available when this trial is finished and the article have been published

Publications

  • Naylor AR. What is the current status of angioplasty vs endarterectomy in patients with asymptomatic carotid artery disease? J Cardiovasc Surg (Torino). 2007 Apr;48(2):161-80.

    PubMed 17410063

  • Naylor AR. Where next after SPACE and EVA-3S: 'the good, the bad and the ugly!'. Eur J Vasc Endovasc Surg. 2007 Jan;33(1):44-7. doi: 10.1016/j.ejvs.2006.11.002. Epub 2006 Nov 28.

    PubMed 17126572

  • Brevoord D, Kranke P, Kuijpers M, Weber N, Hollmann M, Preckel B. Remote ischemic conditioning to protect against ischemia-reperfusion injury: a systematic review and meta-analysis. PLoS One. 2012;7(7):e42179. doi: 10.1371/journal.pone.0042179. Epub 2012 Jul 31.

    PubMed 22860077

  • Sanderson TH, Reynolds CA, Kumar R, Przyklenk K, Huttemann M. Molecular mechanisms of ischemia-reperfusion injury in brain: pivotal role of the mitochondrial membrane potential in reactive oxygen species generation. Mol Neurobiol. 2013 Feb;47(1):9-23. doi: 10.1007/s12035-012-8344-z. Epub 2012 Sep 26.

    PubMed 23011809

  • Pundik S, Xu K, Sundararajan S. Reperfusion brain injury: focus on cellular bioenergetics. Neurology. 2012 Sep 25;79(13 Suppl 1):S44-51. doi: 10.1212/WNL.0b013e3182695a14.

    PubMed 23008411

  • Bhuiyan MI, Kim YJ. Mechanisms and prospects of ischemic tolerance induced by cerebral preconditioning. Int Neurourol J. 2010 Dec;14(4):203-12. doi: 10.5213/inj.2010.14.4.203. Epub 2010 Dec 31.

    PubMed 21253330

  • Murry CE, Jennings RB, Reimer KA. Preconditioning with ischemia: a delay of lethal cell injury in ischemic myocardium. Circulation. 1986 Nov;74(5):1124-36. doi: 10.1161/01.cir.74.5.1124.

    PubMed 3769170

  • Przyklenk K, Bauer B, Ovize M, Kloner RA, Whittaker P. Regional ischemic 'preconditioning' protects remote virgin myocardium from subsequent sustained coronary occlusion. Circulation. 1993 Mar;87(3):893-9. doi: 10.1161/01.cir.87.3.893.

    PubMed 7680290

  • Nandagopal K, Dawson TM, Dawson VL. Critical role for nitric oxide signaling in cardiac and neuronal ischemic preconditioning and tolerance. J Pharmacol Exp Ther. 2001 May;297(2):474-8.

    PubMed 11303032

  • Kitagawa K, Matsumoto M, Tagaya M, Hata R, Ueda H, Niinobe M, Handa N, Fukunaga R, Kimura K, Mikoshiba K, et al. 'Ischemic tolerance' phenomenon found in the brain. Brain Res. 1990 Sep 24;528(1):21-4. doi: 10.1016/0006-8993(90)90189-i.

    PubMed 2245337

  • Ederle J, Featherstone RL, Brown MM. Percutaneous transluminal angioplasty and stenting for carotid artery stenosis. Cochrane Database Syst Rev. 2007 Oct 17;(4):CD000515. doi: 10.1002/14651858.CD000515.pub3.

    PubMed 17943745

  • Lim SY, Yellon DM, Hausenloy DJ. The neural and humoral pathways in remote limb ischemic preconditioning. Basic Res Cardiol. 2010 Sep;105(5):651-5. doi: 10.1007/s00395-010-0099-y. Epub 2010 May 7.

    PubMed 20449597

  • 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.

    PubMed 24565591

  • 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.

    PubMed 16430534

  • 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.

    PubMed 12734158

Questions about this trial

What is this clinical trial studying?

A study testing Remote Ischemic Preconditioning in people with Brain Injuries and Remote Ischemic Preconditioning, run by The Affiliated Hospital of Xuzhou Medical University at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 10 Mar 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Chen Xiuxia, MD (+86-18052268332, cxxlxy@sina.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

S100-beta biomarker (time frame: 48 hours post surgery). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03027011, which also lists 26 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Mar 2017.

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