Carotid Stenosis Clinical Trial
— RIP-CEAOfficial title:
Remote Ischemic Preconditioning for Carotid Endarterectomy
Verified date | February 2019 |
Source | University of Pittsburgh |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 86 |
Est. completion date | January 2019 |
Est. primary completion date | January 2019 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 55 Years to 95 Years |
Eligibility |
Inclusion Criteria: - 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 Exclusion Criteria: - 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 |
Country | Name | City | State |
---|---|---|---|
United States | UPMC | Pittsburgh | Pennsylvania |
Lead Sponsor | Collaborator |
---|---|
University of Pittsburgh |
United States,
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Hausenloy DJ, Yellon DM. Remote ischaemic preconditioning: underlying mechanisms and clinical application. Cardiovasc Res. 2008 Aug 1;79(3):377-86. doi: 10.1093/cvr/cvn114. Epub 2008 May 2. Review. — View Citation
Healy DA, Clarke Moloney M, McHugh SM, Grace PA, Walsh SR. Remote ischaemic preconditioning as a method for perioperative cardioprotection: concepts, applications and future directions. Int J Surg. 2014 Oct;12(10):1093-9. doi: 10.1016/j.ijsu.2014.08.352. Epub 2014 Aug 21. Review. — View Citation
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Inoue T, Ohwaki K, Tamura A, Tsutsumi K, Saito I, Saito N. Subclinical ischemia verified by somatosensory evoked potential amplitude reduction during carotid endarterectomy: negative effects on cognitive performance. J Neurosurg. 2013 May;118(5):1023-9. doi: 10.3171/2013.1.JNS121668. Epub 2013 Mar 1. — View Citation
Kragsterman B, Pärsson H, Lindbäck J, Bergqvist D, Björck M; Swedish Vascular Registry (Swedvasc). Outcomes of carotid endarterectomy for asymptomatic stenosis in Sweden are improving: Results from a population-based registry. J Vasc Surg. 2006 Jul;44(1):79-85. Epub 2006 May 6. — View Citation
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Le Page S, Bejan-Angoulvant T, Angoulvant D, Prunier F. Remote ischemic conditioning and cardioprotection: a systematic review and meta-analysis of randomized clinical trials. Basic Res Cardiol. 2015 Mar;110(2):11. doi: 10.1007/s00395-015-0467-8. Epub 2015 Feb 5. Review. — View Citation
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Qu L, Feng J, Zou S, Bai J, Hu Z, Guo M, Jing Z. Improved visual, acoustic, and neurocognitive functions after carotid endarterectomy in patients with minor stroke from severe carotid stenosis. J Vasc Surg. 2015 Sep;62(3):635-44.e2. doi: 10.1016/j.jvs.2015.04.401. Epub 2015 Jun 10. — View Citation
Rasmussen LS, Christiansen M, Johnsen J, Grønholdt ML, Moller JT. Subtle brain damage cannot be detected by measuring neuron-specific enolase and S-100beta protein after carotid endarterectomy. J Cardiothorac Vasc Anesth. 2000 Apr;14(2):166-70. — View Citation
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. — View Citation
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. — View Citation
Steiger HJ, Hänggi D. Ischaemic preconditioning of the brain, mechanisms and applications. Acta Neurochir (Wien). 2007 Jan;149(1):1-10. Epub 2006 Dec 14. Review. — View Citation
Vlasov TD, Korzhevskii DE, Polyakova EA. Ischemic preconditioning of the rat brain as a method of endothelial protection from ischemic/repercussion injury. Neurosci Behav Physiol. 2005 Jul;35(6):567-72. — View Citation
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. — View Citation
Walsh SR, Tang TY, Kullar P, Jenkins DP, Dutka DP, Gaunt ME. Ischaemic preconditioning during cardiac surgery: systematic review and meta-analysis of perioperative outcomes in randomised clinical trials. Eur J Cardiothorac Surg. 2008 Nov;34(5):985-94. doi: 10.1016/j.ejcts.2008.07.062. Epub 2008 Sep 9. Review. — View Citation
Wang Q, Zhou M, Zhou Y, Ji J, Raithel D, Qiao T. Effects of Carotid Endarterectomy on Cerebral Reperfusion and Cognitive Function in Patients with High Grade Carotid Stenosis: A Perfusion Weighted Magnetic Resonance Imaging Study. Eur J Vasc Endovasc Surg. 2015 Jul;50(1):5-12. doi: 10.1016/j.ejvs.2015.03.032. Epub 2015 Apr 29. — View Citation
Wilson DA, Mocco J, D'Ambrosio AL, Komotar RJ, Zurica J, Kellner CP, Hahn DK, Connolly ES, Liu X, Imielinska C, Heyer EJ. Post-carotid endarterectomy neurocognitive decline is associated with cerebral blood flow asymmetry on post-operative magnetic resonance perfusion brain scans. Neurol Res. 2008 Apr;30(3):302-6. Epub 2007 Sep 4. — View Citation
* Note: There are 26 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Immediate change in Neurocognitive function | Montreal cognitive assessment | 1 month before surgery and post operative day 1 | |
Primary | Longterm change in Neurocognitive function | Montreal cognitive assessment | 1 month before surgery and 1 month post operatively | |
Secondary | S100-beta biomarker | serum level of S100-beta | Post operative day one | |
Secondary | Troponin | serum troponin level | post operative day one | |
Secondary | Stroke | Stroke diagnosed by MRI findings of new stroke (obtained if symptomatic) | within 30 days post operative | |
Secondary | Neuron specific enolase (NSE) biomarker | Serum level of NSE | Post operative day one | |
Secondary | Adverse cardiac events | Any new myocardial infarction, new arrhythmia, or new onset heart failure | 30 days postoperative | |
Secondary | Severity of stroke | National Institute of Health Stroke Scale | 30 days postoperative |
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