Melatonin in Patients Under Carotid Endarterectomy

NCT03115034 | Completed Phase 4 DMC

• 1 other identifier: LCW-ZS1057
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

The main purpose of this study is to evaluate the effects of melatonin in the regulation of the vascular injury in patients under carotid endarterectomy through population-based, randomized, double-blind, placebo-controlled trial.

Conditions

Carotid Stenosis

Keywords

carotid stenosis; melatonin; vascular injury; ischemia reperfusion

Outcome Measures

Primary Outcomes (7)

• Melatonin effects on patients under CEA assessed by the concentration of SOD

  Melatonin effects on patients under CEA are detected by the concentration of SOD by ELISA kit.

  3 months

• Melatonin effects on patients under CEA assessed by the concentration of MDA

  Melatonin effects on patients under CEA are detected by the concentration of MDA by ELISA kit.

  3 months

• Melatonin effects on patients under CEA assessed by the concentration of S100b

  Melatonin effects on patients under CEA are detected by the concentration of S100b by ELISA kit.

  3 months

• Melatonin effects on patients under CEA assessed by the concentration of eNOS

  Melatonin effects on patients under CEA are detected by the concentration of eNOS by ELISA kit.

  3 months

• Melatonin effects on patients under CEA assessed by the concentration of Nrf-2

  Melatonin effects on patients under CEA are detected by the concentration of Nrf-2 by ELISA kit.

  3 months

• Melatonin effects on patients under CEA assessed by the concentration of IL-6

  Melatonin effects on patients under CEA are detected by the concentration of IL-6 by ELISA kit.

  3 months

• Melatonin effects on patients under CEA assessed by the concentration of NF-κB p65

  Melatonin effects on patients under CEA are detected by the concentration of NF-κB p65 by ELISA kit.

  3 months

Study Arms (3)

CEA with melatonin

ACTIVE COMPARATOR

Patients under CEA with melatonin taken during perioperative period.

Drug: Melatonin

CEA with placebo

PLACEBO COMPARATOR

Patients under CEA with placebo taken during perioperative period.

Drug: placebo

CEA with blank control

SHAM COMPARATOR

Patients under CEA with nothing unnecessary taken during perioperative period.

Other: blank

Interventions

Melatonin DRUG

Patients under CEA taking 6mg/day melatonin orally from 3 days before operation to 3 days after operation.

CEA with melatonin

placebo DRUG

Patients under CEA taking placebo orally from 3 days before operation to 3 days after operation.

CEA with placebo

blank OTHER

Patients under CEA without taking melatonin or placebo

CEA with blank control

Eligibility Criteria

• Age: 40 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• diagnosed with carotid stenosis
• had indications for carotid endarterectomy (CEA)

You may not qualify if:

• surgical contraindication
• cardiovascular disease
• cerebral infarction within 3 months
• psychiatric disorders
• cancer
• pregnant
• lactating
• taking antipsychotic drugs during perioperative period

Sponsors & Collaborators

• Peking Union Medical College Hospital: lead

Study Sites (1)

Changwei Liu

Beijing, Beijing Municipality, 100730, China

Location

Related Publications (12)

• Kalimeris K, Kouni S, Kostopanagiotou G, Nomikos T, Fragopoulou E, Kakisis J, Vasdekis S, Matsota P, Pandazi A. Cognitive function and oxidative stress after carotid endarterectomy: comparison of propofol to sevoflurane anesthesia. J Cardiothorac Vasc Anesth. 2013 Dec;27(6):1246-52. doi: 10.1053/j.jvca.2012.12.009. Epub 2013 May 30.

  PMID: 23725684 BACKGROUND

• Lieb M, Shah U, Hines GL. Cerebral hyperperfusion syndrome after carotid intervention: a review. Cardiol Rev. 2012 Mar-Apr;20(2):84-9. doi: 10.1097/CRD.0b013e318237eef8.

  PMID: 22183061 BACKGROUND

• Cheng L, Jin Z, Zhao R, Ren K, Deng C, Yu S. Resveratrol attenuates inflammation and oxidative stress induced by myocardial ischemia-reperfusion injury: role of Nrf2/ARE pathway. Int J Clin Exp Med. 2015 Jul 15;8(7):10420-8. eCollection 2015.

  PMID: 26379832 BACKGROUND

• Andersen LP, Rosenberg J, Gogenur I. Perioperative melatonin: not ready for prime time. Br J Anaesth. 2014 Jan;112(1):7-8. doi: 10.1093/bja/aet332. No abstract available.

  PMID: 24318695 BACKGROUND

• Wang Z, Ni L, Wang J, Lu C, Ren M, Han W, Liu C. The protective effect of melatonin on smoke-induced vascular injury in rats and humans: a randomized controlled trial. J Pineal Res. 2016 Mar;60(2):217-27. doi: 10.1111/jpi.12305. Epub 2016 Jan 13.

  PMID: 26681403 BACKGROUND

• 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.

  PMID: 20484064 BACKGROUND

• Lapi D, Vagnani S, Cardaci E, Paterni M, Colantuoni A. Rat pial microvascular responses to melatonin during bilateral common carotid artery occlusion and reperfusion. J Pineal Res. 2011 Aug;51(1):136-44. doi: 10.1111/j.1600-079X.2011.00870.x. Epub 2011 Apr 7.

  PMID: 21470301 BACKGROUND

• Parsson HN, Lord RS, Scott K, Zemack G. Maintaining carotid flow by shunting during carotid endarterectomy diminishes the inflammatory response mediating ischaemic brain injury. Eur J Vasc Endovasc Surg. 2000 Feb;19(2):124-30. doi: 10.1053/ejvs.1999.0954.

  PMID: 10727360 BACKGROUND

• Weigand MA, Laipple A, Plaschke K, Eckstein HH, Martin E, Bardenheuer HJ. Concentration changes of malondialdehyde across the cerebral vascular bed and shedding of L-selectin during carotid endarterectomy. Stroke. 1999 Feb;30(2):306-11. doi: 10.1161/01.str.30.2.306.

  PMID: 9933264 BACKGROUND

• Kalra VB, Rao B, Malhotra A. Teaching NeuroImages: perfusion imaging of cerebral hyperperfusion syndrome following revascularization. Neurology. 2013 Jul 23;81(4):e25-6. doi: 10.1212/WNL.0b013e31829c5cae.

  PMID: 23877801 BACKGROUND

• Ge YL, Li X, Gao JU, Zhang X, Fang X, Zhou L, Ji W, Lin S. Beneficial effects of intravenous dexmedetomidine on cognitive function and cerebral injury following a carotid endarterectomy. Exp Ther Med. 2016 Mar;11(3):1128-1134. doi: 10.3892/etm.2016.2978. Epub 2016 Jan 11.

  PMID: 26998048 BACKGROUND

• Cervantes M, Morali G, Letechipia-Vallejo G. Melatonin and ischemia-reperfusion injury of the brain. J Pineal Res. 2008 Aug;45(1):1-7. doi: 10.1111/j.1600-079X.2007.00551.x. Epub 2008 Jan 9.

  PMID: 18194199 BACKGROUND

MeSH Terms

Conditions

Carotid Stenosis; Vascular System Injuries

Interventions

Melatonin

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Tryptamines; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists

Study Officials

• Changwei Liu, MD

  Peking Union Medical College Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 22, 2017
• First Posted: April 14, 2017
• Study Start: June 1, 2016
• Primary Completion: June 1, 2017
• Study Completion: November 1, 2017
• Last Updated: November 7, 2017

Record last verified: 2017-03

Locations

CN (1)