Melatonin in Patients Under Carotid Endarterectomy

November 5, 2017 updated by: Peking Union Medical College Hospital

The Protective Effect of Melatonin in Patients Under Carotid Endarterectomy

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Trial Title: The protective effect of melatonin in patients under carotid endarterectomy Protocol: Investigators recruited eligible Han Chinese participants (aged 40-80) who were diagnosed with carotid stenosis and had indications for carotid endarterectomy (CEA). Participants were excluded if participants had undergone surgical contraindication, or cardiovascular disease, or cerebral infarction within 3 months, or psychiatric disorders, or cancer, or pregnant, or lactating, or taking antipsychotic drugs during perioperative period. Participants were randomly divided into groups of CEA with oral melatonin, CEA with oral placebo, and CEA with blank control. Participants in groups of CEA with oral melatonin and CEA with oral placebo took melatonin orally 6mg/day or placebo from 3 days before operation to 3 days after operation. Blood samples (about 3 milliliter) were taken at baseline, 6h after the operation and 24h after the operation. Through a series hospital clinical laboratory and related ELISA kits to detect endothelial cell injury and ischemia reperfusion in serum markers. Superoxide dismutase (SOD), malonaldehyde (MDA), S100B protein, endothelial nitric oxide synthase (eNOS), nuclear erythroid 2-related factor 2 (Nrf - 2), Interleukin 6 (IL-6), nuclear transcription factor κB p65 (NF-κB p65) were included for analysis to verify whether melatonin have protective effect in patients under carotid endarterectomy. This trial is approved by the Ethical Committee of Peking Union Medical College Hospital (No ZS 1057). All participants completed a questionnaire and signed an informed consent document. Otherwise, participants will get appropriate economic compensation. To achieve treatment concealment, melatonin and placebo in appearance and package were identically. Trial associates monitored compliance with the masking procedure throughout the trial. All participants and study investigators were unaware of treatment allocation throughout the study. The randomization codes remained sealed until after data collection and cleaning, and completion of a masked analysis. The study team monitored and classified protocol deviations. Investigators summarized baseline clinical and demographic characteristics with descriptive statistics and then determined by the Univariate Analysis of Variance. All the data analyses were done using statistical software SPSS 20.0.

Expected results: Compared with patients under CEA with placebo or blank, patients took melatonin have a lower vascular injury and ischemia reperfusion injury.

Consent document: The potential risk, research as a treatment drug of melatonin may delay the metabolism of antipsychotic antipsychotic drug, so when investigators recruit psychiatric disorders or taking antipsychotic drugs orally during the 2 weeks of the trial should exclusion. As a Health care medicine. Melatonin is not suitable for children, so investigators selected recruiting participants under the age of 40 to 80.

The measure to minimize the risk, fully inform the participants and their families the trial's advantages, disadvantages and desired effect. All participants totally agree with the subjects. In this process, at least three or more effective way to get contact with the medical staff or doctor and ensure that those unexpected accident should deserve effective tackle. Participants guarantee to comply with the criterion before start of the trial. Our research involves the application of melatonin is through the china food and drug administration (CFDA) approved to ensure its safety (include its chemical composition, structure, content parameters, main raw material and appropriate crowd). All staff is qualified medical professionals to guarantee the safety of all participants.

The potential risks or discomfort, or inconvenience, or benefits for participants: So far, effective of melatonin in human include regulating sleep, anti-tumor, immune regulation, regulating of inflammation and immune and regulating blood lipid metabolism is confirmed. Adverse reactions is slow the delay of antipsychotic drug metabolism (so nearly one month ago and during period of the trial participants should not taking antipsychotic drugs) during the trial. The basic principle during the trial is ensure safety of participants.

The relevant content consultation: Everyone have the right to consultation the research content through telephone: +86 01069152500 (principal investigator) and +86 01069155817(Ethics committee).

The rights of withdrew from the trial: Participate in the trial is completely voluntary. If for any reason, participants not willing to participate in, or do not wish to continue to participate in this trial, will not affect the rights and interests of participants. In addition, participants have the right to withdraw this trial at any time. If participants do not according to the doctor instructions, or for the sake of your health and benefits, the doctor or the researchers may also require participants to quit the trial.

The compensation of research: If the participants have any unexpected accident relation with the trial, the compensation and responsibility will be provided by Peking union medical college hospital.

Privacy protection: The privacy of every participant will be protected. The results of the trial in academic publications will not leak any information to identify your personal identity. Peking union medical college hospital will save everybody's data and guarantee not leak without authorization.

Investigators declare no competing interests.

Study Type

Interventional

Enrollment (Actual)

60

Phase

  • Phase 4

Contacts and Locations

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

Study Locations

  • China
    • Beijing
      • Beijing, Beijing, China, 100730
        • Changwei Liu

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

40 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

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

Exclusion Criteria:

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

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: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: CEA with melatonin
Patients under CEA with melatonin taken during perioperative period.
Drug: Melatonin
Patients under CEA taking 6mg/day melatonin orally from 3 days before operation to 3 days after operation.
Placebo Comparator: CEA with placebo
Patients under CEA with placebo taken during perioperative period.
Drug: placebo
Patients under CEA taking placebo orally from 3 days before operation to 3 days after operation.
Sham Comparator: CEA with blank control
Patients under CEA with nothing unnecessary taken during perioperative period.
Other: blank
Patients under CEA without taking melatonin or placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Melatonin effects on patients under CEA assessed by the concentration of SOD
Time Frame: 3 months
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
Time Frame: 3 months
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
Time Frame: 3 months
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
Time Frame: 3 months
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
Time Frame: 3 months
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
Time Frame: 3 months
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
Time Frame: 3 months
Melatonin effects on patients under CEA are detected by the concentration of NF-κB p65 by ELISA kit.
3 months

Collaborators and Investigators

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

Sponsor

Peking Union Medical College Hospital

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)

June 1, 2016

Primary Completion (Actual)

June 1, 2017

Study Completion (Actual)

November 1, 2017

Study Registration Dates

First Submitted

March 22, 2017

First Submitted That Met QC Criteria

April 10, 2017

First Posted (Actual)

April 14, 2017

Study Record Updates

Last Update Posted (Actual)

November 7, 2017

Last Update Submitted That Met QC Criteria

November 5, 2017

Last Verified

March 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • LCW-ZS1057

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

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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