Carotid StenosisPhase 4NCT03115034
Melatonin in Patients Under Carotid Endarterectomy
A Phase 4 study testing Melatonin and blank in people with Carotid Stenosis, run by Peking Union Medical College Hospital at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 40 to 80 years
- Conditions the study is for
- Carotid Stenosis
- What is being tested?
- Melatonin and blank
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteChina
- Study dates
- 1 Jun 2016to 1 Nov 2017
- Phase
- Phase 4
- 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 40 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- diagnosed with carotid stenosis
- had indications for carotid endarterectomy (CEA)
Who cannot join
- surgical contraindication
- cardiovascular disease
- cerebral infarction within 3 months
- psychiatric disorders
- cancer
- pregnant
- lactating
- taking antipsychotic drugs during perioperative period
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Carotid Stenosis
- Being tested
- Melatonin, placebo, blank
- Keywords
- carotid stenosis, melatonin, vascular injury, ischemia reperfusion
- Medical subject headings
- Carotid Stenosis, Vascular System Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MelatoninDrug
Patients under CEA taking 6mg/day melatonin orally from 3 days before operation to 3 days after operation.
placeboDrug
Patients under CEA taking placebo orally from 3 days before operation to 3 days after operation.
blankOther
Patients under CEA without taking melatonin or placebo
| Study group | Role | What they receive |
|---|---|---|
| CEA with melatonin | Active comparator | Patients under CEA with melatonin taken during perioperative period. Receives: Drug: Melatonin |
| CEA with placebo | Placebo comparator | Patients under CEA with placebo taken during perioperative period. Receives: Drug: placebo |
| CEA with blank control | Sham comparator | Patients under CEA with nothing unnecessary taken during perioperative period. Receives: Other: blank |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Apr 2017
- Study start1 Jun 2016
- Primary completion1 Jun 2017
- Study completion1 Nov 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (12)Papers the sponsor has linked to this study.
- Other trials for Carotid StenosisStudies of the same condition, open and under way.
- More trials run by Peking Union Medical College HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Peking Union Medical College Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Changwei Liu, MD, Principal investigator, Peking Union Medical College Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03115034
- Sponsor's protocol ID
- LCW-ZS1057
- Status last verified
- Mar 2017
- First submitted
- 22 Mar 2017
- Last updated
- 7 Nov 2017
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 23725684Lieb 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.
PubMed 22183061Cheng 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.
PubMed 26379832Andersen 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.
PubMed 24318695Wang 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.
PubMed 26681403Walsh 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.
PubMed 20484064Lapi 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.
PubMed 21470301Parsson 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.
PubMed 10727360Weigand 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.
PubMed 9933264Kalra 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.
PubMed 23877801Ge 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.
PubMed 26998048Cervantes 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.
PubMed 18194199
Study at a glance
From the registry record, last updated by the sponsor on 7 Nov 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Protective Effect of Melatonin in Patients Under Carotid Endarterectomy
- ClinicalTrials.gov ID
- NCT03115034
- Acronym / sponsor ID
- LCW-ZS1057
- Conditions
- Carotid Stenosis
- Keywords
- carotid stenosis, melatonin, vascular injury, ischemia reperfusion
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Peking Union Medical College HospitalUniversity, hospital or other
- Study start
- 1 Jun 2016 (actual)
- Primary completion
- 1 Jun 2017 (actual)
- Study completion
- 1 Nov 2017 (actual)
- First posted
- 14 Apr 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| CEA with melatonin | Active comparator | Drug: MelatoninPatients under CEA with melatonin taken during perioperative period. |
| CEA with placebo | Placebo comparator | Drug: placeboPatients under CEA with placebo taken during perioperative period. |
| CEA with blank control | Sham comparator | Other: blankPatients under CEA with nothing unnecessary taken during perioperative period. |
Who may qualify
- Ages
- 40 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- diagnosed with carotid stenosis
- had indications for carotid endarterectomy (CEA)
Key exclusion criteria (8 listed)
- surgical contraindication
- cardiovascular disease
- cerebral infarction within 3 months
- psychiatric disorders
- cancer
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MelatoninPatients under CEA taking 6mg/day melatonin orally from 3 days before operation to 3 days after operation. | Drug | CEA with melatonin |
| placeboPatients under CEA taking placebo orally from 3 days before operation to 3 days after operation. | Drug | CEA with placebo |
| blankPatients under CEA without taking melatonin or placebo | Other | CEA with blank control |
Primary outcome
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.
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.
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.
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.
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.
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.
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Nov 2017.
- Background: PubMed 23725684Kalimeris 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.
- Background: PubMed 22183061Lieb 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.
- Background: PubMed 26379832Cheng 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.
- Background: PubMed 24318695Andersen 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.
- Background: PubMed 26681403Wang 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.
- Background: PubMed 20484064Walsh 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.
- Background: PubMed 21470301Lapi 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.
- Background: PubMed 10727360Parsson 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.
- Background: PubMed 9933264Weigand 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.
- Background: PubMed 23877801Kalra 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.
- Background: PubMed 26998048Ge 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.
- Background: PubMed 18194199Cervantes 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Changwei Liu, MD principal investigator
Peking Union Medical College Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Melatonin and blank in people with Carotid Stenosis, run by Peking Union Medical College Hospital 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 8 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: finished, as of the sponsor's last update on 7 Nov 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Melatonin effects on patients under CEA assessed by the concentration of SOD (time frame: 3 months). The study lists 7 primary outcomes in all. 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 NCT03115034, which also lists 12 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 7 Nov 2017.