- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03967366
Melatonin and Coronary Artery Calcification
May 28, 2019 updated by: Chen Wei Ren, MD, Chinese PLA General Hospital
Association Between Plasma Melatonin and Coronary Artery Calcification
The investigators planned to research the association between plasma melatonin and coronary artery calcification in a Chinese population.
Study Overview
Status
Completed
Conditions
Detailed Description
Coronary artery calcification (CAC) is prevalent in coronary artery disease (CHD), and the extent of CAC predicts cardiovascular risk.
The causes of CAC include dysregulated matrix metabolism, epitaxial mineral deposition, inflammation, oxidative stress, and apoptosis.
Melatonin is the main indoleamine produced by the pineal gland; it is known recently to have anti-inflammatory, anti-cancer and antioxidant activities.
Several studies have shown that melatonin protects against inflammation and apoptosis in vascular calcification.
Melatonin also inhibits oxidative stress-induced apoptosis and calcification in endplate chondrocytes.
However, no study has evaluated whether melatonin is associated with CAC in patients with coronary atherosclerosis.
The investigators planned to research the association between plasma melatonin and coronary artery calcification.
Study Type
Observational
Enrollment (Actual)
574
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
-
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Beijing, China, 100853
- PLA General Hospital
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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
18 years to 80 years (Adult, Older Adult)
Accepts Healthy Volunteers
N/A
Genders Eligible for Study
All
Sampling Method
Probability Sample
Study Population
PLA general hospital (PLAGH) is a large national tertiary-care center in the Beijing, China.
The investigators enrolled patients consecutively in PLAGH.
Description
Inclusion Criteria:
Patients with angina-like chest pain, were included in this study. All subjects had blood samples collected and all underwent a coronary CTA scan.
Exclusion Criteria:
- melatonin treatment
- coronary revascularization (percutaneous coronary intervention or coronary artery bypass graft surgery)
- heart failure or cardiomyopathies
- hepatic failure
- renal dysfunction
- haemolytic disorders
- thyroid disease
- neoplastic diseases
- acute infectious or inflammatory conditions.
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
Cohorts and Interventions
Group / Cohort |
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plasma melatonin 1
Quartile 1 of plasma melatonin
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plasma melatonin 2
Quartile 2 of plasma melatonin
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plasma melatonin 3
Quartile 3 of plasma melatonin
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plasma melatonin 4
Quartile 4 of plasma melatonin
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
correlations of CAC score with melatonin concentrations
Time Frame: Subjects underwent a CAC scan at baseline.
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CAC score was obtained using the coronary CTA and Agatston score.
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Subjects underwent a CAC scan at baseline.
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
correlations of CAC score with high-sensitivity C-reactive protein (hsCRP) level
Time Frame: Subjects had blood samples collected at baseline.
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The hsCRP levels were analyzed by a sandwich enzyme linked immunosorbent assay.
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Subjects had blood samples collected at baseline.
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correlations of CAC score with malondialdehyde (MDA) level
Time Frame: Subjects had blood samples collected at baseline.
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The MDA levels were analyzed by a sandwich enzyme linked immunosorbent assay.
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Subjects had blood samples collected at baseline.
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: yu jie zhou, Beijing Anzhen 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
- Fernandez A, Ordonez R, Reiter RJ, Gonzalez-Gallego J, Mauriz JL. Melatonin and endoplasmic reticulum stress: relation to autophagy and apoptosis. J Pineal Res. 2015 Oct;59(3):292-307. doi: 10.1111/jpi.12264. Epub 2015 Aug 9.
- Olson F, Engborg J, Gronhoj MH, Sand NP, Lambrechtsen J, Steffensen FH, Nybo M, Gerke O, Mickley H, Diederichsen AC. Association between high-sensitive troponin I and coronary artery calcification in a Danish general population. Atherosclerosis. 2016 Feb;245:88-93. doi: 10.1016/j.atherosclerosis.2015.12.017. Epub 2015 Dec 15.
- Kim HJ, Kim JH, Joo MC. Association of Exercise Capacity, Cardiac Function, and Coronary Artery Calcification with Components for Metabolic Syndrome. Biomed Res Int. 2018 Oct 4;2018:4619867. doi: 10.1155/2018/4619867. eCollection 2018.
- Zhao X, Zhang HW, Li S, Zhang Y, Xu RX, Zhu CG, Wu NQ, Guo YL, Qing P, Li XL, Liu G, Dong Q, Sun J, Li JJ. Association between plasma proprotein convertase subtisilin/kexin type 9 concentration and coronary artery calcification. Ann Clin Biochem. 2018 Jan;55(1):158-164. doi: 10.1177/0004563217695351. Epub 2017 May 15.
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)
May 1, 2017
Primary Completion (Actual)
April 30, 2019
Study Completion (Actual)
April 30, 2019
Study Registration Dates
First Submitted
May 26, 2019
First Submitted That Met QC Criteria
May 28, 2019
First Posted (Actual)
May 30, 2019
Study Record Updates
Last Update Posted (Actual)
May 30, 2019
Last Update Submitted That Met QC Criteria
May 28, 2019
Last Verified
May 1, 2019
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- MelandCAC
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
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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