Clinical trial NCT03967366: Melatonin and Coronary Artery Calcification
Official title: Association Between Plasma Melatonin and Coronary Artery Calcification
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Coronary Artery Calcification
Keywords: Melatonin
coronary artery calcification
relation
Lead sponsor: Chinese PLA General Hospital
Sponsor class: OTHER
First posted: 2019-05-30
Enrollment: 574
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: RETROSPECTIVE
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.

Brief summary: The investigators planned to research the association between plasma melatonin and coronary artery calcification in a Chinese population.

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.

Eligibility criteria: 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:

1. melatonin treatment
2. coronary revascularization (percutaneous coronary intervention or coronary artery bypass graft surgery)
3. heart failure or cardiomyopathies
4. hepatic failure
5. renal dysfunction
6. haemolytic disorders
7. thyroid disease
8. neoplastic diseases
9. acute infectious or inflammatory conditions.

Primary outcomes:
measure: correlations of CAC score with melatonin concentrations
timeFrame: Subjects underwent a CAC scan at baseline.
Secondary outcomes:
measure: correlations of CAC score with high-sensitivity C-reactive protein (hsCRP) level
timeFrame: Subjects had blood samples collected at baseline.
measure: correlations of CAC score with malondialdehyde (MDA) level
timeFrame: Subjects had blood samples collected at baseline.
Other outcomes:
Locations:
city: Beijing
country: China
facility: PLA general hospital
Study officials:
affiliation: Beijing Anzhen Hospital
name: yu jie zhou
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.