Melatonin and Coronary Artery Calcification

Coronary Artery Calcification Clinical Trial

Official title:

Association Between Plasma Melatonin and Coronary Artery Calcification

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03967366
• Other study ID #: MelandCAC
• Status: Completed
• Start date: May 1, 2017
• Est. completion date: April 30, 2019

Study information

• Verified date: May 2019
• Source: Chinese PLA General Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 574
• Est. completion date: April 30, 2019
• Est. primary completion date: April 30, 2019
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Arteriosclerosis
• Calcinosis
• Coronary Artery Calcification
• Coronary Artery Disease

Locations

Country	Name	City	State
China	PLA general hospital	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Chinese PLA General Hospital

Country where clinical trial is conducted

China, 

References & Publications (4)

Fernández A, Ordóñez R, Reiter RJ, González-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. Review. — View 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. — View Citation

Olson F, Engborg J, Grønhøj 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	correlations of CAC score with melatonin concentrations	CAC score was obtained using the coronary CTA and Agatston score.	Subjects underwent a CAC scan at baseline.
Secondary	correlations of CAC score with high-sensitivity C-reactive protein (hsCRP) level	The hsCRP levels were analyzed by a sandwich enzyme linked immunosorbent assay.	Subjects had blood samples collected at baseline.
Secondary	correlations of CAC score with malondialdehyde (MDA) level	The MDA levels were analyzed by a sandwich enzyme linked immunosorbent assay.	Subjects had blood samples collected at baseline.