Melatonin and Coronary Artery Calcification

Completed

• Conditions: Coronary Artery Calcification

• Registration Number: NCT03967366
• Lead Sponsor: Chinese PLA General Hospital

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.

Study Timeline

• Study Start: 2017-05-01
• Primary Completion: 2019-04-30
• Study Completion: 2019-04-30
• Status Verified: 2019-05
• Study First Submitted: 2019-05-26
• Study First Submitted QC: 2019-05-28
• Last Update Submitted: 2019-05-28
• Study First Posted: 2019-05-30
• Last Update Posted: 2019-05-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 574

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
correlations of CAC score with melatonin concentrations	Subjects underwent a CAC scan at baseline.	CAC score was obtained using the coronary CTA and Agatston score.

Secondary Outcome Measures

Name	Time	Method
correlations of CAC score with high-sensitivity C-reactive protein (hsCRP) level	Subjects had blood samples collected at baseline.	The hsCRP levels were analyzed by a sandwich enzyme linked immunosorbent assay.
correlations of CAC score with malondialdehyde (MDA) level	Subjects had blood samples collected at baseline.	The MDA levels were analyzed by a sandwich enzyme linked immunosorbent assay.

Trial Locations

Locations (1)

PLA general hospital; 🇨🇳 Beijing, China