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Completed

NCT Number: NCT03967366

Melatonin and Coronary Artery Calcification

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

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Key information

Conditions

Coronary Artery Calcification

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Observational

Primary location

PLA general hospital

Beijing, 100853, China

About this study

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.

Who can participate

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. correlations of CAC score with melatonin concentrations

    Time frame: Subjects underwent a CAC scan at baseline.

    CAC score was obtained using the coronary CTA and Agatston score.

Secondary outcomes

  1. correlations of CAC score with high-sensitivity C-reactive protein (hsCRP) level

    Time frame: Subjects had blood samples collected at baseline.

    The hsCRP levels were analyzed by a sandwich enzyme linked immunosorbent assay.

  2. correlations of CAC score with malondialdehyde (MDA) level

    Time frame: Subjects had blood samples collected at baseline.

    The MDA levels were analyzed by a sandwich enzyme linked immunosorbent assay.

Sponsors and collaborators

Lead sponsor

Chinese PLA General Hospital

Other

Registry information

Official study title

Association Between Plasma Melatonin and Coronary Artery Calcification

Important dates

Study start
2017
Primary completion
2019
Study completion
2019
First posted
May 30, 2019
Registry last updated
May 30, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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