NCT03967366

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
574

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started May 2017

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2017

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 30, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 30, 2019

Completed
26 days until next milestone

First Submitted

Initial submission to the registry

May 26, 2019

Completed
4 days until next milestone

First Posted

Study publicly available on registry

May 30, 2019

Completed
Last Updated

May 30, 2019

Status Verified

May 1, 2019

Enrollment Period

2 years

First QC Date

May 26, 2019

Last Update Submit

May 28, 2019

Conditions

Coronary Artery Calcification

Keywords

Melatonincoronary artery calcificationrelation

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (2)

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

    Subjects had blood samples collected at baseline.

  • correlations of CAC score with malondialdehyde (MDA) level

    Subjects had blood samples collected at baseline.

Study Arms (4)

plasma melatonin 1

Quartile 1 of plasma melatonin

plasma melatonin 2

Quartile 2 of plasma melatonin

plasma melatonin 3

Quartile 3 of plasma melatonin

plasma melatonin 4

Quartile 4 of plasma melatonin

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability 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.

You may qualify if:

  • Patients with angina-like chest pain, were included in this study. All subjects had blood samples collected and all underwent a coronary CTA scan.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

PLA general hospital

Beijing, 100853, China

Location

Related Publications (4)

  • 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.

    PMID: 26714045BACKGROUND

  • 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.

    PMID: 30402479BACKGROUND

  • 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.

    PMID: 28166668BACKGROUND

  • 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.

    PMID: 26201382BACKGROUND

Biospecimen

Retention: SAMPLES WITHOUT DNA

Blood samples were acquired to evaluate the melatonin, high sensitivity C-reactive protein, malondialdehyde level.

Study Officials

  • yu jie zhou

    Beijing Anzhen Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Prof.

Study Record Dates

First Submitted

May 26, 2019

First Posted

May 30, 2019

Study Start

May 1, 2017

Primary Completion

April 30, 2019

Study Completion

April 30, 2019

Last Updated

May 30, 2019

Record last verified: 2019-05

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)