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出境医 / 临床实验 / Melatonin and Coronary Artery Calcification

Melatonin and Coronary Artery Calcification

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

Condition or disease
Coronary Artery Calcification

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 Design
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Study Type : Observational
Actual Enrollment : 574 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Association Between Plasma Melatonin and Coronary Artery Calcification
Actual Study Start Date : May 1, 2017
Actual Primary Completion Date : April 30, 2019
Actual Study Completion Date : April 30, 2019
Arms and Interventions
Group/Cohort
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
Outcome Measures
Primary Outcome Measures :
  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 Outcome Measures :
  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.


Biospecimen Retention:   Samples Without DNA
Blood samples were acquired to evaluate the melatonin, high sensitivity C-reactive protein, malondialdehyde level.

Eligibility Criteria
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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
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.
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.
Contacts and Locations

Locations
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China
PLA general hospital
Beijing, China, 100853
Sponsors and Collaborators
Chinese PLA General Hospital
Investigators
Layout table for investigator information
Principal Investigator: yu jie zhou Beijing Anzhen Hospital
Tracking Information
First Submitted Date May 26, 2019
First Posted Date May 30, 2019
Last Update Posted Date May 30, 2019
Actual Study Start Date May 1, 2017
Actual Primary Completion Date April 30, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: May 28, 2019) 		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.
Original Primary Outcome Measures Same as current
Change History No Changes Posted
Current Secondary Outcome Measures
 (submitted: May 28, 2019)
  • 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.
  • 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.
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Melatonin and Coronary Artery Calcification
Official Title Association Between Plasma Melatonin and Coronary Artery Calcification
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 Type Observational
Study Design Observational Model: Cohort
Time Perspective: Retrospective
Target Follow-Up Duration Not Provided
Biospecimen Retention:   Samples Without DNA
Description:
Blood samples were acquired to evaluate the melatonin, high sensitivity C-reactive protein, malondialdehyde level.
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.
Condition Coronary Artery Calcification
Intervention Not Provided
Study Groups/Cohorts
  • 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
Publications *
  • 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.
  • 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.
  • 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.
  • 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: May 28, 2019) 		574
Original Actual Enrollment Same as current
Actual Study Completion Date April 30, 2019
Actual Primary Completion Date April 30, 2019   (Final data collection date for primary outcome measure)
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.
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years to 80 Years   (Adult, Older Adult)
Accepts Healthy Volunteers Not Provided
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries China
Removed Location Countries  
 
Administrative Information
NCT Number NCT03967366
Other Study ID Numbers MelandCAC
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement
Plan to Share IPD: No
Responsible Party Chen Wei Ren, MD, Chinese PLA General Hospital
Study Sponsor Chinese PLA General Hospital
Collaborators Not Provided
Investigators
Principal Investigator: yu jie zhou Beijing Anzhen Hospital
PRS Account Chinese PLA General Hospital
Verification Date May 2019

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