Coronary Artery CalcificationNCT03967366
Melatonin and Coronary Artery Calcification
An observational study of Coronary Artery Calcification, run by Chinese PLA General Hospital at 1 site in China.
Trial summary
The investigators planned to research the association between plasma melatonin and coronary artery calcification in a Chinese population. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Coronary Artery Calcification
- How many people
- 574 participants
- Where
- 1 siteChina
- Study dates
- 1 May 2017to 30 Apr 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- Adult, Older adult
Study population: PLA general hospital (PLAGH) is a large national tertiary-care center in the Beijing, China. The investigators enrolled patients consecutively in PLAGH.
Who may be able to join
- Patients with angina-like chest pain, were included in this study. All subjects had blood samples collected and all underwent a coronary CTA scan.
Who cannot join
- melatonin treatment
- coronary revascularization (percutaneous coronary intervention or coronary artery bypass graft surgery)
- heart failure or cardiomyopathies
- hepatic failure
- renal dysfunction
- haemolytic disorders
Show all 9Show fewer
- thyroid disease
- neoplastic diseases
- acute infectious or inflammatory conditions.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Association Between Plasma Melatonin and Coronary Artery Calcification
The investigators planned to research the association between plasma melatonin and coronary artery calcification in a Chinese population.
Read the 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.
- Conditions
- Coronary Artery Calcification
- Keywords
- Melatonin, coronary artery calcification, relation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
correlations of CAC score with melatonin concentrations
CAC score was obtained using the coronary CTA and Agatston score.
Measured: Subjects underwent a CAC scan at baseline.
Secondary outcomes (2)
correlations of CAC score with high-sensitivity C-reactive protein (hsCRP) level
The hsCRP levels were analyzed by a sandwich enzyme linked immunosorbent assay.
Measured: Subjects had blood samples collected at baseline.
correlations of CAC score with malondialdehyde (MDA) level
The MDA levels were analyzed by a sandwich enzyme linked immunosorbent assay.
Measured: Subjects had blood samples collected at baseline.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 May 2019
- Study start1 May 2017
- Primary completion30 Apr 2019
- Study completion30 Apr 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Coronary Artery CalcificationStudies of the same condition, open and under way.
- More trials run by Chinese PLA General HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 574 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chinese PLA General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Chen Wei Ren, MD, Chinese PLA General Hospital
- Investigators
- yu jie zhou, Principal investigator, Beijing Anzhen Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03967366
- Sponsor's protocol ID
- MelandCAC
- Status last verified
- May 2019
- First submitted
- 26 May 2019
- Last updated
- 30 May 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 26714045Kim 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.
PubMed 30402479Zhao 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.
PubMed 28166668Fernandez 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.
PubMed 26201382
Study at a glance
From the registry record, last updated by the sponsor on 30 May 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Association Between Plasma Melatonin and Coronary Artery Calcification
- ClinicalTrials.gov ID
- NCT03967366
- Acronym / sponsor ID
- MelandCAC
- Conditions
- Coronary Artery Calcification
- Keywords
- Melatonin, coronary artery calcification, relation
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 574 participants (actual)
- Lead sponsor
- Chinese PLA General HospitalUniversity, hospital or other
- Study start
- 1 May 2017 (actual)
- Primary completion
- 30 Apr 2019 (actual)
- Study completion
- 30 Apr 2019 (actual)
- First posted
- 30 May 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- PLA general hospital (PLAGH) is a large national tertiary-care center in the Beijing, China. The investigators enrolled patients consecutively in PLAGH.
Key inclusion criteria (1 listed)
- Patients with angina-like chest pain, were included in this study. All subjects had blood samples collected and all underwent a coronary CTA scan.
Key exclusion criteria (9 listed)
- melatonin treatment
- coronary revascularization (percutaneous coronary intervention or coronary artery bypass graft surgery)
- heart failure or cardiomyopathies
- hepatic failure
- renal dysfunction
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
2 secondary outcomes
correlations of CAC score with high-sensitivity C-reactive protein (hsCRP) level
Time frame: Subjects had blood samples collected at baseline.
correlations of CAC score with malondialdehyde (MDA) level
Time frame: Subjects had blood samples collected at baseline.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 May 2019.
- Background: PubMed 26714045Olson 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.
- Background: PubMed 30402479Kim 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.
- Background: PubMed 28166668Zhao 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.
- Background: PubMed 26201382Fernandez 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
yu jie zhou principal investigator
Beijing Anzhen Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Coronary Artery Calcification, run by Chinese PLA General Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 May 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
correlations of CAC score with melatonin concentrations (time frame: Subjects underwent a CAC scan at baseline.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03967366, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 May 2019.