Melatonin on Coronary Artery Calcification

Coronary Artery Calcification Clinical Trial

— MelonCAC  

Official title:

Effects of Melatonin on Progression of Coronary Artery Calcification

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03966235
• Other study ID #: MelonCAC
• Status: Recruiting
• Phase: Phase 4
• Start date: June 1, 2019
• Est. completion date: June 1, 2021

Study information

• Verified date: May 2019
• Source: Chinese PLA General Hospital
• Contact: wei ren chen, MD
• Phone: +8601066876231
• Email: chen_weiren[@]sina.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

We planned to evaluate the effects of melatonin on progression of coronary artery calcification (CAC) in patients with moderate calcified coronary atherosclerosis.

Description:

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. The investigators planned to determine the efficacy of melatonin on progression of coronary artery calcification (CAC) in patients with moderate calcified coronary atherosclerosis. This study may shed light as to whether oral melatonin supplementation can be an adjunct therapy in CAC patients.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 74
• Est. completion date: June 1, 2021
• Est. primary completion date: June 1, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

Patients with a documented Agatston score=30 and moderate calcified coronary atherosclerosis (<50% diameter lumen narrowing) were eligible for the study.

Exclusion Criteria:

1. unstable angina pectoris

2. symptomatic chronic heart failure and/or left ventricular ejection fraction (EF) <40%

3. atrial fibrillation or other arrhythmias

4. type I diabetes mellitus or uncontrolled type II diabetes mellitus

5. renal failure

6. liver disease

7. gastrointestinal disease that affected absorption

Related Conditions & MeSH terms

• Arteriosclerosis
• Calcinosis
• Coronary Artery Calcification
• Coronary Artery Disease

Intervention

Drug:
• Melatonin 3 mg
Melatonin was taken daily for 6 months.
• Placebo
Placebo tablet was taken daily for 6 months.

Locations

Country	Name	City	State
China	PLA general hospital	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Chinese PLA General Hospital

Country where clinical trial is conducted

China, 

References & Publications (5)

Dehdashtian E, Mehrzadi S, Yousefi B, Hosseinzadeh A, Reiter RJ, Safa M, Ghaznavi H, Naseripour M. Diabetic retinopathy pathogenesis and the ameliorating effects of melatonin; involvement of autophagy, inflammation and oxidative stress. Life Sci. 2018 Jan 15;193:20-33. doi: 10.1016/j.lfs.2017.12.001. Epub 2017 Dec 5. Review. — View Citation

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. — View Citation

Gilham D, Tsujikawa LM, Sarsons CD, Halliday C, Wasiak S, Stotz SC, Jahagirdar R, Sweeney M, Johansson JO, Wong NCW, Kalantar-Zadeh K, Kulikowski E. Apabetalone downregulates factors and pathways associated with vascular calcification. Atherosclerosis. 2019 Jan;280:75-84. doi: 10.1016/j.atherosclerosis.2018.11.002. Epub 2018 Nov 14. — View Citation

Shobeiri N, Bendeck MP. Interleukin-1ß Is a Key Biomarker and Mediator of Inflammatory Vascular Calcification. Arterioscler Thromb Vasc Biol. 2017 Feb;37(2):179-180. doi: 10.1161/ATVBAHA.116.308724. — View Citation

Wang Z, Ni L, Wang J, Lu C, Ren M, Han W, Liu C. The protective effect of melatonin on smoke-induced vascular injury in rats and humans: a randomized controlled trial. J Pineal Res. 2016 Mar;60(2):217-27. doi: 10.1111/jpi.12305. Epub 2016 Jan 13. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	a change in CAC score at 6 months measured by coronary CTA	The primary efficacy endpoint was the effect of melatonin on the change in CAC score at 6 months compared with placebo.	at 6 months
Secondary	high-sensitivity C-reactive protein (hsCRP) level	a change in high-sensitivity C-reactive protein (hsCRP) level at 6 months after treatment.	at 6 months
Secondary	malondialdehyde (MDA) level	a change in malondialdehyde (MDA) level at 6 months after treatment.	at 6 months