Clinical trial NCT03966235: Melatonin on Coronary Artery Calcification
Official title: Effects of Melatonin on Progression of Coronary Artery Calcification
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Coronary Artery Calcification
Keywords: melatonin
coronary artery calcification
adjuvant therapy
Lead sponsor: Chinese PLA General Hospital
Sponsor class: OTHER
First posted: 2019-05-29
Enrollment: 74
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: a change in CAC score at 6 months measured by coronary CTA
timeFrame: at 6 months
Secondary outcomes:
measure: high-sensitivity C-reactive protein (hsCRP) level
timeFrame: at 6 months
measure: malondialdehyde (MDA) level
timeFrame: at 6 months
Other outcomes:
Locations:
city: Beijing
country: China
facility: PLA general hospital
Study officials:
affiliation: Beijing Anzhen Hospital
name: yu jie zhou
role: PRINCIPAL_INVESTIGATOR
References:
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citation: Shobeiri N, Bendeck MP. Interleukin-1beta 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. No abstract available.
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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.