Effects of Melatonin on Progression of Coronary Artery Calcification
Trial Snapshot
- Phase
- Phase 4
- Sponsor
- Enrollment
- 74
- Locations
- 1
- Primary Endpoint
- a change in CAC score at 6 months measured by coronary CTA
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Single (Investigator)
Eligibility Criteria
- Ages
- 18 Years to 80 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
- •unstable angina pectoris
- •symptomatic chronic heart failure and/or left ventricular ejection fraction (EF) <40%
- •atrial fibrillation or other arrhythmias
- •type I diabetes mellitus or uncontrolled type II diabetes mellitus
- •renal failure
- •liver disease
- •gastrointestinal disease that affected absorption
Arms & Interventions
Melatonin group
drug: melatonin tablets (Sigma-Aldrich Co. LLC, St. Louis, MO, USA); the frequency:3mg melatonin tablet was taken daily; duration: study treatment was maintained for 6 months.
Intervention: Melatonin 3 mg (Drug)
Control group
drug: placebo tablet; the frequency: placebo tablet was taken daily; duration: study treatment was maintained for 6 months.
Intervention: Placebo (Drug)
Outcomes
Primary Outcomes
a change in CAC score at 6 months measured by coronary CTA
Time Frame: at 6 months
The primary efficacy endpoint was the effect of melatonin on the change in CAC score at 6 months compared with placebo.
Secondary Outcomes
- malondialdehyde (MDA) level(at 6 months)
- high-sensitivity C-reactive protein (hsCRP) level(at 6 months)
Investigators
Chen Wei Ren, MD
Prof.
Chinese PLA General Hospital