Melatonin on Coronary Artery Calcification

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

Detailed Description
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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.

Official Title
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Effects of Melatonin on Progression of Coronary Artery Calcification

Conditions
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Coronary Artery Calcification

Intervention / Treatment
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* Drug: Melatonin 3 mg
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Melatonin group<br>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. | Drug: Melatonin 3 mg<br>* Melatonin was taken daily for 6 months.<br>* Other names: melatonin;|
| Placebo Comparator: Control group<br>drug: placebo tablet; the frequency: placebo tablet was taken daily; duration: study treatment was maintained for 6 months. | Drug: Placebo<br>* Placebo tablet was taken daily for 6 months.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| malondialdehyde (MDA) level | a change in malondialdehyde (MDA) level at 6 months after treatment. | at 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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melatonin, coronary artery calcification, adjuvant therapy