Melatonin on Coronary Artery Calcification
Schlüsselwörter
Abstrakt
Beschreibung
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.
Termine
| Zuletzt überprüft: | 04/30/2019 |
| Zuerst eingereicht: | 05/25/2019 |
| Geschätzte Einschreibung eingereicht: | 05/27/2019 |
| Zuerst veröffentlicht: | 05/28/2019 |
| Letztes eingereichtes Update: | 05/27/2019 |
| Letztes Update veröffentlicht: | 05/28/2019 |
| Tatsächliches Startdatum der Studie: | 05/31/2019 |
| Geschätztes primäres Abschlussdatum: | 05/31/2021 |
| Voraussichtliches Abschlussdatum der Studie: | 05/31/2021 |
Zustand oder Krankheit
Intervention / Behandlung
Drug: Melatonin group
Drug: Control group
Phase
Armgruppen
| Arm | Intervention / Behandlung |
|---|---|
| Experimental: 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. | Drug: Melatonin group Melatonin was taken daily for 6 months. |
| Placebo Comparator: Control group drug: placebo tablet; the frequency: placebo tablet was taken daily; duration: study treatment was maintained for 6 months. | Drug: Control group Placebo tablet was taken daily for 6 months. |
Zulassungskriterien
| Altersberechtigt für das Studium | 18 Years Zu 18 Years |
| Studienberechtigte Geschlechter | All |
| Akzeptiert gesunde Freiwillige | Ja |
| Kriterien | 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 |
Ergebnis
Primäre Ergebnismaße
1. a change in CAC score at 6 months measured by coronary CTA [at 6 months]
Sekundäre Ergebnismaße
1. high-sensitivity C-reactive protein (hsCRP) level [at 6 months]
2. malondialdehyde (MDA) level [at 6 months]
