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出境医 / 临床实验 / Melatonin on Coronary Artery Calcification (MelonCAC)

Melatonin on Coronary Artery Calcification (MelonCAC)

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

Condition or disease Intervention/treatment Phase
Coronary Artery Calcification Drug: Melatonin 3 mg Drug: Placebo Phase 4

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
Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 74 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Primary Purpose: Treatment
Official Title: Effects of Melatonin on Progression of Coronary Artery Calcification
Estimated Study Start Date : June 1, 2019
Estimated Primary Completion Date : June 1, 2021
Estimated Study Completion Date : June 1, 2021
Arms and Interventions
Arm Intervention/treatment
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 3 mg
Melatonin was taken daily for 6 months.
Other Name: melatonin
Placebo Comparator: Control group
drug: placebo tablet; the frequency: placebo tablet was taken daily; duration: study treatment was maintained for 6 months.
 Drug: Placebo
Placebo tablet was taken daily for 6 months.
Outcome Measures
Primary Outcome Measures :
  1. 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 Outcome Measures :
  1. high-sensitivity C-reactive protein (hsCRP) level [ Time Frame: at 6 months ]
    a change in high-sensitivity C-reactive protein (hsCRP) level at 6 months after treatment.

  2. malondialdehyde (MDA) level [ Time Frame: at 6 months ]
    a change in malondialdehyde (MDA) level at 6 months after treatment.


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations

Contacts
Layout table for location contacts
Contact: wei ren chen, MD +8601066876231 chen_weiren@sina.com

Locations
Layout table for location information
China
PLA general hospital Recruiting
Beijing, China, 100853
Contact: wei ren chen         
Sponsors and Collaborators
Chinese PLA General Hospital
Investigators
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Principal Investigator: yu jie zhou Beijing Anzhen Hospital
Tracking Information
First Submitted Date  ICMJE May 26, 2019
First Posted Date  ICMJE May 29, 2019
Last Update Posted Date May 29, 2019
Estimated Study Start Date  ICMJE June 1, 2019
Estimated Primary Completion Date June 1, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 28, 2019) 		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.
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: May 28, 2019)
  • high-sensitivity C-reactive protein (hsCRP) level [ Time Frame: at 6 months ]
    a change in high-sensitivity C-reactive protein (hsCRP) level at 6 months after treatment.
  • malondialdehyde (MDA) level [ Time Frame: at 6 months ]
    a change in malondialdehyde (MDA) level at 6 months after treatment.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Melatonin on Coronary Artery Calcification
Official Title  ICMJE Effects of Melatonin on Progression of Coronary Artery Calcification
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 Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Primary Purpose: Treatment
Condition  ICMJE Coronary Artery Calcification
Intervention  ICMJE
  • Drug: Melatonin 3 mg
    Melatonin was taken daily for 6 months.
    Other Name: melatonin
  • Drug: Placebo
    Placebo tablet was taken daily for 6 months.
Study Arms  ICMJE
  • 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.
    Intervention: Drug: Melatonin 3 mg
  • Placebo Comparator: Control group
    drug: placebo tablet; the frequency: placebo tablet was taken daily; duration: study treatment was maintained for 6 months.
    Intervention: Drug: Placebo
Publications *
  • 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.
  • Shobeiri N, Bendeck MP. Interleukin-1β 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.
  • 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.
  • 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.
  • 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: May 28, 2019) 		74
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE June 1, 2021
Estimated Primary Completion Date June 1, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 80 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE China
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03966235
Other Study ID Numbers  ICMJE MelonCAC
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: Yes
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Chen Wei Ren, MD, Chinese PLA General Hospital
Study Sponsor  ICMJE Chinese PLA General Hospital
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: yu jie zhou Beijing Anzhen Hospital
PRS Account Chinese PLA General Hospital
Verification Date May 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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