Plasma Melatonin AND Mortality After Acute Myocardial Infarction

Early-morning Plasma Melatonin Levels Predict Cardiovascular Mortality After Acute Myocardial Infarction

Pre-clinical and clinical studies have demonstrated that melatonin has cardio-protection effects. Melatonin has anti-inflammatory, antioxidant, antihypertensive, antithrombotic and antilipaemic properties, which plays important roles in a variety of cardiovascular pathophysiologic processes. Nocturnal melatonin levels decreased after AMI, and lower serum melatonin concentrations after AMI are associated with more heart failure and cardiac death and left ventricular remodeling. Moreover in women with increased BMI, lower melatonin secretion is associated with higher risks of MI. Early-morning blood collection is easier in clinical practice. Therefore, the investigators carried out a cohort study to evaluate the prognostic value of plasma soluble melatonin in hospitalized patients with acute myocardial infarction (AMI).

Study Overview

• Status: Completed
• Conditions: Myocardial Infarction; Melatonin
• Intervention / Treatment: Diagnostic test: plasma melatonin levels

• Study Type: Observational
• Enrollment (Actual): 732

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: N/A
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

A single center study on PCI-treated myocardial infarction patients

Description

Inclusion Criteria:

• consecutive patients of acute AMI come to department of cardiology, 301 hospital (Beijing, China),absent of cardiogenic shock, and survival for at least 24 h after percutaneous coronary intervention treatment.

Exclusion Criteria:

• patients with autoimmune diseases, collagen tissue diseases, drug addiction, radiotherapy, patients receiving immunosuppressive treatment, taking sedatives, antiepileptic drugs, tricyclic antidepressants or any medication known to influence melatonin metabolism, psychiatric sleeping disorders, shift workers, and subjects with jet-lag syndrome

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
cardiovascular mortality	The median follow-up was 31.6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
non-cardiovascular mortality		The median follow-up was 31.6 months
Myocardial infarction		The median follow-up was 31.6 months
heart failure readmission	readmission to any hospital due to diagnosed heart failure	The median follow-up was 31.6 months
Stroke	defined using the World Health Organization criteria	The median follow-up was 31.6 months

Collaborators and Investigators

• Sponsor: Chinese PLA General Hospital

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2013
• Primary Completion (Actual): January 1, 2015
• Study Completion (Actual): January 1, 2017

Study Registration Dates

• First Submitted: July 24, 2017
• First Submitted That Met QC Criteria: July 24, 2017
• First Posted (Actual): July 26, 2017

Study Record Updates

• Last Update Posted (Actual): July 28, 2017
• Last Update Submitted That Met QC Criteria: July 25, 2017
• Last Verified: July 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Ischemia; Pathologic Processes; Necrosis; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Myocardial Infarction; Infarction; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Central Nervous System Depressants; Protective Agents; Antioxidants; Melatonin
• Other Study ID Numbers: melatonin-AMI

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No