Plasma Melatonin AND Mortality After Acute Myocardial Infarction

July 25, 2017 updated by: Li Jing Wei, Chinese PLA General Hospital

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

Intervention / Treatment

Diagnostic test: plasma melatonin levels

Study Type

Observational

Enrollment (Actual)

732

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Chinese PLA General Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

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