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NCT03230630 Clinical Trial

Plasma Melatonin AND Mortality After Acute Myocardial Infarction

Myocardial Infarction Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT03230630
Other study ID # melatonin-AMI
Secondary ID
Status Completed
Phase N/A
First received July 24, 2017
Last updated July 25, 2017
Start date January 1, 2013
Est. completion date January 1, 2017

Study information
Verified date July 2017
Source Chinese PLA General Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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).

Recruitment information / eligibility
Status Completed
Enrollment 732
Est. completion date January 1, 2017
Est. primary completion date January 1, 2015
Accepts healthy volunteers
Gender All
Age group 18 Years and older
Eligibility 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 Design

Related Conditions & MeSH terms

Intervention

Diagnostic Test:
• plasma melatonin levels

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
Chinese PLA General Hospital

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