NCT Number: NCT03230630
Plasma Melatonin AND 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).
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Notify MeKey information
Conditions
Age range
18 year and older
Sex eligibility
All sexes
Study type
Observational
Who can participate
Only the study team can determine whether someone qualifies for participation.
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
Treatment and study plan
Primary outcomes
-
cardiovascular mortality
Time frame: The median follow-up was 31.6 months
Secondary outcomes
-
non-cardiovascular mortality
Time frame: The median follow-up was 31.6 months
-
Myocardial infarction
Time frame: 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
-
Stroke
Time frame: The median follow-up was 31.6 months
defined using the World Health Organization criteria
Sponsors and collaborators
Lead sponsor
Chinese PLA General Hospital
Other
Registry information
Official study title
Early-morning Plasma Melatonin Levels Predict Cardiovascular Mortality After Acute Myocardial Infarction
Important dates
- Study start
- 2013
- Primary completion
- 2015
- Study completion
- 2017
- First posted
- Jul 26, 2017
- Registry last updated
- Jul 28, 2017
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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