Clincosm LogoSign in Get a demo

Plasma Melatonin AND Mortality After Acute Myocardial Infarction

Sponsor
Chinese PLA General Hospital (Other)
Overall Status
Completed
CT.gov ID
NCT03230630
Collaborator
(none)
732
Enrollment
48
Actual Duration (Months)

Study Details

Study Description

Brief 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).

Condition or Disease Intervention/Treatment Phase
  • Diagnostic Test: plasma melatonin levels

Study Design

Study Type:
Observational
Actual Enrollment :
732 participants
Observational Model:
Cohort
Time Perspective:
Other
Official Title:
Early-morning Plasma Melatonin Levels Predict Cardiovascular Mortality After Acute Myocardial Infarction
Actual Study Start Date :
Jan 1, 2013
Actual Primary Completion Date :
Jan 1, 2015
Actual Study Completion Date :
Jan 1, 2017

Outcome Measures

Primary Outcome Measures

  1. cardiovascular mortality [The median follow-up was 31.6 months]

Secondary Outcome Measures

  1. non-cardiovascular mortality [The median follow-up was 31.6 months]

  2. Myocardial infarction [The median follow-up was 31.6 months]

  3. heart failure readmission [The median follow-up was 31.6 months]

    readmission to any hospital due to diagnosed heart failure

  4. Stroke [The median follow-up was 31.6 months]

    defined using the World Health Organization criteria

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • Chinese PLA General Hospital

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Li Jing Wei, Doctor, Chinese PLA General Hospital
ClinicalTrials.gov Identifier:
NCT03230630
Other Study ID Numbers:
  • melatonin-AMI
First Posted:
Jul 26, 2017
Last Update Posted:
Jul 28, 2017
Last Verified:
Jul 1, 2017
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:
Myocardial Infarction
Infarction
Melatonin

Study Results

No Results Posted as of Jul 28, 2017