<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT03230630</url>
  </required_header>
  <id_info>
    <org_study_id>melatonin-AMI</org_study_id>
    <nct_id>NCT03230630</nct_id>
  </id_info>
  <brief_title>Plasma Melatonin AND Mortality After Acute Myocardial Infarction</brief_title>
  <official_title>Early-morning Plasma Melatonin Levels Predict Cardiovascular Mortality After Acute Myocardial Infarction</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Chinese PLA General Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Chinese PLA General Hospital</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Pre-clinical and clinical studies have demonstrated that melatonin has cardio-protection&#xD;
      effects. Melatonin has anti-inflammatory, antioxidant, antihypertensive, antithrombotic and&#xD;
      antilipaemic properties, which plays important roles in a variety of cardiovascular&#xD;
      pathophysiologic processes. Nocturnal melatonin levels decreased after AMI, and lower serum&#xD;
      melatonin concentrations after AMI are associated with more heart failure and cardiac death&#xD;
      and left ventricular remodeling. Moreover in women with increased BMI, lower melatonin&#xD;
      secretion is associated with higher risks of MI. Early-morning blood collection is easier in&#xD;
      clinical practice. Therefore, the investigators carried out a cohort study to evaluate the&#xD;
      prognostic value of plasma soluble melatonin in hospitalized patients with acute myocardial&#xD;
      infarction (AMI).&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 1, 2013</start_date>
  <completion_date type="Actual">January 1, 2017</completion_date>
  <primary_completion_date type="Actual">January 1, 2015</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Other</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>cardiovascular mortality</measure>
    <time_frame>The median follow-up was 31.6 months</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>non-cardiovascular mortality</measure>
    <time_frame>The median follow-up was 31.6 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Myocardial infarction</measure>
    <time_frame>The median follow-up was 31.6 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>heart failure readmission</measure>
    <time_frame>The median follow-up was 31.6 months</time_frame>
    <description>readmission to any hospital due to diagnosed heart failure</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Stroke</measure>
    <time_frame>The median follow-up was 31.6 months</time_frame>
    <description>defined using the World Health Organization criteria</description>
  </secondary_outcome>
  <enrollment type="Actual">732</enrollment>
  <condition>Melatonin</condition>
  <condition>Myocardial Infarction</condition>
  <intervention>
    <intervention_type>Diagnostic Test</intervention_type>
    <intervention_name>plasma melatonin levels</intervention_name>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        A single center study on PCI-treated myocardial infarction patients&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  consecutive patients of acute AMI come to department of cardiology, 301 hospital&#xD;
             (Beijing, China),absent of cardiogenic shock, and survival for at least 24 h after&#xD;
             percutaneous coronary intervention treatment.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  patients with autoimmune diseases, collagen tissue diseases, drug addiction,&#xD;
             radiotherapy, patients receiving immunosuppressive treatment, taking sedatives,&#xD;
             antiepileptic drugs, tricyclic antidepressants or any medication known to influence&#xD;
             melatonin metabolism, psychiatric sleeping disorders, shift workers, and subjects with&#xD;
             jet-lag syndrome&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
  </eligibility>
  <verification_date>July 2017</verification_date>
  <study_first_submitted>July 24, 2017</study_first_submitted>
  <study_first_submitted_qc>July 24, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">July 26, 2017</study_first_posted>
  <last_update_submitted>July 25, 2017</last_update_submitted>
  <last_update_submitted_qc>July 25, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">July 28, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Chinese PLA General Hospital</investigator_affiliation>
    <investigator_full_name>Li Jing Wei</investigator_full_name>
    <investigator_title>Doctor</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Myocardial Infarction</mesh_term>
    <mesh_term>Infarction</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Melatonin</mesh_term>
  </intervention_browse>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03230630
org study id: melatonin-AMI
nct id: NCT03230630
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
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).
observational model: Cohort
time perspective: Other
measure: cardiovascular mortality
time frame: The median follow-up was 31.6 months
measure: non-cardiovascular mortality
time frame: The median follow-up was 31.6 months
measure: Myocardial infarction
time frame: The median follow-up was 31.6 months
measure: heart failure readmission
time frame: The median follow-up was 31.6 months
description: readmission to any hospital due to diagnosed heart failure
measure: Stroke
time frame: The median follow-up was 31.6 months
description: defined using the World Health Organization criteria
intervention type: Diagnostic Test
intervention name: plasma melatonin levels
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
responsible party type: Principal Investigator
investigator affiliation: Chinese PLA General Hospital
investigator full name: Li Jing Wei
investigator title: Doctor
mesh term: Myocardial Infarction
mesh term: Infarction
mesh term: Melatonin