<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/NCT03306303</url>
  </required_header>
  <id_info>
    <org_study_id>MelandNR</org_study_id>
    <nct_id>NCT03306303</nct_id>
  </id_info>
  <brief_title>Association Between Plasma Melatonin and No-reflow</brief_title>
  <official_title>Association Between Plasma Melatonin and No-reflow</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>
      ST-segment elevation myocardial infarction (STEMI) is an acute manifestation of coronary&#xD;
      heart disease, remaining a frequent cause of death. A better understanding of risk factors&#xD;
      and pathogenic mechanisms underlying STEMI may help improve the prognosis and life quality of&#xD;
      these patients. Melatonin is the chief indoleamine produced by the pineal gland, and a&#xD;
      well-known antioxidant and free radical scavenger. Basic studies have showed that melatonin&#xD;
      is associated with myocardial infarction and heart failure. However, no study has evaluated&#xD;
      whether melatonin is associated with adverse clinical outcomes in STEMI patients.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 1, 2014</start_date>
  <completion_date type="Actual">October 1, 2017</completion_date>
  <primary_completion_date type="Actual">October 1, 2017</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>a change in the prevalence of no-reflow</measure>
    <time_frame>mediately after percutaneous coronary intervention (PCI)</time_frame>
    <description>Thrombolysis in myocardial infarction (TIMI) flow grade of &lt;3 with a myocardial blush grade of 0-1 was defined as angiographic no-reflow</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>in-hospital complications</measure>
    <time_frame>up to 2 weeks after PCI</time_frame>
    <description>defined as acute heart failure, atrial fibrillation, chest pain or recurrence of myocardial infarction, complete atrioventricular block, cerebrovascular disease, ventricular fibrillation or ventricular tachycardia</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>in-hospital major adverse cardiac or cerebrovascular events</measure>
    <time_frame>up to 2 weeks after PCI</time_frame>
    <description>the composite of death, nonfatal MI, or stroke</description>
  </secondary_outcome>
  <number_of_groups>4</number_of_groups>
  <enrollment type="Actual">1700</enrollment>
  <condition>ST-segment Elevation Myocardial Infarction</condition>
  <arm_group>
    <arm_group_label>Quartile 1 of plasma melatonin</arm_group_label>
    <description>Quartile 1 of plasma melatonin</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Quartile 2 of plasma melatonin</arm_group_label>
    <description>Quartile 2 of plasma melatonin</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Quartile 3 of plasma melatonin</arm_group_label>
    <description>Quartile 3 of plasma melatonin</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Quartile 4 of plasma melatonin</arm_group_label>
    <description>Quartile 4 of plasma melatonin</description>
  </arm_group>
  <biospec_retention>Samples Without DNA</biospec_retention>
  <biospec_descr>
    <textblock>
      melatonin, high-sensitivity C-reactive protein (hsCRP), superoxide dismutase levels&#xD;
    </textblock>
  </biospec_descr>
  <eligibility>
    <study_pop>
      <textblock>
        PLA general hospital (PLAGH) is a large national tertiary-care center in the Beijing,&#xD;
        China. The investigators enrolled all patients consecutively hospitalized in PLAGH, with a&#xD;
        diagnosis of STEMI and needed PCI.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        a diagnosis of STEMI and needed PCI&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        patients with cancer patients who used melatonin&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>80 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <reference>
    <citation>Dominguez-Rodriguez A, Abreu-Gonzalez P, Arroyo-Ucar E, Reiter RJ. Decreased level of melatonin in serum predicts left ventricular remodelling after acute myocardial infarction. J Pineal Res. 2012 Oct;53(3):319-23. doi: 10.1111/j.1600-079X.2012.01001.x. Epub 2012 Apr 27.</citation>
    <PMID>22537272</PMID>
  </reference>
  <reference>
    <citation>Dominguez-Rodriguez A, Abreu-Gonzalez P, Reiter RJ. The potential usefulness of serum melatonin level to predict heart failure in patients with hypertensive cardiomyopathy. Int J Cardiol. 2014 Jun 15;174(2):415-7. doi: 10.1016/j.ijcard.2014.04.044. Epub 2014 Apr 15. No abstract available.</citation>
    <PMID>24768380</PMID>
  </reference>
  <reference>
    <citation>Tutuncu NB, Batur MK, Yildirir A, Tutuncu T, Deger A, Koray Z, Erbas B, Kabakci G, Aksoyek S, Erbas T. Melatonin levels decrease in type 2 diabetic patients with cardiac autonomic neuropathy. J Pineal Res. 2005 Aug;39(1):43-9. doi: 10.1111/j.1600-079X.2005.00213.x.</citation>
    <PMID>15978056</PMID>
  </reference>
  <verification_date>October 2017</verification_date>
  <study_first_submitted>October 2, 2017</study_first_submitted>
  <study_first_submitted_qc>October 4, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">October 11, 2017</study_first_posted>
  <last_update_submitted>October 4, 2017</last_update_submitted>
  <last_update_submitted_qc>October 4, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">October 11, 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>Chen Wei Ren, MD</investigator_full_name>
    <investigator_title>Doctor</investigator_title>
  </responsible_party>
  <keyword>melatonin</keyword>
  <keyword>STEMI</keyword>
  <keyword>No-reflow</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Myocardial Infarction</mesh_term>
    <mesh_term>ST Elevation Myocardial Infarction</mesh_term>
    <mesh_term>Infarction</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- 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/NCT03306303
org study id: MelandNR
nct id: NCT03306303
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
ST-segment elevation myocardial infarction (STEMI) is an acute manifestation of coronary
      heart disease, remaining a frequent cause of death. A better understanding of risk factors
      and pathogenic mechanisms underlying STEMI may help improve the prognosis and life quality of
      these patients. Melatonin is the chief indoleamine produced by the pineal gland, and a
      well-known antioxidant and free radical scavenger. Basic studies have showed that melatonin
      is associated with myocardial infarction and heart failure. However, no study has evaluated
      whether melatonin is associated with adverse clinical outcomes in STEMI patients.
observational model: Cohort
time perspective: Other
measure: a change in the prevalence of no-reflow
time frame: mediately after percutaneous coronary intervention (PCI)
description: Thrombolysis in myocardial infarction (TIMI) flow grade of <3 with a myocardial blush grade of 0-1 was defined as angiographic no-reflow
measure: in-hospital complications
time frame: up to 2 weeks after PCI
description: defined as acute heart failure, atrial fibrillation, chest pain or recurrence of myocardial infarction, complete atrioventricular block, cerebrovascular disease, ventricular fibrillation or ventricular tachycardia
measure: in-hospital major adverse cardiac or cerebrovascular events
time frame: up to 2 weeks after PCI
description: the composite of death, nonfatal MI, or stroke
arm group label: Quartile 1 of plasma melatonin
description: Quartile 1 of plasma melatonin
arm group label: Quartile 2 of plasma melatonin
description: Quartile 2 of plasma melatonin
arm group label: Quartile 3 of plasma melatonin
description: Quartile 3 of plasma melatonin
arm group label: Quartile 4 of plasma melatonin
description: Quartile 4 of plasma melatonin
melatonin, high-sensitivity C-reactive protein (hsCRP), superoxide dismutase levels
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: 80 Years
healthy volunteers: No
citation: Dominguez-Rodriguez A, Abreu-Gonzalez P, Arroyo-Ucar E, Reiter RJ. Decreased level of melatonin in serum predicts left ventricular remodelling after acute myocardial infarction. J Pineal Res. 2012 Oct;53(3):319-23. doi: 10.1111/j.1600-079X.2012.01001.x. Epub 2012 Apr 27.
PMID: 22537272
citation: Dominguez-Rodriguez A, Abreu-Gonzalez P, Reiter RJ. The potential usefulness of serum melatonin level to predict heart failure in patients with hypertensive cardiomyopathy. Int J Cardiol. 2014 Jun 15;174(2):415-7. doi: 10.1016/j.ijcard.2014.04.044. Epub 2014 Apr 15. No abstract available.
PMID: 24768380
citation: Tutuncu NB, Batur MK, Yildirir A, Tutuncu T, Deger A, Koray Z, Erbas B, Kabakci G, Aksoyek S, Erbas T. Melatonin levels decrease in type 2 diabetic patients with cardiac autonomic neuropathy. J Pineal Res. 2005 Aug;39(1):43-9. doi: 10.1111/j.1600-079X.2005.00213.x.
PMID: 15978056
responsible party type: Principal Investigator
investigator affiliation: Chinese PLA General Hospital
investigator full name: Chen Wei Ren, MD
investigator title: Doctor
mesh term: Myocardial Infarction
mesh term: ST Elevation Myocardial Infarction
mesh term: Infarction
sharing ipd: No