<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/NCT04485988</url>
  </required_header>
  <id_info>
    <org_study_id>2020-06-25</org_study_id>
    <nct_id>NCT04485988</nct_id>
  </id_info>
  <brief_title>Influence of Beta Blockers on Prognosis in Patients With Acute Myocardial Infarction Complicated With Normal Ejection Fraction</brief_title>
  <official_title>Influence of Beta Blockers on Prognosis in Patients With Acute Myocardial Infarction Complicated With Normal Ejection Fraction</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Chongqing Medical University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Chongqing Medical University</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>
      To understand the effect of beta blockers on the prognosis of patients with acute myocardial&#xD;
      infarction with preserved ejection fraction.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The use of beta blockers is an important component of drug therapy for myocardial infarction,&#xD;
      but in some exceptional cases, evidence-based evidence for their use is insufficient, and we&#xD;
      seek to understand the prognostic impact of beta blockers on patients enrolled in long-term&#xD;
      follow-up.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">July 1, 2015</start_date>
  <completion_date type="Anticipated">July 2021</completion_date>
  <primary_completion_date type="Actual">December 2020</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>Retrospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Death</measure>
    <time_frame>The median time of 3 years</time_frame>
    <description>all-cause mortality</description>
  </primary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Anticipated">3000</enrollment>
  <condition>AMI</condition>
  <arm_group>
    <arm_group_label>No-beta blocker</arm_group_label>
  </arm_group>
  <arm_group>
    <arm_group_label>beta blocker</arm_group_label>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Beta blocker</intervention_name>
    <description>Duration of medication</description>
    <arm_group_label>beta blocker</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        The enrolled patients were from the First Affiliated Hospital of Chongqing Medical&#xD;
        University, and the patient information was obtained from the medical record system&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients with acute myocardial infarction&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Previous history of heart failure admission Killip class &gt; I class cancer pregnant&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>100 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>dongying zhang, doctor</last_name>
    <role>Principal Investigator</role>
    <affiliation>First Affiliated Hospital of Chongqing Medical University</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>dongying zhang, doctor</last_name>
    <phone>86.27.8901.1596</phone>
    <email>zhangdongying@cqmu.edu.cn</email>
  </overall_contact>
  <location>
    <facility>
      <name>The First Affiliated Hospital of Chongqing Medical University</name>
      <address>
        <city>Chongqing</city>
        <state>Chongqing</state>
        <zip>400016</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>xuesong wen, doctor</last_name>
      <phone>18702384027</phone>
      <email>1979272415@qq.com</email>
    </contact>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>June 2021</verification_date>
  <study_first_submitted>July 22, 2020</study_first_submitted>
  <study_first_submitted_qc>July 22, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 24, 2020</study_first_posted>
  <last_update_submitted>June 22, 2021</last_update_submitted>
  <last_update_submitted_qc>June 22, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">June 24, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Chongqing Medical University</investigator_affiliation>
    <investigator_full_name>Dongying Zhang</investigator_full_name>
    <investigator_title>Professor</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>Adrenergic beta-Antagonists</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/NCT04485988
org study id: 2020-06-25
nct id: NCT04485988
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
To understand the effect of beta blockers on the prognosis of patients with acute myocardial
      infarction with preserved ejection fraction.
The use of beta blockers is an important component of drug therapy for myocardial infarction,
      but in some exceptional cases, evidence-based evidence for their use is insufficient, and we
      seek to understand the prognostic impact of beta blockers on patients enrolled in long-term
      follow-up.
observational model: Cohort
time perspective: Retrospective
measure: Death
time frame: The median time of 3 years
description: all-cause mortality
arm group label: No-beta blocker
arm group label: beta blocker
intervention type: Drug
intervention name: Beta blocker
description: Duration of medication
arm group label: beta blocker
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: 100 Years
healthy volunteers: No
last name: dongying zhang, doctor
role: Principal Investigator
affiliation: First Affiliated Hospital of Chongqing Medical University
last name: dongying zhang, doctor
phone: 86.27.8901.1596
email: zhangdongying@cqmu.edu.cn
facility: 
status: Recruiting
contact: 
country: China
responsible party type: Principal Investigator
investigator affiliation: Chongqing Medical University
investigator full name: Dongying Zhang
investigator title: Professor
mesh term: Myocardial Infarction
mesh term: Infarction
mesh term: Adrenergic beta-Antagonists