<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/NCT03297164</url>
  </required_header>
  <id_info>
    <org_study_id>2016YFC1301101</org_study_id>
    <nct_id>NCT03297164</nct_id>
  </id_info>
  <brief_title>Incidence Rate of Heart Failure After Acute Myocardial Infarction With Optimal Treatment</brief_title>
  <official_title>One Year Incidence Rate of Heart Failure After Acute Myocardial Infarction With Optimal Treatment-A Prospective,Multicenter,Cohort Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Harbin Medical University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Harbin Medical University</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The main purpose of this study is to build a multi-center, prospective and regionally&#xD;
      representative acute myocardial infarction(AMI) cohort，and build a study platform for heart&#xD;
      failure caused by AMI; To explore the 1 year incidence rate of heart failure after AMI given&#xD;
      the optimized treatment and the treatment model affecting the incidence rate of heart&#xD;
      failure, and finally to reduce the incidence rate of heart failure by 5%.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      the study aim to enroll 12000 acute myocardial infartion (AMI) patients, including ST-segment&#xD;
      elevation myocardial infarction (STEMI) and non ST-segment elevation myocardial infarction&#xD;
      (NSETMI), Patients were divided into two groups(optimized group and un-optimized group)&#xD;
      according to treatment models they accepted in 20 reginally representative hosptials of&#xD;
      China. whether optimizaed or not is judged by 4 four aspects,including emergency treatment&#xD;
      procedure, pre-infusion medication, reperfusion strategy selection, and early rehabilitation&#xD;
      after reperfusion.Patients were followed at 1 month, 6 months and 12 months. The physical&#xD;
      condition and clinical events(heart failure, death, re-infarction, revascularization,&#xD;
      apoplexy, malignant arrhythmias, bleeding events, other adverse events)were collected at&#xD;
      follow up.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">December 21, 2017</start_date>
  <completion_date type="Actual">June 30, 2021</completion_date>
  <primary_completion_date type="Actual">December 4, 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>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>incidence rate of heart failure</measure>
    <time_frame>12th month after diacharge</time_frame>
    <description>incidence rate of heart failure of acute myocardial infarction at 12th month</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>MACCE rate</measure>
    <time_frame>12th month after diacharge</time_frame>
    <description>the major adverse cardiac celebral events including death,reinfarction,</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>bleeding rate</measure>
    <time_frame>12th month after diacharge</time_frame>
    <description>the incidence rate of bleeding</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>severe adverse drug reactions</measure>
    <time_frame>12th month after diacharge</time_frame>
    <description>severe adverse drug reactions at 12th month</description>
  </secondary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Actual">12043</enrollment>
  <condition>Acute Myocardial Infarction</condition>
  <condition>Heart Failure</condition>
  <arm_group>
    <arm_group_label>optimized group</arm_group_label>
    <description>the patients in this group have been given the suggestive treatment from guideline.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>un-optimized group</arm_group_label>
    <description>the patients in this group have not been given the suggestive treatment from guideline.</description>
  </arm_group>
  <eligibility>
    <study_pop>
      <textblock>
        acute myocadial infarction&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  age≥18 years&#xD;
&#xD;
          -  diagnosed acute myocardial infarction&#xD;
&#xD;
          -  signed the informed consent form&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  AMI is caused by surgery, trauma, gastrointestinal bleeding or complications of PCI;&#xD;
&#xD;
          -  AMI occurred in patients who have been hospitalized for other reasons;&#xD;
&#xD;
          -  patients with previous history of chronic heart failure;&#xD;
&#xD;
          -  researchers judging that patient's compliance was poor and could not complete the&#xD;
             study according to the requirements.&#xD;
&#xD;
          -  life expectancy is less than 12 months;&#xD;
&#xD;
          -  heart transplant patients;&#xD;
&#xD;
          -  patients with tumors;&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Beijing An Zhen Hospital, Capital Medical University</name>
      <address>
        <city>Beijing</city>
        <state>Beijing</state>
        <zip>100029</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Peking Univerisity People'Hospital</name>
      <address>
        <city>Beijing</city>
        <state>Beijing</state>
        <zip>100044</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Beijing Chao-Yang Hospital, Capital Medical University</name>
      <address>
        <city>Beijing</city>
        <state>Beijing</state>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Peking University First Hospital</name>
      <address>
        <city>Beijing</city>
        <state>Beijing</state>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Guangdong general hospital</name>
      <address>
        <city>Guangzhou</city>
        <state>Guangdong</state>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>The first affiliated hospital of Guangxi medical university</name>
      <address>
        <city>Nanning</city>
        <state>Guangxi</state>
        <zip>530021</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Second hospital of hebei medical university</name>
      <address>
        <city>Shijiazhuang</city>
        <state>Hebei</state>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Daqing Oilfield General Hospital</name>
      <address>
        <city>Daqing</city>
        <state>Heilongjiang</state>
        <zip>163001</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>The first affiliated hospital of Zhengzhou medical university</name>
      <address>
        <city>Zhengzhou</city>
        <state>Henan</state>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Zhongda Hospital Southeast University</name>
      <address>
        <city>Nanjing</city>
        <state>Jiangsu</state>
        <zip>210009</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>The Second Affiliated Hospital of Nanchang University</name>
      <address>
        <city>Nanchang</city>
        <state>Jiangxi</state>
        <zip>330006</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>The Second Hospital of Jilin University</name>
      <address>
        <city>Changchun</city>
        <state>Jilin</state>
        <zip>130000</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>the second affiliated hospital of Dalian medical university</name>
      <address>
        <city>Dalian</city>
        <state>Liaoning</state>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Shenyang military district general hospital of the people's liberation army</name>
      <address>
        <city>Shenyang</city>
        <state>Liaoning</state>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>The first affiliated hospital of military medical university</name>
      <address>
        <city>Xi'an</city>
        <state>Shanxi</state>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Third Military Medical University</name>
      <address>
        <city>Chongqing</city>
        <state>Sichuan</state>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Tianjin Chest Hospital</name>
      <address>
        <city>Tianjing</city>
        <state>Tianjin</state>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>The General Hospital of Tianjin Medical University</name>
      <address>
        <city>Tianjin</city>
        <state>Tianjin</state>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>The First Affiliated Hospital of Xinjiang Medical University</name>
      <address>
        <city>Urumqi</city>
        <state>Xinjiang</state>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>September 2021</verification_date>
  <study_first_submitted>September 26, 2017</study_first_submitted>
  <study_first_submitted_qc>September 26, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 29, 2017</study_first_posted>
  <last_update_submitted>September 29, 2021</last_update_submitted>
  <last_update_submitted_qc>September 29, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">October 1, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Harbin Medical University</investigator_affiliation>
    <investigator_full_name>Yu Bo</investigator_full_name>
    <investigator_title>director</investigator_title>
  </responsible_party>
  <keyword>acute myocardial infarction</keyword>
  <keyword>heart failure</keyword>
  <keyword>optimized treatment</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Heart Failure</mesh_term>
    <mesh_term>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/NCT03297164
org study id: 2016YFC1301101
nct id: NCT03297164
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The main purpose of this study is to build a multi-center, prospective and regionally
      representative acute myocardial infarction(AMI) cohort，and build a study platform for heart
      failure caused by AMI; To explore the 1 year incidence rate of heart failure after AMI given
      the optimized treatment and the treatment model affecting the incidence rate of heart
      failure, and finally to reduce the incidence rate of heart failure by 5%.
the study aim to enroll 12000 acute myocardial infartion (AMI) patients, including ST-segment
      elevation myocardial infarction (STEMI) and non ST-segment elevation myocardial infarction
      (NSETMI), Patients were divided into two groups(optimized group and un-optimized group)
      according to treatment models they accepted in 20 reginally representative hosptials of
      China. whether optimizaed or not is judged by 4 four aspects,including emergency treatment
      procedure, pre-infusion medication, reperfusion strategy selection, and early rehabilitation
      after reperfusion.Patients were followed at 1 month, 6 months and 12 months. The physical
      condition and clinical events(heart failure, death, re-infarction, revascularization,
      apoplexy, malignant arrhythmias, bleeding events, other adverse events)were collected at
      follow up.
observational model: Cohort
time perspective: Prospective
measure: incidence rate of heart failure
time frame: 12th month after diacharge
description: incidence rate of heart failure of acute myocardial infarction at 12th month
measure: MACCE rate
time frame: 12th month after diacharge
description: the major adverse cardiac celebral events including death,reinfarction,
measure: bleeding rate
time frame: 12th month after diacharge
description: the incidence rate of bleeding
measure: severe adverse drug reactions
time frame: 12th month after diacharge
description: severe adverse drug reactions at 12th month
arm group label: optimized group
description: the patients in this group have been given the suggestive treatment from guideline.
arm group label: un-optimized group
description: the patients in this group have not been given the suggestive treatment from guideline.
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
facility: 
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country: China
responsible party type: Principal Investigator
investigator affiliation: Harbin Medical University
investigator full name: Yu Bo
investigator title: director
mesh term: Heart Failure
mesh term: Myocardial Infarction
mesh term: Infarction
sharing ipd: No