<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/NCT03768453</url>
  </required_header>
  <id_info>
    <org_study_id>EARLY-MYO-CMR</org_study_id>
    <nct_id>NCT03768453</nct_id>
  </id_info>
  <brief_title>EARLY-MYO-CMR Registry</brief_title>
  <official_title>EARLY-MYO-CMR (EARLY Assessment of MYOcardial Tissue Characteristics by CMR in STEMI) Registry</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>RenJi Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>RenJi 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>
      The purpose of this registry is to depict the myocardial tissue characteristics in STEMI&#xD;
      patients by CMR and other cardiac imaging modalities and to assess the prognostic value of&#xD;
      imaging-derived indices. Information will be collected prospectively in about 1000 STEMI&#xD;
      patients in 10 sites. Subjects will be followed for up to 5 years.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This is a prospective, multi-center, non-randomized, observational registry study of STEMI&#xD;
      patients that undergo CMR examination. Information of other cardiac imagings and clinical&#xD;
      outcomes are also prospectively collected in the database. This project will establish a&#xD;
      prospective registry of 1000 STEMI patients in 10 sites with follow-ups of up to 5 years.&#xD;
&#xD;
      The aim of the project will be as following:&#xD;
&#xD;
        1. To investigate myocardial tissue features and functional changes in STEMI patients.&#xD;
&#xD;
        2. To identify CMR-derived indices that are associated with adverse clinical outcomes.&#xD;
&#xD;
        3. To compare CMR with other alternative cardiac imaging modalities (i.e., echocardiography&#xD;
           or SPECT) on prognostic prediction in STEMI patients.&#xD;
&#xD;
        4. To compare myocardial tissue characteristics and functional changes in STEMI and NSTEMI&#xD;
           patients (data derived from EARLY-MYO-CMR II Registry).&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">May 8, 2012</start_date>
  <completion_date type="Anticipated">December 1, 2020</completion_date>
  <primary_completion_date type="Anticipated">July 8, 2020</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Only</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Major adverse cardiac events</measure>
    <time_frame>1 year</time_frame>
    <description>MACE</description>
  </primary_outcome>
  <enrollment type="Anticipated">1000</enrollment>
  <condition>ST-segment Elevation Myocardial Infarction (STEMI)</condition>
  <biospec_retention>None Retained</biospec_retention>
  <biospec_descr>
    <textblock>
      Routine blood test includes CBC, Liver&amp;Renal function, VBG, cardiac enzymes, glucose, serum&#xD;
      lipid etc.&#xD;
    </textblock>
  </biospec_descr>
  <eligibility>
    <study_pop>
      <textblock>
        STEMI patients undergo CMR examination are eligible for this registry.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        STEMI patients who have had CMR imaging performed and have provided written consent.&#xD;
&#xD;
          1. Patents older than 18 years old with myocardial infarction diagnosed by:&#xD;
&#xD;
               1. typical ischemic symptom,&#xD;
&#xD;
               2. New ischaemic ECG changes;: ≥2 mm ST-segment elevation in 2 contiguous precordial&#xD;
                  leads or ≥1 mm ST-segment elevation in 2 contiguous extremity leads ;&#xD;
&#xD;
               3. elevated cardiac troponin value with at least one value above 99th percentile&#xD;
                  upper reference limit(UPL);&#xD;
&#xD;
               4. confirmed by coronary angiography (CAG) or imaging evidence of new loss of viable&#xD;
                  myocardium or new regional wall motion abnormality in a pattern consistent with&#xD;
                  an ischaemic aetiology.&#xD;
&#xD;
          2. Patients who have had CMR imaging performed and have agreed to comply with the follow&#xD;
             up requirements.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Patient who is unable to comply with the follow-up schedule.&#xD;
&#xD;
          2. Patient who has any medical conditions that in the opinion of the investigators will&#xD;
             not be appropriate to participate in the study.&#xD;
&#xD;
          3. Patient has a life expectancy of less than 6 months due to any condition.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Jun Pu</last_name>
    <role>Principal Investigator</role>
    <affiliation>Renji Hospital, School of Medicine, Shanghai Jiaotong University.</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Jun Pu</last_name>
    <phone>08602168383164</phone>
    <email>pujun310@hotmail.com</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Heng Ge</last_name>
    <phone>08602168383164</phone>
    <email>dr.geheng@foxmail.com</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Ren Ji Hospital Affliated to School of Medicine, Shanghai Jiao Tong University</name>
      <address>
        <city>Shanghai</city>
        <state>Shanghai</state>
        <zip>200127</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Jun Pu, Professor</last_name>
      <phone>86-21-68383477</phone>
      <email>pujun310@hotmail.com</email>
    </contact>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>June 2019</verification_date>
  <study_first_submitted>December 3, 2018</study_first_submitted>
  <study_first_submitted_qc>December 6, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 7, 2018</study_first_posted>
  <last_update_submitted>June 19, 2020</last_update_submitted>
  <last_update_submitted_qc>June 19, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">June 23, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <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>
  <!-- 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/NCT03768453
org study id: EARLY-MYO-CMR
nct id: NCT03768453
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
The purpose of this registry is to depict the myocardial tissue characteristics in STEMI
      patients by CMR and other cardiac imaging modalities and to assess the prognostic value of
      imaging-derived indices. Information will be collected prospectively in about 1000 STEMI
      patients in 10 sites. Subjects will be followed for up to 5 years.
This is a prospective, multi-center, non-randomized, observational registry study of STEMI
      patients that undergo CMR examination. Information of other cardiac imagings and clinical
      outcomes are also prospectively collected in the database. This project will establish a
      prospective registry of 1000 STEMI patients in 10 sites with follow-ups of up to 5 years.

      The aim of the project will be as following:

        1. To investigate myocardial tissue features and functional changes in STEMI patients.

        2. To identify CMR-derived indices that are associated with adverse clinical outcomes.

        3. To compare CMR with other alternative cardiac imaging modalities (i.e., echocardiography
           or SPECT) on prognostic prediction in STEMI patients.

        4. To compare myocardial tissue characteristics and functional changes in STEMI and NSTEMI
           patients (data derived from EARLY-MYO-CMR II Registry).
observational model: Case-Only
time perspective: Prospective
measure: Major adverse cardiac events
time frame: 1 year
description: MACE
Routine blood test includes CBC, Liver&Renal function, VBG, cardiac enzymes, glucose, serum
      lipid etc.
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Jun Pu
role: Principal Investigator
affiliation: Renji Hospital, School of Medicine, Shanghai Jiaotong University.
last name: Jun Pu
phone: 08602168383164
email: pujun310@hotmail.com
last name: Heng Ge
phone: 08602168383164
email: dr.geheng@foxmail.com
facility: 
status: Recruiting
contact: 
country: China
responsible party type: Sponsor
mesh term: Myocardial Infarction
mesh term: ST Elevation Myocardial Infarction
mesh term: Infarction