<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/NCT04490928</url>
  </required_header>
  <id_info>
    <org_study_id>10-19/19</org_study_id>
    <nct_id>NCT04490928</nct_id>
  </id_info>
  <brief_title>The Problem of Incomplete Myocardial Revascularization in Percutaneous Coronary Intervention in Patients With NSTEMI</brief_title>
  <acronym>CONTRAST</acronym>
  <official_title>The Problem of Incomplete Myocardial Revascularization in Percutaneous Coronary Intervention in Patients With Acute Coronary Syndrome Non-ST-elevation</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>National Research Center for Preventive Medicine</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>National Medical Research Center for Therapy and Preventive Medicine</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 study included all patients admitted to the intensive care unit of the district hospital&#xD;
      and sent to the angiographic Department for diagnosis and performance of PCI with a diagnosis&#xD;
      of NSTEMI, including myocardial infarction (mi) and unstable angina, determined by clinical&#xD;
      data, ECG signs and laboratory indicators. Data from patients living in the Sergiev Posad&#xD;
      municipal district will be analyzed in order to achieve maximum registration of adverse&#xD;
      events during one year of follow-up.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Objective: to investigate the problem of incomplete myocardial revascularization in&#xD;
      percutaneous coronary interventions in patients with acute coronary syndrome without St&#xD;
      segment elevation who were admitted to the angiographic Department of the Sergiev Posad city&#xD;
      hospital in the Moscow region.&#xD;
&#xD;
      The study will include all patients admitted to the intensive care unit of the regional&#xD;
      hospital and sent to the angiographic Department for diagnosis and performance of PCI with&#xD;
      acute coronary syndrome NSTEMI, including myocardial infarction (mi) and unstable angina,&#xD;
      determined by clinical data, ECG signs and laboratory indicators. Anamnestic, clinical,&#xD;
      biochemical indicators, cardiovascular risk factors, comorbid index that determines the&#xD;
      course of acute coronary syndrome and prognosis (grace), a number of angiographic data,&#xD;
      including the number of affected arteries and variants of the index &quot;syntax score 50&quot; and&#xD;
      modified &quot;syntax score 30&quot;, &quot;syntax score 70&quot; and&quot; syntax score 90&quot; to separate complete and&#xD;
      incomplete revascularization, an integral indicator of the quality of the remaining index&#xD;
      Syntex, the absolute value of which is corrected during data analysis. The data of patients&#xD;
      living in the city of Sergiev Posad will be reviewed in such a way as to minimize the&#xD;
      subsequent year of follow-up, using a telephone survey and the EMIAS electronic system&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">November 1, 2018</start_date>
  <completion_date type="Actual">July 28, 2020</completion_date>
  <primary_completion_date type="Actual">February 28, 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>Time to non- fatal myocardial infarction, stroke, repeated hospitalizations for cardiovascular reasons, repeated PCI, CABG, cardiovascular death or death from all-cause</measure>
    <time_frame>12 months</time_frame>
    <description>Primary Outcome Measures will be evaluated 12 months after the patient is discharged from the hospital</description>
  </primary_outcome>
  <number_of_groups>3</number_of_groups>
  <enrollment type="Actual">139</enrollment>
  <condition>NSTEMI</condition>
  <arm_group>
    <arm_group_label>complete revascularization</arm_group_label>
    <description>All patients who underwent complete myocardial revascularization</description>
  </arm_group>
  <arm_group>
    <arm_group_label>incomplete revascularization</arm_group_label>
    <description>All patients who did not complete myocardial revascularization</description>
  </arm_group>
  <arm_group>
    <arm_group_label>without revascularization</arm_group_label>
    <description>All patients who were not revascularized</description>
  </arm_group>
  <eligibility>
    <study_pop>
      <textblock>
        All patients were admitted to the intensive care unit of the district hospital from&#xD;
        November 2018 to February 2019 and sent to the angiographic Department for diagnosis and&#xD;
        performance of PCI with a diagnosis of NSTEMI, including myocardial infarction (mi) and&#xD;
        unstable angina, determined by clinical data, ECG signs and laboratory indicators. Data&#xD;
        from patients living in the Sergiev Posad municipal district will be analyzed in order to&#xD;
        achieve maximum registration of adverse events during one year of follow-up. (Included in&#xD;
        the registry profile)&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        - All patients who were referred to an angiographic unit with a diagnosis of NSTEMI for&#xD;
        diagnostic coronary angiography and/or PCI from November 2018 to February 2019.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients with myocardial infarction with ECG- confirmed ST elevation of more than 1 mm&#xD;
             in two leads.&#xD;
&#xD;
          -  Residents of areas other than the area in question that may be difficult to contact.&#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>Vladimir Mazaev</last_name>
    <role>Study Director</role>
    <affiliation>National Research Center for Therapy and Preventive Medicine</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Sergiyev Posad city hospital</name>
      <address>
        <city>Sergiyev Posad</city>
        <state>Moscow Region</state>
        <zip>141301</zip>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Russian Federation</country>
  </location_countries>
  <verification_date>September 2020</verification_date>
  <study_first_submitted>July 24, 2020</study_first_submitted>
  <study_first_submitted_qc>July 28, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 29, 2020</study_first_posted>
  <last_update_submitted>September 21, 2020</last_update_submitted>
  <last_update_submitted_qc>September 21, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">September 22, 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>Non-ST Elevated Myocardial 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/NCT04490928
org study id: 10-19/19
nct id: NCT04490928
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The study included all patients admitted to the intensive care unit of the district hospital
      and sent to the angiographic Department for diagnosis and performance of PCI with a diagnosis
      of NSTEMI, including myocardial infarction (mi) and unstable angina, determined by clinical
      data, ECG signs and laboratory indicators. Data from patients living in the Sergiev Posad
      municipal district will be analyzed in order to achieve maximum registration of adverse
      events during one year of follow-up.
Objective: to investigate the problem of incomplete myocardial revascularization in
      percutaneous coronary interventions in patients with acute coronary syndrome without St
      segment elevation who were admitted to the angiographic Department of the Sergiev Posad city
      hospital in the Moscow region.

      The study will include all patients admitted to the intensive care unit of the regional
      hospital and sent to the angiographic Department for diagnosis and performance of PCI with
      acute coronary syndrome NSTEMI, including myocardial infarction (mi) and unstable angina,
      determined by clinical data, ECG signs and laboratory indicators. Anamnestic, clinical,
      biochemical indicators, cardiovascular risk factors, comorbid index that determines the
      course of acute coronary syndrome and prognosis (grace), a number of angiographic data,
      including the number of affected arteries and variants of the index "syntax score 50" and
      modified "syntax score 30", "syntax score 70" and" syntax score 90" to separate complete and
      incomplete revascularization, an integral indicator of the quality of the remaining index
      Syntex, the absolute value of which is corrected during data analysis. The data of patients
      living in the city of Sergiev Posad will be reviewed in such a way as to minimize the
      subsequent year of follow-up, using a telephone survey and the EMIAS electronic system
observational model: Cohort
time perspective: Retrospective
measure: Time to non- fatal myocardial infarction, stroke, repeated hospitalizations for cardiovascular reasons, repeated PCI, CABG, cardiovascular death or death from all-cause
time frame: 12 months
description: Primary Outcome Measures will be evaluated 12 months after the patient is discharged from the hospital
arm group label: complete revascularization
description: All patients who underwent complete myocardial revascularization
arm group label: incomplete revascularization
description: All patients who did not complete myocardial revascularization
arm group label: without revascularization
description: All patients who were not revascularized
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Vladimir Mazaev
role: Study Director
affiliation: National Research Center for Therapy and Preventive Medicine
facility: 
country: Russian Federation
responsible party type: Sponsor
mesh term: Non-ST Elevated Myocardial Infarction
sharing ipd: No