<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/NCT04400500</url>
  </required_header>
  <id_info>
    <org_study_id>01-02/20</org_study_id>
    <nct_id>NCT04400500</nct_id>
  </id_info>
  <brief_title>Differential Diagnosis and Risk Stratification in Patients With Suspected NSTEACS</brief_title>
  <official_title>Approaches to Differential Diagnosis and Risk Stratification in Patients Hospitalized With Suspected Acute Coronary Syndrome Without Persistent ST-segment 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>Yes</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>
      To evaluate possibilities of rapid differential diagnosis and risk stratification in patients&#xD;
      urgently admitted to the CCU with a suspected acute coronary syndrome without persistent&#xD;
      ST-segment elevation (NSTEACS).&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Single centre prospective non-randomised non-comparative study of patients delivered by&#xD;
      ambulance and admitted to the CCU with suspected NSTEACS.&#xD;
&#xD;
      Aims of this study are:&#xD;
&#xD;
        1. To characterize the contingent of patients admitted to the CCU with suspected NSTEACS.&#xD;
&#xD;
        2. To evaluate possibilities of fast differential diagnosis and risk stratification in&#xD;
           patients admitted to the CCU with suspected NSTEACS using clinical data, ECG, biomarker&#xD;
           levels (hsTn, NT-proBNP, hsCPR, cardiac FABP) as well as HEART, ADAPT, EDACS, T-MACS,&#xD;
           GRACE, ACTION and TIMI scores.&#xD;
&#xD;
        3. To evaluate the correlation between clinical data, ECG, biomarker levels (hsTn,&#xD;
           NT-proBNP, hsCPR, cardiac FABP) as well as HEART, ADAPT, EDACS, T-MACS, GRACE, ACTION&#xD;
           and TIMI scores with presence and severity of coronary atherosclerosis in patients&#xD;
           admitted to the CCU (intensive care unit) with suspected NSTEACS.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">March 1, 2020</start_date>
  <completion_date type="Anticipated">September 30, 2023</completion_date>
  <primary_completion_date type="Anticipated">April 30, 2023</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>Clinical outcomes</measure>
    <time_frame>6 monts</time_frame>
    <description>Composite of death, (re) infarction, stroke or re-hospitalization</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Final diagnosis</measure>
    <time_frame>Up to 1 monts</time_frame>
    <description>Final diagnosis - the main reason for urgent hospitalization - according to hospital case history</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Death</measure>
    <time_frame>6 months.</time_frame>
    <description>Death upon discharge and up to 6 months</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>(re) infarction</measure>
    <time_frame>Up to 1 monts</time_frame>
    <description>(re) infarction upon discharge and up to 6 months</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Stroke</measure>
    <time_frame>6 months.</time_frame>
    <description>Stroke upon discharge and up to 6 months</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Re-hospitalization</measure>
    <time_frame>6 months.</time_frame>
    <description>Recurrent hospital admissions after discharge form the index hospitalization</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Urgent revascularisation</measure>
    <time_frame>Up to 1 monts</time_frame>
    <description>Revascularisation performed due to sudden clinical deterioration</description>
  </other_outcome>
  <other_outcome>
    <measure>Other adverse events</measure>
    <time_frame>6 months.</time_frame>
    <description>All adverse events/complications not included in clinical outcomes end points.</description>
  </other_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Anticipated">140</enrollment>
  <condition>Non ST Segment Elevation Acute Coronary Syndrome</condition>
  <arm_group>
    <arm_group_label>Suspected NSTEACS</arm_group_label>
    <description>Patients urgently admitted to the CCU with suspected NSTEACS</description>
  </arm_group>
  <intervention>
    <intervention_type>Diagnostic Test</intervention_type>
    <intervention_name>Approaches to differential diagnosis and risk stratification</intervention_name>
    <description>Detailed analysis of clinical course, ECG, biomarkers (hsTn I, CK-MB mass, myoglobin, NT-proBNP, hsCPR, cardiac FABP on admission and after 3 hours; hsTn I, CK-MB mass and myoglobin after 6 hours if needed) as well as HEART, ADAPT, EDACS, T-MACS, GRACE, ACTION and TIMI scores.</description>
    <arm_group_label>Suspected NSTEACS</arm_group_label>
  </intervention>
  <biospec_retention>Samples Without DNA</biospec_retention>
  <biospec_descr>
    <textblock>
      hsTn, NT-proBNP, hsCPR, cardiac FABP&#xD;
    </textblock>
  </biospec_descr>
  <eligibility>
    <study_pop>
      <textblock>
        Patients delivered by ambulance and admitted to the CCU with suspected diagnosis &quot;acute&#xD;
        coronary syndrome (ACS)&quot;.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Delivered by ambulance to the CCU with suspected diagnosis &quot;acute coronary syndrome&#xD;
             (ACS)&quot;.&#xD;
&#xD;
          2. Signed informed consent.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. ACS with persistent ST-segment elevation.&#xD;
&#xD;
          2. Moribund; extremely severe condition on admission with a potentially unfavourable&#xD;
             prognosis (cardiogenic shock, coma, cardiac arrest, an urgent need for mechanical&#xD;
             ventilation).&#xD;
&#xD;
          3. Overt non-cardiac cause of clinical manifestations at the time of admission (bleeding,&#xD;
             pulmonary embolism, aortic dissection, stroke).&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Igor S Yavelov, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>National Medical Research Center for Therapy and Preventive Medicine</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Vitaliy A Moshanov, RA</last_name>
    <phone>79175694724</phone>
    <email>moshanov.vitalii@mail.ru</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Igor S Yavelov, PhD</last_name>
    <phone>79166059047</phone>
    <email>yavelov@yahoo.com</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Eramishantsev Hospital</name>
      <address>
        <city>Moscow</city>
        <country>Russian Federation</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location_countries>
    <country>Russian Federation</country>
  </location_countries>
  <verification_date>March 2023</verification_date>
  <study_first_submitted>April 23, 2020</study_first_submitted>
  <study_first_submitted_qc>May 19, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">May 22, 2020</study_first_posted>
  <last_update_submitted>March 23, 2023</last_update_submitted>
  <last_update_submitted_qc>March 23, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">March 24, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Non ST segment Elevation Acute Coronary Syndrome</keyword>
  <keyword>Diagnosis</keyword>
  <keyword>Prognosis</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Acute Coronary Syndrome</mesh_term>
    <mesh_term>Syndrome</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/NCT04400500
org study id: 01-02/20
nct id: NCT04400500
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
To evaluate possibilities of rapid differential diagnosis and risk stratification in patients
      urgently admitted to the CCU with a suspected acute coronary syndrome without persistent
      ST-segment elevation (NSTEACS).
Single centre prospective non-randomised non-comparative study of patients delivered by
      ambulance and admitted to the CCU with suspected NSTEACS.

      Aims of this study are:

        1. To characterize the contingent of patients admitted to the CCU with suspected NSTEACS.

        2. To evaluate possibilities of fast differential diagnosis and risk stratification in
           patients admitted to the CCU with suspected NSTEACS using clinical data, ECG, biomarker
           levels (hsTn, NT-proBNP, hsCPR, cardiac FABP) as well as HEART, ADAPT, EDACS, T-MACS,
           GRACE, ACTION and TIMI scores.

        3. To evaluate the correlation between clinical data, ECG, biomarker levels (hsTn,
           NT-proBNP, hsCPR, cardiac FABP) as well as HEART, ADAPT, EDACS, T-MACS, GRACE, ACTION
           and TIMI scores with presence and severity of coronary atherosclerosis in patients
           admitted to the CCU (intensive care unit) with suspected NSTEACS.
observational model: Cohort
time perspective: Prospective
measure: Clinical outcomes
time frame: 6 monts
description: Composite of death, (re) infarction, stroke or re-hospitalization
measure: Final diagnosis
time frame: Up to 1 monts
description: Final diagnosis - the main reason for urgent hospitalization - according to hospital case history
measure: Death
time frame: 6 months.
description: Death upon discharge and up to 6 months
measure: (re) infarction
time frame: Up to 1 monts
description: (re) infarction upon discharge and up to 6 months
measure: Stroke
time frame: 6 months.
description: Stroke upon discharge and up to 6 months
measure: Re-hospitalization
time frame: 6 months.
description: Recurrent hospital admissions after discharge form the index hospitalization
measure: Urgent revascularisation
time frame: Up to 1 monts
description: Revascularisation performed due to sudden clinical deterioration
measure: Other adverse events
time frame: 6 months.
description: All adverse events/complications not included in clinical outcomes end points.
arm group label: Suspected NSTEACS
description: Patients urgently admitted to the CCU with suspected NSTEACS
intervention type: Diagnostic Test
intervention name: Approaches to differential diagnosis and risk stratification
description: Detailed analysis of clinical course, ECG, biomarkers (hsTn I, CK-MB mass, myoglobin, NT-proBNP, hsCPR, cardiac FABP on admission and after 3 hours; hsTn I, CK-MB mass and myoglobin after 6 hours if needed) as well as HEART, ADAPT, EDACS, T-MACS, GRACE, ACTION and TIMI scores.
arm group label: Suspected NSTEACS
hsTn, NT-proBNP, hsCPR, cardiac FABP
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: N/A
maximum age: N/A
healthy volunteers: No
last name: Igor S Yavelov, PhD
role: Principal Investigator
affiliation: National Medical Research Center for Therapy and Preventive Medicine
last name: Vitaliy A Moshanov, RA
phone: 79175694724
email: moshanov.vitalii@mail.ru
last name: Igor S Yavelov, PhD
phone: 79166059047
email: yavelov@yahoo.com
facility: 
status: Recruiting
country: Russian Federation
responsible party type: Sponsor
mesh term: Acute Coronary Syndrome
mesh term: Syndrome
sharing ipd: No