<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/NCT04408612</url>
  </required_header>
  <id_info>
    <org_study_id>01-05/20</org_study_id>
    <nct_id>NCT04408612</nct_id>
  </id_info>
  <brief_title>Dyspnea in Stable Patients With Coronary Artery Disease.</brief_title>
  <official_title>Dyspnea in Stable Patients With Coronary Artery Disease: Causes and Opportunities for Early Differential Diagnosis.</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>
      Single-centre prospective study to characterize causes of dyspnea in stable patients with&#xD;
      coronary artery disease and evaluate the possibility to determine the cause of dyspnea before&#xD;
      in-depth examination.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Stable patients with dyspnea and coronary artery disease will be included in this&#xD;
      single-centre prospective study. In addition to routine clinical examination patients will be&#xD;
      interviewed to determine the nature of shortness of breath, angina, presence of chronic heart&#xD;
      failure or anxiety using the Medical Research Council Dyspnea scale, the visual analog scale&#xD;
      of dyspnea, Borg scale, modified &quot;dictionary&quot; of dyspnea, G. Rose questionnaire, Seattle&#xD;
      Angina Questionnaire, Framingham criteria for chronic heart failure and the SHOCK scale.&#xD;
      During the subsequent in-depth examination including thyroid hormones, NT-proBNP, hsTroponin,&#xD;
      ECG monitoring, six-minute walk test, stress-echo with a diastolic stress test, spirometry&#xD;
      and coronary angiography (if necessary) main reason for dyspnea will be established.&#xD;
      Possibilities of early (before in-depth examination) determination the reason for dyspnea in&#xD;
      stable patients with coronary artery disease will be evaluated.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">July 6, 2020</start_date>
  <completion_date type="Anticipated">May 2023</completion_date>
  <primary_completion_date type="Anticipated">May 2023</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>Myocardial ischemia as a reason of dyspnea</measure>
    <time_frame>up to 1 month</time_frame>
    <description>Number of patient with dyspnea related to myocardial ischemia</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Other causes of dyspnea</measure>
    <time_frame>up to 1 month</time_frame>
    <description>Number of patient with non-ischemic reasons for dyspnea (heart failure, pulmonary disease, arrhythmias, psychogenic, mixed or undetermined cases).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Adverse events</measure>
    <time_frame>6 months</time_frame>
    <description>Composite of death, myocardial infarction, stroke and rehospitalization</description>
  </secondary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Anticipated">200</enrollment>
  <condition>Dyspnea</condition>
  <condition>Coronary Artery Disease</condition>
  <arm_group>
    <arm_group_label>Dyspnea in stable coronary artery disease</arm_group_label>
    <description>Stable patients with dyspnea and coronary artery disease</description>
  </arm_group>
  <intervention>
    <intervention_type>Diagnostic Test</intervention_type>
    <intervention_name>Scales for assessment of symptoms</intervention_name>
    <description>Medical Research Council Dyspnea scale, the visual analogue scale of dyspnea, Borg scale, modified &quot;dictionary&quot; of dyspnea, G. Rose questionnaire, Seattle Angina Questionnaire, Framingham criteria for chronic heart failure, the SHOCK scale.</description>
    <arm_group_label>Dyspnea in stable coronary artery disease</arm_group_label>
  </intervention>
  <biospec_retention>Samples Without DNA</biospec_retention>
  <biospec_descr>
    <textblock>
      NT-proBNP, hsTroponin&#xD;
    </textblock>
  </biospec_descr>
  <eligibility>
    <study_pop>
      <textblock>
        Stable patients with dyspnea and established coronary artery disease.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Stable patients with shortness of breath and established diagnosis of coronary artery&#xD;
             disease (at least 1 of the following signs):&#xD;
&#xD;
               -  history of myocardial infarction;&#xD;
&#xD;
               -  typical angina without suspected other cause of pain;&#xD;
&#xD;
               -  myocardial ischemia documented by ECG changes during symptoms and/or by results&#xD;
                  of the stress test;&#xD;
&#xD;
               -  coronary artery stenosis &gt;50% according to coronary angiography.&#xD;
&#xD;
          2. Signed informed consent.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Acute coronary syndrome (myocardial infarction, unstable angina) in the previous&#xD;
             month.&#xD;
&#xD;
          2. Hospitalization with decompensation of CHF in the previous 6 months (including CHF&#xD;
             decompensation as the main reason for current hospitalization).&#xD;
&#xD;
          3. Diseases with an unfavourable prognosis (terminal CKD, CHF NYHA IV, a lung disease&#xD;
             with severe respiratory failure).&#xD;
&#xD;
          4. Contraindications to bicycle stress echocardiography.&#xD;
&#xD;
          5. Atrial Fibrillation at the time of hospitalization, when the decision not to restore&#xD;
             the sinus rhythm.&#xD;
&#xD;
          6. Mental illnesses and disorders, dementia, drug or alcohol dependence.&#xD;
&#xD;
          7. Known oncological diseases.&#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_contact>
    <last_name>Sevindzh F Yarmedova</last_name>
    <phone>89637190885</phone>
    <email>gottagetaway@mail.ru</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Igor S Yavelov, MD</last_name>
    <phone>89166059047</phone>
    <email>yavelov@yahoo.com</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>National Research Centre for Therapy and Preventive Medicine</name>
      <address>
        <city>Moscow</city>
        <country>Russian Federation</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Sevindzh F Yarmedova</last_name>
    </contact>
  </location>
  <location_countries>
    <country>Russian Federation</country>
  </location_countries>
  <verification_date>March 2023</verification_date>
  <study_first_submitted>May 10, 2020</study_first_submitted>
  <study_first_submitted_qc>May 26, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">May 29, 2020</study_first_posted>
  <last_update_submitted>March 28, 2023</last_update_submitted>
  <last_update_submitted_qc>March 28, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">March 29, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Dyspnea</keyword>
  <keyword>Stable coronary artery disease</keyword>
  <keyword>Heart failure</keyword>
  <keyword>Diastolic stress test</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Dyspnea</mesh_term>
    <mesh_term>Coronary Artery Disease</mesh_term>
    <mesh_term>Myocardial Ischemia</mesh_term>
    <mesh_term>Coronary Disease</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Undecided</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/NCT04408612
org study id: 01-05/20
nct id: NCT04408612
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Single-centre prospective study to characterize causes of dyspnea in stable patients with
      coronary artery disease and evaluate the possibility to determine the cause of dyspnea before
      in-depth examination.
Stable patients with dyspnea and coronary artery disease will be included in this
      single-centre prospective study. In addition to routine clinical examination patients will be
      interviewed to determine the nature of shortness of breath, angina, presence of chronic heart
      failure or anxiety using the Medical Research Council Dyspnea scale, the visual analog scale
      of dyspnea, Borg scale, modified "dictionary" of dyspnea, G. Rose questionnaire, Seattle
      Angina Questionnaire, Framingham criteria for chronic heart failure and the SHOCK scale.
      During the subsequent in-depth examination including thyroid hormones, NT-proBNP, hsTroponin,
      ECG monitoring, six-minute walk test, stress-echo with a diastolic stress test, spirometry
      and coronary angiography (if necessary) main reason for dyspnea will be established.
      Possibilities of early (before in-depth examination) determination the reason for dyspnea in
      stable patients with coronary artery disease will be evaluated.
observational model: Case-Only
time perspective: Prospective
measure: Myocardial ischemia as a reason of dyspnea
time frame: up to 1 month
description: Number of patient with dyspnea related to myocardial ischemia
measure: Other causes of dyspnea
time frame: up to 1 month
description: Number of patient with non-ischemic reasons for dyspnea (heart failure, pulmonary disease, arrhythmias, psychogenic, mixed or undetermined cases).
measure: Adverse events
time frame: 6 months
description: Composite of death, myocardial infarction, stroke and rehospitalization
arm group label: Dyspnea in stable coronary artery disease
description: Stable patients with dyspnea and coronary artery disease
intervention type: Diagnostic Test
intervention name: Scales for assessment of symptoms
description: Medical Research Council Dyspnea scale, the visual analogue scale of dyspnea, Borg scale, modified "dictionary" of dyspnea, G. Rose questionnaire, Seattle Angina Questionnaire, Framingham criteria for chronic heart failure, the SHOCK scale.
arm group label: Dyspnea in stable coronary artery disease
NT-proBNP, hsTroponin
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: N/A
maximum age: N/A
healthy volunteers: No
last name: Sevindzh F Yarmedova
phone: 89637190885
email: gottagetaway@mail.ru
last name: Igor S Yavelov, MD
phone: 89166059047
email: yavelov@yahoo.com
facility: 
status: Recruiting
contact: 
country: Russian Federation
responsible party type: Sponsor
mesh term: Dyspnea
mesh term: Coronary Artery Disease
mesh term: Myocardial Ischemia
mesh term: Coronary Disease
sharing ipd: Undecided