<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/NCT03276507</url>
  </required_header>
  <id_info>
    <org_study_id>EO 113/2016_FJD</org_study_id>
    <nct_id>NCT03276507</nct_id>
  </id_info>
  <brief_title>Multisystem Shortness of Breath Evaluation Study</brief_title>
  <acronym>MUSE</acronym>
  <official_title>Multisystem Shortness of Breath Evaluation Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Instituto de Investigación Sanitaria de la Fundación Jiménez Díaz</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Instituto de Investigación Sanitaria de la Fundación Jiménez Díaz</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The MUSE study is a prospective observational cohort study of patients referred to pulmonary&#xD;
      and/or cardiology specialty clinic for evaluation of shortness of breath or dyspnea. Patients&#xD;
      will undergo all pertinent testing and will be required to fill out a number of epidemiologic&#xD;
      and quality of life related questionnaires. Follow up will continue for at least one year.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">November 1, 2016</start_date>
  <completion_date type="Anticipated">June 1, 2018</completion_date>
  <primary_completion_date type="Anticipated">December 1, 2017</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>Dyspnea etiology</measure>
    <time_frame>3 months</time_frame>
    <description>All patients will undergo cardiopulmonary testing and will be offered quiestionnaires including the M3 online questionnaire</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Quality of Life</measure>
    <time_frame>6 months</time_frame>
    <description>Several questionnaires will be used including the M3 questionnaire</description>
  </secondary_outcome>
  <enrollment type="Anticipated">60</enrollment>
  <condition>Dyspnea</condition>
  <intervention>
    <intervention_type>Diagnostic Test</intervention_type>
    <intervention_name>Pulmonary function studies</intervention_name>
  </intervention>
  <intervention>
    <intervention_type>Diagnostic Test</intervention_type>
    <intervention_name>Echocardiogram</intervention_name>
  </intervention>
  <intervention>
    <intervention_type>Diagnostic Test</intervention_type>
    <intervention_name>Electrocardiogram</intervention_name>
  </intervention>
  <intervention>
    <intervention_type>Diagnostic Test</intervention_type>
    <intervention_name>Chest radiography</intervention_name>
  </intervention>
  <intervention>
    <intervention_type>Diagnostic Test</intervention_type>
    <intervention_name>Blood test</intervention_name>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Quality of life questionnaire</intervention_name>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Patients undergoing evaluation for dyspnea in a specialized clinic (Pulmonary and/or&#xD;
        Cardiology)&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients referred to Pulmonary and/or Cardiology clinic for the evaluation of&#xD;
             unexplained dyspnea.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients with a known cause of dyspnea such as established cardiopulmonary disease&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>90 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>German Peces-Barba, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Fundación Jimenez Díaz</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Luis M Seijo, MD</last_name>
    <phone>91 550 4800</phone>
    <phone_ext>2418</phone_ext>
    <email>luis.seijo@fjd.es</email>
  </overall_contact>
  <location>
    <facility>
      <name>Fundación Jimenez Díaz</name>
      <address>
        <city>Madrid</city>
        <zip>28040</zip>
        <country>Spain</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Luis M Seijo, MD</last_name>
      <phone>31 550 4800</phone>
      <phone_ext>2418</phone_ext>
      <email>luis.seijo@fjd.es</email>
    </contact>
  </location>
  <location_countries>
    <country>Spain</country>
  </location_countries>
  <verification_date>November 2017</verification_date>
  <study_first_submitted>September 7, 2017</study_first_submitted>
  <study_first_submitted_qc>September 7, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 8, 2017</study_first_posted>
  <last_update_submitted>November 8, 2017</last_update_submitted>
  <last_update_submitted_qc>November 8, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">November 9, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Instituto de Investigación Sanitaria de la Fundación Jiménez Díaz</investigator_affiliation>
    <investigator_full_name>LUIS SEIJO MACEIRAS</investigator_full_name>
    <investigator_title>Attending Physician</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Dyspnea</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/NCT03276507
org study id: EO 113/2016_FJD
nct id: NCT03276507
lead sponsor: 
has dmc: No
The MUSE study is a prospective observational cohort study of patients referred to pulmonary
      and/or cardiology specialty clinic for evaluation of shortness of breath or dyspnea. Patients
      will undergo all pertinent testing and will be required to fill out a number of epidemiologic
      and quality of life related questionnaires. Follow up will continue for at least one year.
observational model: Case-Only
time perspective: Prospective
measure: Dyspnea etiology
time frame: 3 months
description: All patients will undergo cardiopulmonary testing and will be offered quiestionnaires including the M3 online questionnaire
measure: Quality of Life
time frame: 6 months
description: Several questionnaires will be used including the M3 questionnaire
intervention type: Diagnostic Test
intervention name: Pulmonary function studies
intervention type: Diagnostic Test
intervention name: Echocardiogram
intervention type: Diagnostic Test
intervention name: Electrocardiogram
intervention type: Diagnostic Test
intervention name: Chest radiography
intervention type: Diagnostic Test
intervention name: Blood test
intervention type: Behavioral
intervention name: Quality of life questionnaire
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: 90 Years
healthy volunteers: No
last name: German Peces-Barba, MD
role: Principal Investigator
affiliation: Fundación Jimenez Díaz
last name: Luis M Seijo, MD
phone: 91 550 4800
phone ext: 2418
email: luis.seijo@fjd.es
facility: 
status: Recruiting
contact: 
country: Spain
responsible party type: Principal Investigator
investigator affiliation: Instituto de Investigación Sanitaria de la Fundación Jiménez Díaz
investigator full name: LUIS SEIJO MACEIRAS
investigator title: Attending Physician
mesh term: Dyspnea
sharing ipd: No