xml: <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/NCT06031311</url>
    </required_header>
    <id_info>
      <org_study_id>Pulmonaryhypertension in copd</org_study_id>
      <nct_id>NCT06031311</nct_id>
    </id_info>
    <brief_title>Pulmonaryhypertension in Copd at Different Levels of Smoking</brief_title>
    <official_title>Clinical Characteristics and Predictors of Pulmonary Hypertension in COPD at Different Levels of Smoking</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Assiut University</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Assiut University</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>
        To identify Predictors of pulmonary hypertension in COPD patients and its relation to&#xD;
        different levels of smoking&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        COPD is a heterogeneous lung condition characterized by chronic respiratory symptoms&#xD;
        (dyspnea, cough, expectoration and/or exacerbations) due to abnormalities of the airways&#xD;
        (bronchitis, bronchiolitis) and/or alveoli (emphysema) that cause persistent, often&#xD;
        progressive, airflow obstruction.It is also the most common cause of deaths in patients with&#xD;
        chronic respiratory disease, the fatality rate in USA is 0.41%.Pulmonary Hypertension is the&#xD;
        most common serious complication in COPD patients ; which occurs in up to 30% of patients and&#xD;
        increases the mortality rate.Smoking is the leading cause of chronic obstructive pulmonary&#xD;
        disease (COPD) Smoking is also a trigger for COPD flare-ups.Smoking damages the air sacs,&#xD;
        airways, and the lining of your lungs. Injured lungs have trouble moving enough air in and&#xD;
        out, so it's hard to breathe&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">October 1, 2023</start_date>
    <completion_date type="Anticipated">December 1, 2024</completion_date>
    <primary_completion_date type="Anticipated">October 1, 2024</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>Predictors of pulmonary hypertension in COPD patients</measure>
      <time_frame>1 year</time_frame>
      <description>Predict pulmonary hypertension in COPD patients</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Relationship between different levels of smoking and predictors of degree of pulmonary hypertension</measure>
      <time_frame>1 year</time_frame>
      <description>Levels of smoking (mild.moderate.sever.non smoker) and it's relation to pulmonary hypertension in COPD patients</description>
    </secondary_outcome>
    <enrollment type="Anticipated">138</enrollment>
    <condition>Pulmonary Hypertension</condition>
    <intervention>
      <intervention_type>Diagnostic Test</intervention_type>
      <intervention_name>Echocardiography and HRCT</intervention_name>
      <description>Echocardiography:is non invasive and easily accessible tool in the diagnosis of any patient with suspected PH.HRCT: is a non-invasive and easily accessible tool to detect pulmonary hypertension in COPD patients.</description>
    </intervention>
    <eligibility>
      <study_pop>
        <textblock>
          Full clinical history including:[demographic data and clinical symptoms including cough&#xD;
          with expectoration ,dyspnea,chest wheeze,…etc] 2.Full clinical examination. 3.laboratory&#xD;
          investigations: Complete blood picture , kidney function test, liver function&#xD;
          test,coagulation profile 4.Arterial blood gases [Pao2, Paco2,Sao2,Hco3, P(A_a)o2 ]&#xD;
          5.PFTS:will be performed and classified into: Post bronchodilator FEV1/FVC &lt;0.7&#xD;
  &#xD;
          GOLD 1 - mild: FEV1 ≥80% predicted. GOLD 2 - moderate: 50% ≤ FEV1 &lt;80% predicted. GOLD 3 -&#xD;
          severe: 30% ≤ FEV1 &lt;50% predicted. GOLD 4 - very severe: FEV1 &lt;30% predicted [5]&#xD;
          6.Echocardiography:is non invasive and easily accessible tool in the diagnosis of any&#xD;
          patient with suspected PH. ePASP is estimated by calculating Doppler estimated trans&#xD;
          tricuspid gradient (TR gradient= 4 x (TR velocity)2) and adding estimated right atrial&#xD;
          pressure to it based on the size of the inferior vena cava and collapsibility.[6]&#xD;
        </textblock>
      </study_pop>
      <sampling_method>Non-Probability Sample</sampling_method>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  1.All patients admitted to chest department or presented to our outpatient clinic with&#xD;
               clinical and functional diagnosis of COPD among both sexes will be included 2.Age &gt;18&#xD;
               years Old&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  1.Patients under 18 years old. 2.pregnant patients. 3.patients with history&#xD;
               hypertension or valvular diseases 4.Cardiomyopathic patient 5.Patients with&#xD;
               concomitant obstructive sleep apnea 6.Patients with collagen vascular disease&#xD;
               7.Patients with thrombo-embolic disease 8. Patients with any chronic chest disease&#xD;
               other than COPD&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>100 Years</maximum_age>
    </eligibility>
    <overall_contact>
      <last_name>Shrouk Mohamed Salah, Resident physician</last_name>
      <phone>01150637673</phone>
      <email>Shrouksalah806@gmail.com</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>Marwan Nasr Sleem, Lecturer of Chest diseases and</last_name>
      <phone>01150637673</phone>
      <email>faridamarwan2014@yahoo.com</email>
    </overall_contact_backup>
    <link>
      <url>https://goldcopd.org/2023-gold-report-2/</url>
      <description>Global Initiative for Chronic Obstructive Lung Disease 2023</description>
    </link>
    <verification_date>September 2023</verification_date>
    <study_first_submitted>September 2, 2023</study_first_submitted>
    <study_first_submitted_qc>September 2, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">September 11, 2023</study_first_posted>
    <last_update_submitted>September 13, 2023</last_update_submitted>
    <last_update_submitted_qc>September 13, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 14, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Assiut University</investigator_affiliation>
      <investigator_full_name>Shrouk Mohamed Salah Mosleh</investigator_full_name>
      <investigator_title>Resident doctor</investigator_title>
    </responsible_party>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Hypertension, Pulmonary</mesh_term>
      <mesh_term>Hypertension</mesh_term>
    </condition_browse>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT06031311
  org study id: Pulmonaryhypertension in copd
  nct id: NCT06031311
  lead sponsor: 
  is fda regulated drug: No
  is fda regulated device: No
  To identify Predictors of pulmonary hypertension in COPD patients and its relation to
        different levels of smoking
  COPD is a heterogeneous lung condition characterized by chronic respiratory symptoms
        (dyspnea, cough, expectoration and/or exacerbations) due to abnormalities of the airways
        (bronchitis, bronchiolitis) and/or alveoli (emphysema) that cause persistent, often
        progressive, airflow obstruction.It is also the most common cause of deaths in patients with
        chronic respiratory disease, the fatality rate in USA is 0.41%.Pulmonary Hypertension is the
        most common serious complication in COPD patients ; which occurs in up to 30% of patients and
        increases the mortality rate.Smoking is the leading cause of chronic obstructive pulmonary
        disease (COPD) Smoking is also a trigger for COPD flare-ups.Smoking damages the air sacs,
        airways, and the lining of your lungs. Injured lungs have trouble moving enough air in and
        out, so it's hard to breathe
  observational model: Cohort
  time perspective: Prospective
  measure: Predictors of pulmonary hypertension in COPD patients
  time frame: 1 year
  description: Predict pulmonary hypertension in COPD patients
  measure: Relationship between different levels of smoking and predictors of degree of pulmonary hypertension
  time frame: 1 year
  description: Levels of smoking (mild.moderate.sever.non smoker) and it's relation to pulmonary hypertension in COPD patients
  intervention type: Diagnostic Test
  intervention name: Echocardiography and HRCT
  description: Echocardiography:is non invasive and easily accessible tool in the diagnosis of any patient with suspected PH.HRCT: is a non-invasive and easily accessible tool to detect pulmonary hypertension in COPD patients.
  study pop: 
  sampling method: Non-Probability Sample
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: 100 Years
  last name: Shrouk Mohamed Salah, Resident physician
  phone: 01150637673
  email: Shrouksalah806@gmail.com
  last name: Marwan Nasr Sleem, Lecturer of Chest diseases and
  phone: 01150637673
  email: faridamarwan2014@yahoo.com
  url: https://goldcopd.org/2023-gold-report-2/
  description: Global Initiative for Chronic Obstructive Lung Disease 2023
  responsible party type: Principal Investigator
  investigator affiliation: Assiut University
  investigator full name: Shrouk Mohamed Salah Mosleh
  investigator title: Resident doctor
  mesh term: Hypertension, Pulmonary
  mesh term: Hypertension