<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/NCT03798457</url>
  </required_header>
  <id_info>
    <org_study_id>FADOI.06.2015</org_study_id>
    <nct_id>NCT03798457</nct_id>
  </id_info>
  <brief_title>Incidence and Prognostic Implication of Acute CV Events in Patients Hospitalized for CAP in Internal Medicine Units.</brief_title>
  <acronym>ICECAP</acronym>
  <official_title>Incidence and Prognostic Implication of Acute Cardiovascular Events in Patients Hospitalized for Community-acquired Pneumonia in Internal Medicine Units.The FADOI-ICECAP Study.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Fadoi Foundation, Italy</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Fadoi Foundation, Italy</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>
      FADOI-ICECAP is a observational, prospective, multicenter study involving 20-25 nationwide&#xD;
      Units of Internal Medicine. The study foresees the participation of 26 Internal Medicine&#xD;
      Operative Units, and for each of them a prospective registration of data relative to at least&#xD;
      50 patients admitted with CAP (in total, at least 1300 evaluable subjects) is foreseen.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Phase 1 - Patients enrollment (October 2016 - February 2018) Each Investigator have recorded&#xD;
      data concerning 50 patients. It will be collected general characteristics of patients,&#xD;
      clinical parameters and conditions, diagnostic imaging and blood tests,&#xD;
&#xD;
      Phase 2 - Database review and validation (April 2018 - October 2018) The data collected will&#xD;
      be analysed to process the endpoints.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">October 1, 2016</start_date>
  <completion_date type="Actual">March 28, 2018</completion_date>
  <primary_completion_date type="Actual">February 28, 2018</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>Incidence of CV events</measure>
    <time_frame>17 months</time_frame>
    <description>To assess the cumulative incidence of well defined acute CV complications during hospitalization for CAP (index event).</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Mortality</measure>
    <time_frame>18 months</time_frame>
    <description>To evaluate the impact on 30-day mortality of acute CV events occurred during hospitalization</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Impact of acute CV events</measure>
    <time_frame>18 months</time_frame>
    <description>To assess the impact of acute CV events occurred during hospitalization on the risk of hospital readmission within 30 days</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Impact of CV events</measure>
    <time_frame>18 months</time_frame>
    <description>To assess the impact of CV events on the length of hospitalization</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Risk factor</measure>
    <time_frame>18 months</time_frame>
    <description>To evaluate risk factors for the occurrence of acute CV events</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Incidence of CV events in patients without history of heart failure, acute coronary syndrome, cerebrovascular disease, or clinically relevant arrhythmia</measure>
    <time_frame>18 months</time_frame>
    <description>To evaluate the incidence of CV complications in the group of patients without history of heart failure, acute coronary syndrome, cerebrovascular disease, or clinically relevant arrhythmia</description>
  </secondary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">1266</enrollment>
  <condition>Cardiovascular Events</condition>
  <arm_group>
    <arm_group_label>Patients with CAP hospitalized in IM</arm_group_label>
    <description>Data of Patients with Community-acquired pneumonia (CAP) hospitalized in Internal Medicine Units will be collected for this study; no intervention is planned for this study</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>No intervention</intervention_name>
    <description>In this study there is no intervention</description>
    <arm_group_label>Patients with CAP hospitalized in IM</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Patients with Community-acquired pneumonia (CAP) hospitalized in Internal Medicine Units&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Age &gt; 18 years&#xD;
&#xD;
          2. Diagnosis of pneumonia defined by the presence on chest X-ray or CT-scan of lung of&#xD;
             new infiltration associated with at least two of the following clinical features:&#xD;
&#xD;
               -  fever &gt; 37.8°C&#xD;
&#xD;
               -  typical symptoms (dyspnea, productive cough, pain)&#xD;
&#xD;
               -  typical clinical signs on chest examination (crepitation, bronchial breathing,&#xD;
                  pleural effusion)&#xD;
&#xD;
               -  leukocytosis&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  patients with Hospital-Acquired Pneumonia (HAP) (i.e. those patients with pneumonia&#xD;
             acquired in hospital more than 48 hours after admission)&#xD;
&#xD;
          -  patients with tuberculosis in active phase&#xD;
&#xD;
          -  patients with cystic fibrosis&#xD;
&#xD;
          -  patients who refuse to participate in the study and/or to give the written informed&#xD;
             consent.&#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>Gualberto Gussoni, MD</last_name>
    <role>Study Director</role>
    <affiliation>Fadoi Foundation</affiliation>
  </overall_official>
  <verification_date>January 2019</verification_date>
  <study_first_submitted>December 28, 2018</study_first_submitted>
  <study_first_submitted_qc>January 8, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 10, 2019</study_first_posted>
  <last_update_submitted>January 8, 2019</last_update_submitted>
  <last_update_submitted_qc>January 8, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">January 10, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Community-acquired pneumonia (CAP)</keyword>
  <!-- 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/NCT03798457
org study id: FADOI.06.2015
nct id: NCT03798457
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
FADOI-ICECAP is a observational, prospective, multicenter study involving 20-25 nationwide
      Units of Internal Medicine. The study foresees the participation of 26 Internal Medicine
      Operative Units, and for each of them a prospective registration of data relative to at least
      50 patients admitted with CAP (in total, at least 1300 evaluable subjects) is foreseen.
Phase 1 - Patients enrollment (October 2016 - February 2018) Each Investigator have recorded
      data concerning 50 patients. It will be collected general characteristics of patients,
      clinical parameters and conditions, diagnostic imaging and blood tests,

      Phase 2 - Database review and validation (April 2018 - October 2018) The data collected will
      be analysed to process the endpoints.
observational model: Cohort
time perspective: Prospective
measure: Incidence of CV events
time frame: 17 months
description: To assess the cumulative incidence of well defined acute CV complications during hospitalization for CAP (index event).
measure: Mortality
time frame: 18 months
description: To evaluate the impact on 30-day mortality of acute CV events occurred during hospitalization
measure: Impact of acute CV events
time frame: 18 months
description: To assess the impact of acute CV events occurred during hospitalization on the risk of hospital readmission within 30 days
measure: Impact of CV events
time frame: 18 months
description: To assess the impact of CV events on the length of hospitalization
measure: Risk factor
time frame: 18 months
description: To evaluate risk factors for the occurrence of acute CV events
measure: Incidence of CV events in patients without history of heart failure, acute coronary syndrome, cerebrovascular disease, or clinically relevant arrhythmia
time frame: 18 months
description: To evaluate the incidence of CV complications in the group of patients without history of heart failure, acute coronary syndrome, cerebrovascular disease, or clinically relevant arrhythmia
arm group label: Patients with CAP hospitalized in IM
description: Data of Patients with Community-acquired pneumonia (CAP) hospitalized in Internal Medicine Units will be collected for this study; no intervention is planned for this study
intervention type: Other
intervention name: No intervention
description: In this study there is no intervention
arm group label: Patients with CAP hospitalized in IM
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Gualberto Gussoni, MD
role: Study Director
affiliation: Fadoi Foundation
responsible party type: Sponsor