<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/NCT03781492</url>
  </required_header>
  <id_info>
    <org_study_id>PRESAGE Registry</org_study_id>
    <nct_id>NCT03781492</nct_id>
  </id_info>
  <brief_title>Stable Angina Management and Treatment</brief_title>
  <acronym>PRESAGE</acronym>
  <official_title>Prospective REgistry of Stable Angina manaGEment and Treatment</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Silesian Centre for Heart Diseases</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Silesian Centre for Heart Diseases</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>
      The Prospective REgistry of Stable Angina manaGEment and Treatment (PRESAGE) is an&#xD;
      observational study on an all-comer stable angina population hospitalised in a highly&#xD;
      specialized cardiovascular centre with cardiac surgery facilities. The aim of the study is to&#xD;
      assess the clinical characteristics, treatment modalities, early and long-term outcomes in&#xD;
      this population.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The Prospective REgistry of Stable Angina manaGEment and Treatment (PRESAGE) is a&#xD;
      single-center, observational study recruiting consecutive patients with stable angina, who&#xD;
      were diagnosed and treated in the 3rd Chair and Department of Cardiology in the Silesian&#xD;
      Centre for Heart Diseases in Zabrze, Poland. The Silesian Centre for Heart Diseases is a&#xD;
      highly specialised cardiology centre with cardiac surgery facilities&#xD;
&#xD;
      The main objective of the PRESAGE Registry is to clarify the overall clinical characteristics&#xD;
      of patients with stable angina, their demographics and clinical profile, current management,&#xD;
      early and long-term outcomes, with regard to the administered treatment.&#xD;
&#xD;
      The diagnosis of stable angina was based on clinical characterization, coronary angiography,&#xD;
      and the current guidelines of the European Society of Cardiology. Patients with vasospastic&#xD;
      and/or microvascular angina were also included to the registry. Performance of coronary&#xD;
      angiography is the criterion of the enrolment in the registry.&#xD;
&#xD;
      Patients with acute coronary syndromes are excluded from the analysis.&#xD;
&#xD;
      Data collection is patient-based (not event-based).&#xD;
&#xD;
      Complete patient demographics: medical history, complete hospitalization data (diagnostic and&#xD;
      therapeutic) and in-hospital results are collected in an electronic form by the attending&#xD;
      physician. The patients are under constant follow-up for all-cause mortality and major&#xD;
      cardiac adverse events.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">January 1, 2006</start_date>
  <completion_date type="Anticipated">December 31, 2026</completion_date>
  <primary_completion_date type="Anticipated">December 31, 2026</primary_completion_date>
  <study_type>Observational [Patient Registry]</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>
  <target_duration>5 Years</target_duration>
  <primary_outcome>
    <measure>Number of participants with reported deaths from any cause</measure>
    <time_frame>From date of inclusion until the date of death from any cause, assessed up to 5 year</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Number of participants with reported myocardial infarction</measure>
    <time_frame>From date of inclusion until the date of first event, assessed up to 5 year</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of participants with reported cerebrovascular insult</measure>
    <time_frame>From date of inclusion until the date of first event, assessed up to 5 year</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of participants with reported acute coronary syndrome driven revascularisation</measure>
    <time_frame>From date of inclusion until the date of first event, assessed up to 5 year</time_frame>
  </secondary_outcome>
  <enrollment type="Anticipated">25000</enrollment>
  <condition>Stable Angina</condition>
  <condition>Coronary Artery Disease</condition>
  <eligibility>
    <study_pop>
      <textblock>
        The study population is formed by all-comer patients hospitalized in cardiology ward with a&#xD;
        diagnosis of stable angina.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  symptom based diagnosis of stable angina&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  acute coronary syndrome on admission&#xD;
&#xD;
          -  ≤ 18 years old&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
  </eligibility>
  <overall_contact>
    <last_name>Piotr Desperak, MD</last_name>
    <phone>+48514374167</phone>
    <email>desperak.piotr@gmail.com</email>
  </overall_contact>
  <location>
    <facility>
      <name>3rd Chair and Department of Cardiology of Silesian Centre for Heart Diseases</name>
      <address>
        <city>Zabrze</city>
        <state>Silesia</state>
        <zip>41-800</zip>
        <country>Poland</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Mariusz Gąsior, Prof, MD, PhD</last_name>
    </contact>
  </location>
  <location_countries>
    <country>Poland</country>
  </location_countries>
  <verification_date>May 2020</verification_date>
  <study_first_submitted>December 18, 2018</study_first_submitted>
  <study_first_submitted_qc>December 18, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 20, 2018</study_first_posted>
  <last_update_submitted>May 21, 2020</last_update_submitted>
  <last_update_submitted_qc>May 21, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">May 26, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Silesian Centre for Heart Diseases</investigator_affiliation>
    <investigator_full_name>Mariusz Gasior</investigator_full_name>
    <investigator_title>Clinical Professor</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Coronary Artery Disease</mesh_term>
    <mesh_term>Angina Pectoris</mesh_term>
    <mesh_term>Angina, Stable</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/NCT03781492
org study id: PRESAGE Registry
nct id: NCT03781492
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The Prospective REgistry of Stable Angina manaGEment and Treatment (PRESAGE) is an
      observational study on an all-comer stable angina population hospitalised in a highly
      specialized cardiovascular centre with cardiac surgery facilities. The aim of the study is to
      assess the clinical characteristics, treatment modalities, early and long-term outcomes in
      this population.
The Prospective REgistry of Stable Angina manaGEment and Treatment (PRESAGE) is a
      single-center, observational study recruiting consecutive patients with stable angina, who
      were diagnosed and treated in the 3rd Chair and Department of Cardiology in the Silesian
      Centre for Heart Diseases in Zabrze, Poland. The Silesian Centre for Heart Diseases is a
      highly specialised cardiology centre with cardiac surgery facilities

      The main objective of the PRESAGE Registry is to clarify the overall clinical characteristics
      of patients with stable angina, their demographics and clinical profile, current management,
      early and long-term outcomes, with regard to the administered treatment.

      The diagnosis of stable angina was based on clinical characterization, coronary angiography,
      and the current guidelines of the European Society of Cardiology. Patients with vasospastic
      and/or microvascular angina were also included to the registry. Performance of coronary
      angiography is the criterion of the enrolment in the registry.

      Patients with acute coronary syndromes are excluded from the analysis.

      Data collection is patient-based (not event-based).

      Complete patient demographics: medical history, complete hospitalization data (diagnostic and
      therapeutic) and in-hospital results are collected in an electronic form by the attending
      physician. The patients are under constant follow-up for all-cause mortality and major
      cardiac adverse events.
observational model: Cohort
time perspective: Prospective
measure: Number of participants with reported deaths from any cause
time frame: From date of inclusion until the date of death from any cause, assessed up to 5 year
measure: Number of participants with reported myocardial infarction
time frame: From date of inclusion until the date of first event, assessed up to 5 year
measure: Number of participants with reported cerebrovascular insult
time frame: From date of inclusion until the date of first event, assessed up to 5 year
measure: Number of participants with reported acute coronary syndrome driven revascularisation
time frame: From date of inclusion until the date of first event, assessed up to 5 year
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
last name: Piotr Desperak, MD
phone: +48514374167
email: desperak.piotr@gmail.com
facility: 
status: Recruiting
contact: 
country: Poland
responsible party type: Principal Investigator
investigator affiliation: Silesian Centre for Heart Diseases
investigator full name: Mariusz Gasior
investigator title: Clinical Professor
mesh term: Coronary Artery Disease
mesh term: Angina Pectoris
mesh term: Angina, Stable
sharing ipd: No