<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/NCT03840499</url>
  </required_header>
  <id_info>
    <org_study_id>Study survival - v. 1.0</org_study_id>
    <nct_id>NCT03840499</nct_id>
  </id_info>
  <brief_title>The Role of Willingness of Participation in Cardiology Trials on the Survival of Patients</brief_title>
  <official_title>The Role of Willingness of Participation in Cardiology Trials on the Survival of Patients</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Semmelweis University Heart and Vascular Center</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Semmelweis University Heart and Vascular Center</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>
      It has been shown retrospectively that participation and even the willingness improves the&#xD;
      survival of patients after myocardial infarction or heart failure. We aimed to prospectively&#xD;
      analyse the role of participation in cardiology trials on the survival of patients in a high&#xD;
      volumen tertiary center.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">October 1, 2018</start_date>
  <completion_date type="Anticipated">December 31, 2022</completion_date>
  <primary_completion_date type="Anticipated">December 31, 2022</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>2 Years</target_duration>
  <primary_outcome>
    <measure>All-cause mortality</measure>
    <time_frame>2-years</time_frame>
  </primary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Anticipated">400</enrollment>
  <condition>Myocardial Infarction</condition>
  <condition>Chronic Heart Failure</condition>
  <arm_group>
    <arm_group_label>Willing to participate in clinical study</arm_group_label>
  </arm_group>
  <arm_group>
    <arm_group_label>Not-willing to participate in clinical study</arm_group_label>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Optimal medical therapy</intervention_name>
    <description>Optimal medical therapy</description>
    <arm_group_label>Not-willing to participate in clinical study</arm_group_label>
    <arm_group_label>Willing to participate in clinical study</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Eligible subjects hospitalised due to myocardial infarction and or heart failure.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Hospitalisation due to acute myocardial infarction, and or heart failure&#xD;
&#xD;
          -  Singed informed consent&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Previous participation in any clinical study&#xD;
&#xD;
          -  Haemodinamically instable, shock, intubation&#xD;
&#xD;
          -  Pregnancy, breast feeding&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>85 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Semmelweis University, Heart and Vascular Center</name>
      <address>
        <city>Budapest</city>
        <zip>1122</zip>
        <country>Hungary</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>András M Boros, PhD</last_name>
      <email>borosandrasmihaly@gmail.com</email>
    </contact>
    <contact_backup>
      <phone>003614586840</phone>
    </contact_backup>
  </location>
  <location_countries>
    <country>Hungary</country>
  </location_countries>
  <verification_date>February 2019</verification_date>
  <study_first_submitted>February 12, 2019</study_first_submitted>
  <study_first_submitted_qc>February 12, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">February 15, 2019</study_first_posted>
  <last_update_submitted>February 12, 2019</last_update_submitted>
  <last_update_submitted_qc>February 12, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">February 15, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Myocardial Infarction</mesh_term>
    <mesh_term>Infarction</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/NCT03840499
org study id: Study survival - v. 1.0
nct id: NCT03840499
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
It has been shown retrospectively that participation and even the willingness improves the
      survival of patients after myocardial infarction or heart failure. We aimed to prospectively
      analyse the role of participation in cardiology trials on the survival of patients in a high
      volumen tertiary center.
observational model: Cohort
time perspective: Prospective
measure: All-cause mortality
time frame: 2-years
arm group label: Willing to participate in clinical study
arm group label: Not-willing to participate in clinical study
intervention type: Drug
intervention name: Optimal medical therapy
description: Optimal medical therapy
arm group label: Not-willing to participate in clinical study
arm group label: Willing to participate in clinical study
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: 85 Years
healthy volunteers: No
facility: 
status: Recruiting
contact: 
contact backup: 
country: Hungary
responsible party type: Sponsor
mesh term: Myocardial Infarction
mesh term: Infarction
sharing ipd: No