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/NCT06031974</url>
    </required_header>
    <id_info>
      <org_study_id>2.25/III/23</org_study_id>
      <nct_id>NCT06031974</nct_id>
    </id_info>
    <brief_title>Dietary Intervention to Stop Coronary Atherosclerosis in Computed Tomography: Long-Term Follow-Up</brief_title>
    <acronym>DISCO-CT2</acronym>
    <official_title>Dietary Intervention to Stop Coronary Atherosclerosis in Computed Tomography: Long-Term Follow-Up</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>National Institute of Cardiology, Warsaw, Poland</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>National Institute of Cardiology, Warsaw, Poland</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>
        A long-term evaluation of the impact of intensive diet and lifestyle intervention on coronary&#xD;
        plaque dynamics in patients with coronary atherosclerosis diagnosed in computed tomography&#xD;
        angiography (CCTA).&#xD;
  &#xD;
        92 patients who completed the Dietary Intervention to Stop COronart Atherosclerosis in&#xD;
        Computed Tomography study (DISCO-CT, NCT02571803) will be followed-up.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        All patients who completed the Dietary Intervention to Stop COronart Atherosclerosis in&#xD;
        Computed Tomography received dietary and lifestyle recommendations and were referred to&#xD;
        outpatient specialist care at their place of residence.&#xD;
  &#xD;
        As part of this study, patients will be invited for a follow-up visit consisting of a&#xD;
        cardiological and dietician consultation and additional tests, including CCTA, to assess the&#xD;
        long-term impact of the intervention on the progression of atherosclerotic plaques, including&#xD;
        high-risk plaque component.&#xD;
  &#xD;
        Additionally, the occurrence of cardiovascular events, change in laboratory parameters and&#xD;
        change in body weight composition will be analyzed.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Enrolling by invitation</overall_status>
    <start_date type="Actual">January 13, 2023</start_date>
    <completion_date type="Anticipated">March 31, 2024</completion_date>
    <primary_completion_date type="Anticipated">January 13, 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>Total Atheroma Volume (Change)</measure>
      <time_frame>60 months</time_frame>
      <description>Quantitative assessment of the coronary plaque dynamics will be analyzed in the coronary computed tomography angiography and compared with parameters measured at the completion of the DISCO-CT study (expressed in mm3)</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Percent Atheroma Volume (Change)</measure>
      <time_frame>60 months</time_frame>
      <description>Quantitative assessment of the coronary plaque dynamics will be analyzed in the coronary computed tomography angiography and compared with parameters measured at the completion of the DISCO-CT study (expressed in percent)&#xD;
  PAV = [(EEM-LA)/EEM]*100%&#xD;
  EEM - extrernal elastic membrane area LA - lumen area</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Calcified Plaque Volume (Change)</measure>
      <time_frame>60 months</time_frame>
      <description>Analyzed in the coronary computed tomography angiography and compared with parameters measured at the completion of the DISCO-CT study; calcified plaque volume (expressed in mm3) will be indentified according to plaque density in Hounsfield units, on a per-patient basis</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Fibrous Plaque Volume (Change)</measure>
      <time_frame>60 months</time_frame>
      <description>Analyzed in the coronary computed tomography angiography and compared with parameters measured at the completion of the DISCO-CT study; fibrous plaque volume (expressed in mm3) will be indentified according to plaque density in Hounsfield units, on a per-patient basis</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Fibrofatty Plaque Volume (Change)</measure>
      <time_frame>60 months</time_frame>
      <description>Analyzed in the coronary computed tomography angiography and compared with parameters measured at the completion of the DISCO-CT study; fibrofatty plaque volume (expressed in mm3) will be indentified according to plaque density in Hounsfield units, on a per-patient basis</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Necrotic Core (Low Density) Plaque Volume (Change)</measure>
      <time_frame>60 months</time_frame>
      <description>Analyzed in the coronary computed tomography angiography and compared with parameters measured at the completion of the DISCO-CT study; necrotic (low density) palque volume (expressed in mm3) will be indentified according to plaque density in Hounsfield units, on a per-patient basis</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Non-Calcified Plaque Volume (Change)</measure>
      <time_frame>60 months</time_frame>
      <description>Analyzed in the coronary computed tomography angiography and compared with parameters measured at the completion of the DISCO-CT study;&#xD;
  A combined component of fibrofatty + necrotic (low density) plaque (expressed in mm3), measured on a per-patient basis</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Rate of major cardiovascular events</measure>
      <time_frame>60 months</time_frame>
      <description>myocardial infarction&#xD;
  cardiovascular death&#xD;
  coronary revascularization</description>
    </secondary_outcome>
    <other_outcome>
      <measure>Change in body mass</measure>
      <time_frame>60 months</time_frame>
      <description>in kilograms</description>
    </other_outcome>
    <other_outcome>
      <measure>Change in total body fat</measure>
      <time_frame>60 months</time_frame>
      <description>expressed in kilograms</description>
    </other_outcome>
    <other_outcome>
      <measure>Change in skeletal muscle mass</measure>
      <time_frame>60 months</time_frame>
      <description>expressed in kilograms</description>
    </other_outcome>
    <other_outcome>
      <measure>Change in fat to muscle ratio</measure>
      <time_frame>60 months</time_frame>
      <description>expressed as the relation of fat mass to muscle mass</description>
    </other_outcome>
    <other_outcome>
      <measure>Change in epicardial fat volume</measure>
      <time_frame>60 months</time_frame>
      <description>semiautomated measurements based on the density in Hounsfield units performed in computed tomography angiography and expressed in cm3</description>
    </other_outcome>
    <other_outcome>
      <measure>Change in Visceral Fat Area</measure>
      <time_frame>60 months</time_frame>
      <description>Measured as part of body composition analysis, expressed in cm2</description>
    </other_outcome>
    <other_outcome>
      <measure>Change in total cholesterol</measure>
      <time_frame>60 months</time_frame>
      <description>mg/dL</description>
    </other_outcome>
    <other_outcome>
      <measure>Change in low density lipoprotein</measure>
      <time_frame>60 months</time_frame>
      <description>mg/dL</description>
    </other_outcome>
    <other_outcome>
      <measure>Change in the DASH Index</measure>
      <time_frame>60 months</time_frame>
      <description>adherence to the DASH plan in 8 main groups of foodstuffs (cerealproducts, vegetables, fruits, dairy products, meat,nuts/seeds, fats/oils, and sweets), with a maximumscore of 10 per group (total 0 to 80)</description>
    </other_outcome>
    <number_of_groups>2</number_of_groups>
    <enrollment type="Anticipated">92</enrollment>
    <condition>Coronary Artery Disease</condition>
    <condition>Diet, Healthy</condition>
    <condition>Lifestyle Risk Reduction</condition>
    <arm_group>
      <arm_group_label>DISCO Intervention</arm_group_label>
      <description>Patients included to the DISCO-CT study and randomized to the experimental arm, ie. subjected to optimal medical treatment in accordance with European Society of Cardiology recommendations + DASH diet (Dietary Approaches to StopHypertension) and strict monitoring of eating and lifestyle behaviors&#xD;
  n=46</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Control</arm_group_label>
      <description>Patients included to the DISCO-CT study and randomized to the control arm, ie. subjected to optimal medical treatment in accordance with European Society of Cardiology recommendations alone&#xD;
  n=46</description>
    </arm_group>
    <intervention>
      <intervention_type>Behavioral</intervention_type>
      <intervention_name>DISCO Intervention</intervention_name>
      <description>optimal medical management in accordance with European Society of Cardiology recommendations + dietary intervention based on Dietary Approaches to Stop Hypertension (DASH diet) + strict monitoring of eating and lifestyle behaviors</description>
      <arm_group_label>DISCO Intervention</arm_group_label>
    </intervention>
    <biospec_retention>Samples Without DNA</biospec_retention>
    <biospec_descr>
      <textblock>
        Plasma&#xD;
      </textblock>
    </biospec_descr>
    <eligibility>
      <study_pop>
        <textblock>
          The study population will be a group of participants of the DISCO-CT study (NCT02571803)&#xD;
          who will be willing to participate in the long-term follow-up at site.&#xD;
        </textblock>
      </study_pop>
      <sampling_method>Non-Probability Sample</sampling_method>
      <criteria>
        <textblock>
          Inclusion criteria:&#xD;
  &#xD;
            -  completion the DISCO-CT study (NCT02571803)&#xD;
  &#xD;
            -  willingness to participate in the long-term follow-up at site&#xD;
  &#xD;
          Exlusion criteria:&#xD;
  &#xD;
            -  contraindications to perform coronary computed tomography angiography (history of&#xD;
               severe reaction to iodine contrast media, uncontrolled thyreotoxicosis and/or severe&#xD;
               renal impairment with GFR &lt; 30 ml/min)&#xD;
  &#xD;
            -  no consent to participate&#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>Jan Henzel</last_name>
      <role>Principal Investigator</role>
      <affiliation>National Institute of Cardiology</affiliation>
    </overall_official>
    <location>
      <facility>
        <name>National Institute of Cardiology</name>
        <address>
          <city>Warszawa</city>
          <zip>04-628</zip>
          <country>Poland</country>
        </address>
      </facility>
    </location>
    <location_countries>
      <country>Poland</country>
    </location_countries>
    <reference>
      <citation>Henzel J, Kepka C, Kruk M, Makarewicz-Wujec M, Wardziak L, Trochimiuk P, Dzielinska Z, Demkow M. High-Risk Coronary Plaque Regression After Intensive Lifestyle Intervention in Nonobstructive Coronary Disease: A Randomized Study. JACC Cardiovasc Imaging. 2021 Jun;14(6):1192-1202. doi: 10.1016/j.jcmg.2020.10.019. Epub 2020 Dec 16.</citation>
      <PMID>33341413</PMID>
    </reference>
    <verification_date>April 2023</verification_date>
    <study_first_submitted>April 25, 2023</study_first_submitted>
    <study_first_submitted_qc>September 6, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">September 11, 2023</study_first_posted>
    <last_update_submitted>September 6, 2023</last_update_submitted>
    <last_update_submitted_qc>September 6, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 11, 2023</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>Coronary Artery Disease</mesh_term>
      <mesh_term>Myocardial Ischemia</mesh_term>
      <mesh_term>Atherosclerosis</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
    </patient_data>
    <!-- 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/NCT06031974
  org study id: 2.25/III/23
  nct id: NCT06031974
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  A long-term evaluation of the impact of intensive diet and lifestyle intervention on coronary
        plaque dynamics in patients with coronary atherosclerosis diagnosed in computed tomography
        angiography (CCTA).
  
        92 patients who completed the Dietary Intervention to Stop COronart Atherosclerosis in
        Computed Tomography study (DISCO-CT, NCT02571803) will be followed-up.
  All patients who completed the Dietary Intervention to Stop COronart Atherosclerosis in
        Computed Tomography received dietary and lifestyle recommendations and were referred to
        outpatient specialist care at their place of residence.
  
        As part of this study, patients will be invited for a follow-up visit consisting of a
        cardiological and dietician consultation and additional tests, including CCTA, to assess the
        long-term impact of the intervention on the progression of atherosclerotic plaques, including
        high-risk plaque component.
  
        Additionally, the occurrence of cardiovascular events, change in laboratory parameters and
        change in body weight composition will be analyzed.
  observational model: Cohort
  time perspective: Prospective
  measure: Total Atheroma Volume (Change)
  time frame: 60 months
  description: Quantitative assessment of the coronary plaque dynamics will be analyzed in the coronary computed tomography angiography and compared with parameters measured at the completion of the DISCO-CT study (expressed in mm3)
  measure: Percent Atheroma Volume (Change)
  time frame: 60 months
  description: Quantitative assessment of the coronary plaque dynamics will be analyzed in the coronary computed tomography angiography and compared with parameters measured at the completion of the DISCO-CT study (expressed in percent)
  PAV = [(EEM-LA)/EEM]*100%
  EEM - extrernal elastic membrane area LA - lumen area
  measure: Calcified Plaque Volume (Change)
  time frame: 60 months
  description: Analyzed in the coronary computed tomography angiography and compared with parameters measured at the completion of the DISCO-CT study; calcified plaque volume (expressed in mm3) will be indentified according to plaque density in Hounsfield units, on a per-patient basis
  measure: Fibrous Plaque Volume (Change)
  time frame: 60 months
  description: Analyzed in the coronary computed tomography angiography and compared with parameters measured at the completion of the DISCO-CT study; fibrous plaque volume (expressed in mm3) will be indentified according to plaque density in Hounsfield units, on a per-patient basis
  measure: Fibrofatty Plaque Volume (Change)
  time frame: 60 months
  description: Analyzed in the coronary computed tomography angiography and compared with parameters measured at the completion of the DISCO-CT study; fibrofatty plaque volume (expressed in mm3) will be indentified according to plaque density in Hounsfield units, on a per-patient basis
  measure: Necrotic Core (Low Density) Plaque Volume (Change)
  time frame: 60 months
  description: Analyzed in the coronary computed tomography angiography and compared with parameters measured at the completion of the DISCO-CT study; necrotic (low density) palque volume (expressed in mm3) will be indentified according to plaque density in Hounsfield units, on a per-patient basis
  measure: Non-Calcified Plaque Volume (Change)
  time frame: 60 months
  description: Analyzed in the coronary computed tomography angiography and compared with parameters measured at the completion of the DISCO-CT study;
  A combined component of fibrofatty + necrotic (low density) plaque (expressed in mm3), measured on a per-patient basis
  measure: Rate of major cardiovascular events
  time frame: 60 months
  description: myocardial infarction
  cardiovascular death
  coronary revascularization
  measure: Change in body mass
  time frame: 60 months
  description: in kilograms
  measure: Change in total body fat
  time frame: 60 months
  description: expressed in kilograms
  measure: Change in skeletal muscle mass
  time frame: 60 months
  description: expressed in kilograms
  measure: Change in fat to muscle ratio
  time frame: 60 months
  description: expressed as the relation of fat mass to muscle mass
  measure: Change in epicardial fat volume
  time frame: 60 months
  description: semiautomated measurements based on the density in Hounsfield units performed in computed tomography angiography and expressed in cm3
  measure: Change in Visceral Fat Area
  time frame: 60 months
  description: Measured as part of body composition analysis, expressed in cm2
  measure: Change in total cholesterol
  time frame: 60 months
  description: mg/dL
  measure: Change in low density lipoprotein
  time frame: 60 months
  description: mg/dL
  measure: Change in the DASH Index
  time frame: 60 months
  description: adherence to the DASH plan in 8 main groups of foodstuffs (cerealproducts, vegetables, fruits, dairy products, meat,nuts/seeds, fats/oils, and sweets), with a maximumscore of 10 per group (total 0 to 80)
  arm group label: DISCO Intervention
  description: Patients included to the DISCO-CT study and randomized to the experimental arm, ie. subjected to optimal medical treatment in accordance with European Society of Cardiology recommendations + DASH diet (Dietary Approaches to StopHypertension) and strict monitoring of eating and lifestyle behaviors
  n=46
  arm group label: Control
  description: Patients included to the DISCO-CT study and randomized to the control arm, ie. subjected to optimal medical treatment in accordance with European Society of Cardiology recommendations alone
  n=46
  intervention type: Behavioral
  intervention name: DISCO Intervention
  description: optimal medical management in accordance with European Society of Cardiology recommendations + dietary intervention based on Dietary Approaches to Stop Hypertension (DASH diet) + strict monitoring of eating and lifestyle behaviors
  arm group label: DISCO Intervention
  Plasma
  study pop: 
  sampling method: Non-Probability Sample
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: 90 Years
  healthy volunteers: No
  last name: Jan Henzel
  role: Principal Investigator
  affiliation: National Institute of Cardiology
  facility: 
  country: Poland
  citation: Henzel J, Kepka C, Kruk M, Makarewicz-Wujec M, Wardziak L, Trochimiuk P, Dzielinska Z, Demkow M. High-Risk Coronary Plaque Regression After Intensive Lifestyle Intervention in Nonobstructive Coronary Disease: A Randomized Study. JACC Cardiovasc Imaging. 2021 Jun;14(6):1192-1202. doi: 10.1016/j.jcmg.2020.10.019. Epub 2020 Dec 16.
  PMID: 33341413
  responsible party type: Sponsor
  mesh term: Coronary Artery Disease
  mesh term: Myocardial Ischemia
  mesh term: Atherosclerosis
  sharing ipd: No