<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/NCT04462159</url>
  </required_header>
  <id_info>
    <org_study_id>20-0073</org_study_id>
    <nct_id>NCT04462159</nct_id>
  </id_info>
  <brief_title>The Young Heart Study</brief_title>
  <official_title>Young Patients With Coronary Heart Disease Trial- Assessment of Risk Factors and the Impact of a Risk Reduction Program</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Northwell Health</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Northwell Health</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 purpose of our project is to better understand the characteristics of the young patients&#xD;
      with coronary artery disease presenting for cardiac catheterization at our institution and to&#xD;
      put forth a program to optimize their risk factors with a focus on gender differences. We&#xD;
      will assess traditional and non-traditional risk factors, as well as genetics and&#xD;
      environment. These characteristics will be compared by gender to determine unique factors&#xD;
      related to women that could subsequently be targeted. The program will begin with universal&#xD;
      education about the process of atherosclerosis, risk factors contributing to the disease and&#xD;
      specific risk factor goals for each patient for the 6 month program. The patients will then&#xD;
      be part of a bimonthly 6 month cardiovascular risk reduction program that will offer both a&#xD;
      nutritional program with teaching kitchen component, and exercise instruction lead by an&#xD;
      exercise physiologist. Psychological support will be provided to address stress that impairs&#xD;
      quality of life, depression or anxiety to fully optimize the lifestyle component. These&#xD;
      sessions will be done virtually in order to comply with social distancing until in person&#xD;
      sessions can resume.&#xD;
&#xD;
      The investigational endpoints of this program will include a variety of CVD risk factors,&#xD;
      biomarkers, lifestyle behaviors, quality of life and guideline-based medical regimen. At the&#xD;
      end of this phase, we aim to both better understand differences in risk factors and the&#xD;
      interventions with the biggest impact in terms of risk factor optimization in men vs. women.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Active, not recruiting</overall_status>
  <start_date type="Actual">May 27, 2020</start_date>
  <completion_date type="Anticipated">May 27, 2026</completion_date>
  <primary_completion_date type="Actual">March 28, 2022</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Other</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change in CV Risk Factor - Cholesterol levels</measure>
    <time_frame>6 months</time_frame>
    <description>Will assess changes pre and post intervention in Low Density Lipoprotein Cholesterol level (measured in mg/dL)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in CV Risk Factor - Blood pressure</measure>
    <time_frame>6 months</time_frame>
    <description>Will assess changes pre and post intervention in blood pressure (mmHg)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in CV Risk Factor - Glucometabolic state (A1C)</measure>
    <time_frame>6 months</time_frame>
    <description>Will assess changes pre and post intervention in glycemic control measured by the hemoglobin A1C (%)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in CV Risk Factor - Smoking Status</measure>
    <time_frame>6 months</time_frame>
    <description>Will assess changes pre and post intervention in smoking status (including quantity of cigarettes)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in CV Risk Factor - Physical activity/inactivity</measure>
    <time_frame>6 months</time_frame>
    <description>Will assess changes pre and post intervention in physical activity which will be done through a questionnaire where participants will report the frequency and intensity of exercise</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in CV Risk Factor - Overweight/Obesity</measure>
    <time_frame>6 months</time_frame>
    <description>Will assess changes in weight by weighing patients on initial visit and again at follow-up. This value will be used in combination with patient's height to evaluate changes in body mass index.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in CV Risk Factors - Diet</measure>
    <time_frame>6 months</time_frame>
    <description>Will assess changes pre and post intervention in diet which will be done via a food intake questionnaire</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in CV Risk Factors - TMAO levels</measure>
    <time_frame>6 months</time_frame>
    <description>Will assess changes pre and post intervention in trimethylamine N-oxide (TMAO) levels (microM)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in CV Risk Factors - hs-CRP levels</measure>
    <time_frame>6 months</time_frame>
    <description>Will assess changes pre and post intervention in high sensitive C-reactive protein measured in mg/L</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in Quality of Life Score</measure>
    <time_frame>6 months</time_frame>
    <description>Surveys of Quality of Life and emotional well-being will be given at baseline and again at the end of the program</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Number of Cardiovascular events</measure>
    <time_frame>5 years</time_frame>
    <description>Cardiovascular events assessed by a yearly phone call to the patient for up to 5 yrs</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">60</enrollment>
  <condition>Atherosclerotic Cardiovascular Disease</condition>
  <condition>Coronary Artery Disease</condition>
  <arm_group>
    <arm_group_label>Risk Reduction Program</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>All participants will receive education about the process of atherosclerosis, risk factors contributing to the disease and specific risk factor goals for each patient for the 6 month program. The patients will then be part of a bimonthly 6 month cardiovascular risk reduction program that will offer both a nutritional program with teaching kitchen component, and exercise instruction lead by an exercise physiologist. Psychological support will be provided to address stress that impairs quality of life, depression or anxiety to fully optimize the lifestyle component.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Risk Reduction Program</intervention_name>
    <description>Education, exercise, teaching kitchen and nutrition, and psychological support</description>
    <arm_group_label>Risk Reduction Program</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patient with atherosclerotic cardiovascular disease&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Age 55 years or older&#xD;
&#xD;
          -  Physical limitation that will prevent them from being part of the exercise part of the&#xD;
             study&#xD;
&#xD;
          -  Given that all the sessions will be given in English, participants not fluent in&#xD;
             English will be excluded&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>55 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Eugenia Gianos, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Northwell Health</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Lenox Hill Hospital</name>
      <address>
        <city>New York</city>
        <state>New York</state>
        <zip>10075</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>October 2022</verification_date>
  <study_first_submitted>February 20, 2020</study_first_submitted>
  <study_first_submitted_qc>July 4, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 8, 2020</study_first_posted>
  <last_update_submitted>October 25, 2022</last_update_submitted>
  <last_update_submitted_qc>October 25, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">October 27, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Northwell Health</investigator_affiliation>
    <investigator_full_name>Eugenia Gianos</investigator_full_name>
    <investigator_title>Director- Cardiovascular Prevention, Associate Professor</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Cardiovascular Diseases</mesh_term>
    <mesh_term>Coronary Artery Disease</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>


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/NCT04462159
org study id: 20-0073
nct id: NCT04462159
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The purpose of our project is to better understand the characteristics of the young patients
      with coronary artery disease presenting for cardiac catheterization at our institution and to
      put forth a program to optimize their risk factors with a focus on gender differences. We
      will assess traditional and non-traditional risk factors, as well as genetics and
      environment. These characteristics will be compared by gender to determine unique factors
      related to women that could subsequently be targeted. The program will begin with universal
      education about the process of atherosclerosis, risk factors contributing to the disease and
      specific risk factor goals for each patient for the 6 month program. The patients will then
      be part of a bimonthly 6 month cardiovascular risk reduction program that will offer both a
      nutritional program with teaching kitchen component, and exercise instruction lead by an
      exercise physiologist. Psychological support will be provided to address stress that impairs
      quality of life, depression or anxiety to fully optimize the lifestyle component. These
      sessions will be done virtually in order to comply with social distancing until in person
      sessions can resume.

      The investigational endpoints of this program will include a variety of CVD risk factors,
      biomarkers, lifestyle behaviors, quality of life and guideline-based medical regimen. At the
      end of this phase, we aim to both better understand differences in risk factors and the
      interventions with the biggest impact in terms of risk factor optimization in men vs. women.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Other
masking: None (Open Label)
measure: Change in CV Risk Factor - Cholesterol levels
time frame: 6 months
description: Will assess changes pre and post intervention in Low Density Lipoprotein Cholesterol level (measured in mg/dL)
measure: Change in CV Risk Factor - Blood pressure
time frame: 6 months
description: Will assess changes pre and post intervention in blood pressure (mmHg)
measure: Change in CV Risk Factor - Glucometabolic state (A1C)
time frame: 6 months
description: Will assess changes pre and post intervention in glycemic control measured by the hemoglobin A1C (%)
measure: Change in CV Risk Factor - Smoking Status
time frame: 6 months
description: Will assess changes pre and post intervention in smoking status (including quantity of cigarettes)
measure: Change in CV Risk Factor - Physical activity/inactivity
time frame: 6 months
description: Will assess changes pre and post intervention in physical activity which will be done through a questionnaire where participants will report the frequency and intensity of exercise
measure: Change in CV Risk Factor - Overweight/Obesity
time frame: 6 months
description: Will assess changes in weight by weighing patients on initial visit and again at follow-up. This value will be used in combination with patient's height to evaluate changes in body mass index.
measure: Change in CV Risk Factors - Diet
time frame: 6 months
description: Will assess changes pre and post intervention in diet which will be done via a food intake questionnaire
measure: Change in CV Risk Factors - TMAO levels
time frame: 6 months
description: Will assess changes pre and post intervention in trimethylamine N-oxide (TMAO) levels (microM)
measure: Change in CV Risk Factors - hs-CRP levels
time frame: 6 months
description: Will assess changes pre and post intervention in high sensitive C-reactive protein measured in mg/L
measure: Change in Quality of Life Score
time frame: 6 months
description: Surveys of Quality of Life and emotional well-being will be given at baseline and again at the end of the program
measure: Number of Cardiovascular events
time frame: 5 years
description: Cardiovascular events assessed by a yearly phone call to the patient for up to 5 yrs
arm group label: Risk Reduction Program
arm group type: Experimental
description: All participants will receive education about the process of atherosclerosis, risk factors contributing to the disease and specific risk factor goals for each patient for the 6 month program. The patients will then be part of a bimonthly 6 month cardiovascular risk reduction program that will offer both a nutritional program with teaching kitchen component, and exercise instruction lead by an exercise physiologist. Psychological support will be provided to address stress that impairs quality of life, depression or anxiety to fully optimize the lifestyle component.
intervention type: Behavioral
intervention name: Risk Reduction Program
description: Education, exercise, teaching kitchen and nutrition, and psychological support
arm group label: Risk Reduction Program
criteria: 
gender: All
minimum age: 18 Years
maximum age: 55 Years
healthy volunteers: No
last name: Eugenia Gianos, MD
role: Principal Investigator
affiliation: Northwell Health
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: Northwell Health
investigator full name: Eugenia Gianos
investigator title: Director- Cardiovascular Prevention, Associate Professor
mesh term: Cardiovascular Diseases
mesh term: Coronary Artery Disease
mesh term: Atherosclerosis
sharing ipd: No