<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/NCT03042117</url>
  </required_header>
  <id_info>
    <org_study_id>L17-008</org_study_id>
    <nct_id>NCT03042117</nct_id>
  </id_info>
  <brief_title>Connecting Periodontal and Coronary Artery Disease Via the Inflammatory State of the Body</brief_title>
  <official_title>Connecting Periodontal and Coronary Artery Disease Via the Inflammatory State of the Body</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Texas Tech University Health Sciences Center</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Texas Tech University Health Sciences Center</source>
  <brief_summary>
    <textblock>
      Cardiovascular disease is one of the leading causes of death in the United States and the&#xD;
      world. Many interventions relating to prevention have been emphasized as more risk factors&#xD;
      for this devastating disease are discovered. Periodontal disease is known to have a close&#xD;
      association with cardiovascular disease, but its role as a risk factor is still not well&#xD;
      understood. Inflammation is a driving force in both of these diseases, creating a potential&#xD;
      bridge between the two. Specifically, periodontal disease can cause an inflammatory reaction&#xD;
      in the body, which may predispose or even directly contribute to atheroma formation in the&#xD;
      coronary arteries. In this study, the investigators will study the link between the&#xD;
      inflammatory state of the body and will search for a correlation with levels of coronary&#xD;
      artery disease and periodontal disease. Inflammatory markers such as high-sensitivity&#xD;
      C-reactive protein (hs-CRP), erythrocyte sedimentation rate (ESR), and immunoglobulin G (IgG)&#xD;
      levels in the patient's blood will be analyzed and correlated to clinical attachment loss&#xD;
      measured via pocket depth measurement, the distance from the gingival margin to the base of&#xD;
      the pocket. A definitive link between these disease processes will allow preventive measures&#xD;
      to be taken earlier to prevent this lifelong disease.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Dental probes will be used to probe depth of gum recession in subjects with and without a&#xD;
      history of cardiac events. Venous blood samples will also be collected from all subjects for&#xD;
      measurement of sedimentation rate, myeloperoxidase, and IgG levels. Statistical analysis will&#xD;
      then be done, in attempt to identify a difference in gum recession depth and/or serum&#xD;
      inflammatory markers among those with and without prior cardiac events.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Withdrawn</overall_status>
  <why_stopped>
    Insufficient funds&#xD;
  </why_stopped>
  <start_date type="Actual">October 18, 2016</start_date>
  <completion_date type="Actual">July 13, 2017</completion_date>
  <primary_completion_date type="Actual">July 13, 2017</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Control</observational_model>
    <time_perspective>Cross-Sectional</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Level of periodontal disease</measure>
    <time_frame>one day</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>ESR</measure>
    <time_frame>one day</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Myeloperoxidase (MPO)</measure>
    <time_frame>one day</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>IgG</measure>
    <time_frame>one day</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>hs-CRP</measure>
    <time_frame>one day</time_frame>
  </secondary_outcome>
  <number_of_groups>3</number_of_groups>
  <enrollment type="Actual">0</enrollment>
  <condition>Periodontal Diseases</condition>
  <condition>Cardiovascular Diseases</condition>
  <arm_group>
    <arm_group_label>No Coronary Artery Disease (CAD)</arm_group_label>
    <description>Patients with no known cardiovascular disease.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>CAD without Myocardial Infarction (MI)</arm_group_label>
    <description>Patients with cardiovascular disease without a myocardial infarction.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>CAD with MI</arm_group_label>
    <description>Patients with cardiovascular disease with previous history of a myocardial infarction.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>periodontal probing</intervention_name>
    <description>A periodontal probe will be inserted between the tooth and the gum in the gingival sulcus and a measurement of the pocket depth will be measured by a trained dentist in all subjects</description>
    <arm_group_label>CAD with MI</arm_group_label>
    <arm_group_label>CAD without Myocardial Infarction (MI)</arm_group_label>
    <arm_group_label>No Coronary Artery Disease (CAD)</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        All patients from ages 18-89 years who are being seen in the Center for Cardiovascular&#xD;
        Health at TTUHSC and at Dr. Johnson's dental clinic who meet the inclusion criteria, and&#xD;
        who will consent to participating in the study. There will be between 25 to 35 patients in&#xD;
        each group.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Patients with known CAD with previous MI, OR&#xD;
&#xD;
          2. Patients without known CAD&#xD;
&#xD;
          3. Ages 18-89 years&#xD;
&#xD;
          4. Patients who have dental implants with a recorded patient history of how the teeth&#xD;
             were lost&#xD;
&#xD;
          5. Patients with at least one tooth in each of the four quadrants of the mouth&#xD;
&#xD;
          6. Able to obtain all necessary pocket measurements and blood samples needed for the&#xD;
             study&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Patients with a known history of rheumatoid arthritis&#xD;
&#xD;
          2. Patients with a known history of lupus&#xD;
&#xD;
          3. Patients currently under the care of a rheumatologist&#xD;
&#xD;
          4. Patients who have had a MI in the two weeks prior to entering the study&#xD;
&#xD;
          5. Patients with a previous history of coronary artery bypass graft&#xD;
&#xD;
          6. Current smokers and tobacco users&#xD;
&#xD;
          7. Patients on disease-modifying agents for rheumatoid arthritis (methotrexate)10.&#xD;
             Patients who have undergone chemotherapy in the past five years&#xD;
&#xD;
          8. Patients who currently use steroids or immunosuppressive agents&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>89 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Ami Knox, MBA</last_name>
    <role>Study Director</role>
    <affiliation>Texas Tech University Health Sciences Center</affiliation>
  </overall_official>
  <verification_date>January 2020</verification_date>
  <study_first_submitted>January 26, 2017</study_first_submitted>
  <study_first_submitted_qc>February 1, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">February 3, 2017</study_first_posted>
  <last_update_submitted>January 28, 2020</last_update_submitted>
  <last_update_submitted_qc>January 28, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">January 30, 2020</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>Periodontal Diseases</mesh_term>
    <mesh_term>Cardiovascular Diseases</mesh_term>
    <mesh_term>Coronary Artery Disease</mesh_term>
    <mesh_term>Myocardial Ischemia</mesh_term>
    <mesh_term>Coronary Disease</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
    <ipd_description>Data will not be shared with other researchers</ipd_description>
  </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/NCT03042117
org study id: L17-008
nct id: NCT03042117
lead sponsor: 
Cardiovascular disease is one of the leading causes of death in the United States and the
      world. Many interventions relating to prevention have been emphasized as more risk factors
      for this devastating disease are discovered. Periodontal disease is known to have a close
      association with cardiovascular disease, but its role as a risk factor is still not well
      understood. Inflammation is a driving force in both of these diseases, creating a potential
      bridge between the two. Specifically, periodontal disease can cause an inflammatory reaction
      in the body, which may predispose or even directly contribute to atheroma formation in the
      coronary arteries. In this study, the investigators will study the link between the
      inflammatory state of the body and will search for a correlation with levels of coronary
      artery disease and periodontal disease. Inflammatory markers such as high-sensitivity
      C-reactive protein (hs-CRP), erythrocyte sedimentation rate (ESR), and immunoglobulin G (IgG)
      levels in the patient's blood will be analyzed and correlated to clinical attachment loss
      measured via pocket depth measurement, the distance from the gingival margin to the base of
      the pocket. A definitive link between these disease processes will allow preventive measures
      to be taken earlier to prevent this lifelong disease.
Dental probes will be used to probe depth of gum recession in subjects with and without a
      history of cardiac events. Venous blood samples will also be collected from all subjects for
      measurement of sedimentation rate, myeloperoxidase, and IgG levels. Statistical analysis will
      then be done, in attempt to identify a difference in gum recession depth and/or serum
      inflammatory markers among those with and without prior cardiac events.
observational model: Case-Control
time perspective: Cross-Sectional
measure: Level of periodontal disease
time frame: one day
measure: ESR
time frame: one day
measure: Myeloperoxidase (MPO)
time frame: one day
measure: IgG
time frame: one day
measure: hs-CRP
time frame: one day
arm group label: No Coronary Artery Disease (CAD)
description: Patients with no known cardiovascular disease.
arm group label: CAD without Myocardial Infarction (MI)
description: Patients with cardiovascular disease without a myocardial infarction.
arm group label: CAD with MI
description: Patients with cardiovascular disease with previous history of a myocardial infarction.
intervention type: Other
intervention name: periodontal probing
description: A periodontal probe will be inserted between the tooth and the gum in the gingival sulcus and a measurement of the pocket depth will be measured by a trained dentist in all subjects
arm group label: CAD with MI
arm group label: CAD without Myocardial Infarction (MI)
arm group label: No Coronary Artery Disease (CAD)
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: 89 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Ami Knox, MBA
role: Study Director
affiliation: Texas Tech University Health Sciences Center
responsible party type: Sponsor
mesh term: Periodontal Diseases
mesh term: Cardiovascular Diseases
mesh term: Coronary Artery Disease
mesh term: Myocardial Ischemia
mesh term: Coronary Disease
sharing ipd: No
ipd description: Data will not be shared with other researchers