<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/NCT02191306</url>
  </required_header>
  <id_info>
    <org_study_id>IRB00000446</org_study_id>
    <nct_id>NCT02191306</nct_id>
  </id_info>
  <brief_title>Utilizing Computed Tomographic Angiography to Evaluate Coronary Artery Disease in Patients on Long-Term Antiretroviral Therapy</brief_title>
  <sponsors>
    <lead_sponsor>
      <agency>Florida State University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Florida State University</source>
  <brief_summary>
    <textblock>
      Utilizing Computed Tomographic Angiography to Evaluate Coronary Artery Disease in Patients on&#xD;
      Long-Term Antiretroviral Therapy&#xD;
&#xD;
      Intro:&#xD;
&#xD;
      It is well known that HIV treated with antiretroviral drugs increases the risk for coronary&#xD;
      artery disease. Studies have documented this with various methods including analyzing the&#xD;
      effects of retroviral therapy on cardiac risk factors such as diabetes, lipids and&#xD;
      hypertension. Still other studies have looked at carotid and brachial artery intimal&#xD;
      thickness. Our study, then, aims to evaluate the relationship between HIV medications and&#xD;
      coronary atherosclerosis using a novel method. Coronary artery CT angiography is a relatively&#xD;
      new diagnostic procedure to evaluate heart disease in cardiac patients. We will apply this&#xD;
      test to HIV patients on longstanding antiretroviral therapy to directly examine their&#xD;
      coronary arteries to assess heart disease.&#xD;
&#xD;
      Hypothesis:&#xD;
&#xD;
      We hypothesize that HIV patients on antiretroviral therapy will have increased coronary&#xD;
      artery disease compared to the general population.&#xD;
&#xD;
      Methods:&#xD;
&#xD;
      This project will be conducted in collaboration between Florida Heart Center and Associates&#xD;
      in infectious Disease - two communities based infectious disease and cardiology practices. We&#xD;
      will identify all the HIV positive patients seen within a 1 month timeframe at the infectious&#xD;
      disease office. These patients will then be filtered by our exclusion/inclusion criteria.&#xD;
      After obtaining informed consent, we will draw blood from each patient to gather lab values&#xD;
      such as A1C, cholesterol, inflammatory markers, and other markers associated with coronary&#xD;
      artery disease. Each enrolled patient will then schedule and receive a 64 slide coronary CTA&#xD;
      at Florida Heart Center. The results of the CTA scans will be categorized in mild, moderate,&#xD;
      and severe coronary artery disease. The data, then, will consist of the parameters measured&#xD;
      on blood work, and the results of the coronary CTA.&#xD;
&#xD;
      Inclusion Criteria:&#xD;
&#xD;
      1. Patients aged 35 to 50 with HIV and on retroviral therapy for at least 5 years.&#xD;
&#xD;
      Exclusion Criteria:&#xD;
&#xD;
      1. Patients with prior documented coronary artery disease, heart attack, stent placement, or&#xD;
      heart surgery.&#xD;
&#xD;
      Statistical Analysis:&#xD;
&#xD;
      We will conduct a multivariate analysis on the cardiac risk factors taken from patient&#xD;
      history and the bloodwork (diabetes, lipids etc) to correlate them with the results of the&#xD;
      CTA. We will also conduct basic analysis to support our hypothesis that long term&#xD;
      antiretroviral therapy increases coronary artery disease.&#xD;
&#xD;
      Funding:&#xD;
&#xD;
      The bloodwork and CTA tests ordered in this study will be payed for by insurance companies&#xD;
      where available. In cases where insurance companies will not pay, Florida Heart Center will&#xD;
      pay for the CTA tests and Associates in infectious Disease will fund the bloodwork.&#xD;
&#xD;
      Humans Subjects Protection:&#xD;
&#xD;
      This will be a projective chart review study that will require access to protected health&#xD;
      information. Thus, we will seek full IRB approval from the FSU IRB committee with informed&#xD;
      consent. An informed consent document will be given to each patient explaining all the risks&#xD;
      and benefits of the study in addition to the methods. Recruitment will be done by an office&#xD;
      staff or medical assistant not on the research team. After patient recruitment, their medical&#xD;
      records will be flagged for study and they will undergo the required testing. At completion&#xD;
      of testing, their results will be recorded in the final data sheet, and their medical record&#xD;
      will no longer be flagged for study. No identifying data will be recorded in the final data&#xD;
      sheet, and the data will be stored in an encrypted excel sheet on a secure password protected&#xD;
      personal laptop running antivirus and firewall. Third parties (such as family members) will&#xD;
      not have access to any research data regardless of authorizations received from the study&#xD;
      subjects. All the test results and labwork performed for the study will go into the patient's&#xD;
      individual medical record at their respective offices. Thus, if an authorized third party&#xD;
      wishes to view any test results, they can do so via the normal methods at the doctor's&#xD;
      office.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">October 2013</start_date>
  <completion_date type="Actual">March 2014</completion_date>
  <primary_completion_date type="Actual">March 2014</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>1 Week</target_duration>
  <primary_outcome>
    <measure>Calcium Score Measured from CT Angiography</measure>
    <time_frame>1 Day</time_frame>
    <description>Each CT Scan was analyzed and a calcium score was associate with each plaque lesion in the coronary arteries. This score correlates with the presence of coronary artery disease in the patient.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Increased Inflammatory Markers in Bloodwork</measure>
    <time_frame>1 Day</time_frame>
    <description>The blood work taken from each HIV positive patient was run with a cardiovascular inflammatory marker panel which gave the researchers another measure of coronary artery disease</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Increased Inflammatory Markers on Lab Panel</measure>
    <time_frame>1 Day</time_frame>
    <description>The blood work taken from each HIV positive patient was run with a cardiovascular inflammatory marker panel which gave the researchers another measure of coronary artery disease</description>
  </secondary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Actual">78</enrollment>
  <condition>Evaluate the Relationship Between HIV Medications and Coronary Atherosclerosis</condition>
  <arm_group>
    <arm_group_label>HIV Positive Patients (Study Group)</arm_group_label>
  </arm_group>
  <arm_group>
    <arm_group_label>Non HIV Positive Patients (Control)</arm_group_label>
  </arm_group>
  <eligibility>
    <study_pop>
      <textblock>
        Patients aged 35 to 50 with HIV and on antiretroviral therapy for at least 5 years. These&#xD;
        patients also cannot have any documented history of coronary artery disease or cardiac&#xD;
        interventions.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients aged 35 to 50 with HIV and on retroviral therapy for at least 5 years&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients with prior documented coronary artery disease, heart attack, stent placement,&#xD;
             or heart surgery.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>35 Years</minimum_age>
    <maximum_age>50 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Associates in Infectious Disease</name>
      <address>
        <city>Fort Pierce</city>
        <state>Florida</state>
        <zip>34950</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Florida Heart Center</name>
      <address>
        <city>Fort Pierce</city>
        <state>Florida</state>
        <zip>34950</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <link>
    <url>http://www.hopkinsmedicine.org/news/media/releases/johns_hopkins_study_shows_link_between_hiv_infection_and_coronary_artery_disease</url>
    <description>Related Info</description>
  </link>
  <link>
    <url>http://www.uptodate.com/contents/cardiac-and-vascular-disease-in-hiv-infected-patients</url>
    <description>Related Info</description>
  </link>
  <reference>
    <citation>Lo J, Abbara S, Shturman L, Soni A, Wei J, Rocha-Filho JA, Nasir K, Grinspoon SK. Increased prevalence of subclinical coronary atherosclerosis detected by coronary computed tomography angiography in HIV-infected men. AIDS. 2010 Jan 16;24(2):243-53. doi: 10.1097/QAD.0b013e328333ea9e.</citation>
    <PMID>19996940</PMID>
  </reference>
  <reference>
    <citation>Ross AC, Rizk N, O'Riordan MA, Dogra V, El-Bejjani D, Storer N, Harrill D, Tungsiripat M, Adell J, McComsey GA. Relationship between inflammatory markers, endothelial activation markers, and carotid intima-media thickness in HIV-infected patients receiving antiretroviral therapy. Clin Infect Dis. 2009 Oct 1;49(7):1119-27. doi: 10.1086/605578.</citation>
    <PMID>19712036</PMID>
  </reference>
  <reference>
    <citation>Fitch KV, Srinivasa S, Abbara S, Burdo TH, Williams KC, Eneh P, Lo J, Grinspoon SK. Noncalcified coronary atherosclerotic plaque and immune activation in HIV-infected women. J Infect Dis. 2013 Dec 1;208(11):1737-46. doi: 10.1093/infdis/jit508. Epub 2013 Sep 16.</citation>
    <PMID>24041790</PMID>
  </reference>
  <verification_date>April 2022</verification_date>
  <study_first_submitted>July 14, 2014</study_first_submitted>
  <study_first_submitted_qc>July 14, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">July 16, 2014</study_first_posted>
  <last_update_submitted>April 19, 2022</last_update_submitted>
  <last_update_submitted_qc>April 19, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">April 26, 2022</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>Atherosclerosis</mesh_term>
    <mesh_term>Coronary Artery Disease</mesh_term>
    <mesh_term>Myocardial Ischemia</mesh_term>
  </condition_browse>
  <!-- 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/NCT02191306
org study id: IRB00000446
nct id: NCT02191306
lead sponsor: 
Utilizing Computed Tomographic Angiography to Evaluate Coronary Artery Disease in Patients on
      Long-Term Antiretroviral Therapy

      Intro:

      It is well known that HIV treated with antiretroviral drugs increases the risk for coronary
      artery disease. Studies have documented this with various methods including analyzing the
      effects of retroviral therapy on cardiac risk factors such as diabetes, lipids and
      hypertension. Still other studies have looked at carotid and brachial artery intimal
      thickness. Our study, then, aims to evaluate the relationship between HIV medications and
      coronary atherosclerosis using a novel method. Coronary artery CT angiography is a relatively
      new diagnostic procedure to evaluate heart disease in cardiac patients. We will apply this
      test to HIV patients on longstanding antiretroviral therapy to directly examine their
      coronary arteries to assess heart disease.

      Hypothesis:

      We hypothesize that HIV patients on antiretroviral therapy will have increased coronary
      artery disease compared to the general population.

      Methods:

      This project will be conducted in collaboration between Florida Heart Center and Associates
      in infectious Disease - two communities based infectious disease and cardiology practices. We
      will identify all the HIV positive patients seen within a 1 month timeframe at the infectious
      disease office. These patients will then be filtered by our exclusion/inclusion criteria.
      After obtaining informed consent, we will draw blood from each patient to gather lab values
      such as A1C, cholesterol, inflammatory markers, and other markers associated with coronary
      artery disease. Each enrolled patient will then schedule and receive a 64 slide coronary CTA
      at Florida Heart Center. The results of the CTA scans will be categorized in mild, moderate,
      and severe coronary artery disease. The data, then, will consist of the parameters measured
      on blood work, and the results of the coronary CTA.

      Inclusion Criteria:

      1. Patients aged 35 to 50 with HIV and on retroviral therapy for at least 5 years.

      Exclusion Criteria:

      1. Patients with prior documented coronary artery disease, heart attack, stent placement, or
      heart surgery.

      Statistical Analysis:

      We will conduct a multivariate analysis on the cardiac risk factors taken from patient
      history and the bloodwork (diabetes, lipids etc) to correlate them with the results of the
      CTA. We will also conduct basic analysis to support our hypothesis that long term
      antiretroviral therapy increases coronary artery disease.

      Funding:

      The bloodwork and CTA tests ordered in this study will be payed for by insurance companies
      where available. In cases where insurance companies will not pay, Florida Heart Center will
      pay for the CTA tests and Associates in infectious Disease will fund the bloodwork.

      Humans Subjects Protection:

      This will be a projective chart review study that will require access to protected health
      information. Thus, we will seek full IRB approval from the FSU IRB committee with informed
      consent. An informed consent document will be given to each patient explaining all the risks
      and benefits of the study in addition to the methods. Recruitment will be done by an office
      staff or medical assistant not on the research team. After patient recruitment, their medical
      records will be flagged for study and they will undergo the required testing. At completion
      of testing, their results will be recorded in the final data sheet, and their medical record
      will no longer be flagged for study. No identifying data will be recorded in the final data
      sheet, and the data will be stored in an encrypted excel sheet on a secure password protected
      personal laptop running antivirus and firewall. Third parties (such as family members) will
      not have access to any research data regardless of authorizations received from the study
      subjects. All the test results and labwork performed for the study will go into the patient's
      individual medical record at their respective offices. Thus, if an authorized third party
      wishes to view any test results, they can do so via the normal methods at the doctor's
      office.
observational model: Cohort
time perspective: Prospective
measure: Calcium Score Measured from CT Angiography
time frame: 1 Day
description: Each CT Scan was analyzed and a calcium score was associate with each plaque lesion in the coronary arteries. This score correlates with the presence of coronary artery disease in the patient.
measure: Increased Inflammatory Markers in Bloodwork
time frame: 1 Day
description: The blood work taken from each HIV positive patient was run with a cardiovascular inflammatory marker panel which gave the researchers another measure of coronary artery disease
measure: Increased Inflammatory Markers on Lab Panel
time frame: 1 Day
description: The blood work taken from each HIV positive patient was run with a cardiovascular inflammatory marker panel which gave the researchers another measure of coronary artery disease
arm group label: HIV Positive Patients (Study Group)
arm group label: Non HIV Positive Patients (Control)
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 35 Years
maximum age: 50 Years
healthy volunteers: Accepts Healthy Volunteers
facility: 
facility: 
country: United States
url: http://www.hopkinsmedicine.org/news/media/releases/johns_hopkins_study_shows_link_between_hiv_infection_and_coronary_artery_disease
description: Related Info
url: http://www.uptodate.com/contents/cardiac-and-vascular-disease-in-hiv-infected-patients
description: Related Info
citation: Lo J, Abbara S, Shturman L, Soni A, Wei J, Rocha-Filho JA, Nasir K, Grinspoon SK. Increased prevalence of subclinical coronary atherosclerosis detected by coronary computed tomography angiography in HIV-infected men. AIDS. 2010 Jan 16;24(2):243-53. doi: 10.1097/QAD.0b013e328333ea9e.
PMID: 19996940
citation: Ross AC, Rizk N, O'Riordan MA, Dogra V, El-Bejjani D, Storer N, Harrill D, Tungsiripat M, Adell J, McComsey GA. Relationship between inflammatory markers, endothelial activation markers, and carotid intima-media thickness in HIV-infected patients receiving antiretroviral therapy. Clin Infect Dis. 2009 Oct 1;49(7):1119-27. doi: 10.1086/605578.
PMID: 19712036
citation: Fitch KV, Srinivasa S, Abbara S, Burdo TH, Williams KC, Eneh P, Lo J, Grinspoon SK. Noncalcified coronary atherosclerotic plaque and immune activation in HIV-infected women. J Infect Dis. 2013 Dec 1;208(11):1737-46. doi: 10.1093/infdis/jit508. Epub 2013 Sep 16.
PMID: 24041790
responsible party type: Sponsor
mesh term: Atherosclerosis
mesh term: Coronary Artery Disease
mesh term: Myocardial Ischemia