<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/NCT02246101</url>
  </required_header>
  <id_info>
    <org_study_id>GCO 13-1847</org_study_id>
    <secondary_id>1U01OH010716-01</secondary_id>
    <nct_id>NCT02246101</nct_id>
  </id_info>
  <brief_title>World Trade Center (WTC) RENAL</brief_title>
  <official_title>Renal and Cardiovascular Impairment in WTC Responders: Implications for Diagnosis and Treatment</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Icahn School of Medicine at Mount Sinai</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>National Institute for Occupational Safety and Health (NIOSH/CDC)</agency>
      <agency_class>U.S. Fed</agency_class>
    </collaborator>
  </sponsors>
  <source>Icahn School of Medicine at Mount Sinai</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Environmental toxins exert damaging health effects in workers. Thousands of responders who&#xD;
      worked or volunteered on the World Trade Center (WTC) rescue and recovery effort following&#xD;
      the September 11, 2001 attacks suffer from health conditions or may be at increased risk for&#xD;
      worsening health. In a pilot study, investigators identified the first evidence of kidney&#xD;
      damage in subjects with very high exposure at Ground Zero. Specifically, noted was a&#xD;
      preliminary association between the intensity of particulate matter exposure and albuminuria,&#xD;
      a marker of early chronic kidney disease (CKD), systemic endothelial dysfunction, and&#xD;
      increased cardiovascular risk.&#xD;
&#xD;
      The long-term goal is to minimize the risk of CKD and cardiovascular disease (CVD) among&#xD;
      individuals exposed to inhaled toxins. The primary objective of this research is to quantify&#xD;
      the risk of kidney damage among first responders to the WTC attack and to determine the&#xD;
      relationship to particulate matter exposure as well as determine an association between renal&#xD;
      and cardiovascular damage in first responders and to explore potential mechanisms. The&#xD;
      central hypothesis is that exposure to inhaled particulate matter causes systemic&#xD;
      inflammation and endothelial dysfunction that result in chronic kidney and cardiovascular&#xD;
      damage. This hypothesis will be investigated in a subgroup of participants from a previously&#xD;
      conducted NIOSH-funded study &quot;Pulmonary Function Abnormalities, Diastolic Dysfunction and WTC&#xD;
      Exposure: Implications for Diagnosis and Treatment&quot; (&quot;WTC-CHEST,&quot; PI Mary Ann McLaughlin).&#xD;
&#xD;
      The proposed study will capitalize on unique resources in WTC-CHEST, including the&#xD;
      standardized collection of data on particulate matter exposure and shared risk factors for&#xD;
      CKD and cardiovascular disease, and cardiopulmonary function testing. The output from this&#xD;
      proposal is anticipated to have a broad impact on understanding the health effects of inhaled&#xD;
      particulate matter.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Specific Aim 1. To quantify the risk of kidney damage and the relationship to particulate&#xD;
      matter exposure among first responders to the WTC attack.&#xD;
&#xD;
      Urine samples will be collected on 2 occasions for albumin and creatinine. The investigators&#xD;
      will define clinically relevant albuminuria as a UACR ≥30 mg/g. If, as hypothesized, the&#xD;
      investigators find that albuminuria is more common among WTC responders, this simple and&#xD;
      non-invasive measure may be useful in monitoring programs to identify responders at increased&#xD;
      risk for adverse outcomes. eGFR will be calculated using the Chronic Kidney Disease&#xD;
      Epidemiology Consortium (CKD-EPI) equations.&#xD;
&#xD;
      Specific Aim 2. To examine the relationship between kidney damage and cardiac structure and&#xD;
      function among first responders to the WTC attack.&#xD;
&#xD;
      Cardiovascular Disease Risk Screening In order to identify an independent relationship&#xD;
      between CKD and cardiac dysfunction, the investigators will comprehensively evaluate&#xD;
      potential confounders. Participants will undergo an evaluation of traditional CVD risk&#xD;
      factors as accounted for in both the Framingham Risk Score and Reynold's score (medical&#xD;
      history, medication use and baseline risk for CVD: smoking status, family history of&#xD;
      premature coronary disease, blood pressure, heart rate, height, weight, waist, hip and neck&#xD;
      circumference). Laboratory evaluation will include: lipid panel, complete blood count, HbA1C,&#xD;
      serum creatinine and cystatin C. Standard questionnaires on chest pain, shortness of breath,&#xD;
      depression, sleep apnea and stress, IPSS.&#xD;
&#xD;
      Specific Aim 3. To explore potential mechanisms for kidney and cardiovascular damage among&#xD;
      first responders to the WTC attack.&#xD;
&#xD;
      An established marker of systemic inflammation, serum hsCRP, will be measured in all&#xD;
      participants. Flow-mediated dilatation, a validated non-invasive measure of endothelial&#xD;
      function, will be measured in a subgroup of participants. Heavy metal assays will be&#xD;
      performed and will be compared between participants with and without evidence of kidney&#xD;
      damage (albuminuria or decreased eGFR) or proximal tubular dysfunction.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>July 2014</start_date>
  <completion_date type="Actual">September 16, 2016</completion_date>
  <primary_completion_date type="Actual">September 16, 2016</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Only</observational_model>
    <time_perspective>Cross-Sectional</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Estimated Glomerular Filtration Rate (eGFR)</measure>
    <time_frame>Day 1</time_frame>
    <description>Kidney Function - To quantify the risk of kidney damage and the relationship to particulate matter exposure among first responders to the WTC attack.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Echocardiography</measure>
    <time_frame>Day 1</time_frame>
    <description>Cardiac structure - To examine the relationship between kidney damage and cardiac structure and function among first responders to the WTC attack.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Urine Albumin level</measure>
    <time_frame>Day 1</time_frame>
    <description>Cardiac function - To examine the relationship between kidney damage and cardiac structure and function among first responders to the WTC attack.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>High Sensitivity C-reactive Protein (hsCRP)</measure>
    <time_frame>Day 1</time_frame>
    <description>Endothelial Dysfunction - To explore potential mechanisms for kidney and cardiovascular damage among first responders to the WTC attack.</description>
  </secondary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">406</enrollment>
  <condition>Cardiac Disease</condition>
  <condition>Cardiopulmonary Disease</condition>
  <condition>Renal Disease</condition>
  <condition>Cardiovascular Disease</condition>
  <arm_group>
    <arm_group_label>WTC responders</arm_group_label>
    <description>WTC responders who were enrolled in the WTC-CHEST program.</description>
  </arm_group>
  <eligibility>
    <study_pop>
      <textblock>
        World Trade Center rescue and recovery workers and volunteers who are enrolled in the World&#xD;
        Trade Center Health Program-Clinical Center of Excellence, formerly known as the Medical&#xD;
        Monitoring Treatment Program and were subsequently enrolled in the WTC-CHEST program.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  WTC responders who were enrolled in the WTC-CHEST program.&#xD;
&#xD;
          -  World Trade Center responders who are currently enrolled in the World Trade Center&#xD;
             Health Program-Clinical Center of Excellence, formerly known as the WTC Medical&#xD;
             Monitoring and Treatment Program&#xD;
&#xD;
          -  Over the age of 39 years&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        -&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>40 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Mary Ann McLaughlin, MD, MPH</last_name>
    <role>Principal Investigator</role>
    <affiliation>Icahn School of Medicine at Mount Sinai</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Icahn School of Medicine at Mount Sinai</name>
      <address>
        <city>New York</city>
        <state>New York</state>
        <zip>10029</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
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    <citation>Sawit S MM, Garcia-Alvarez A, Fahima DK, Maceda C, Moline J. Evidence of Impaired Vascular Reactivity Following Dust Exposure in Participants of the World Trade Center Medical Monitoring and Treatment Program. New York City: Mount Sinai School of Medicine; 2011.</citation>
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  <verification_date>July 2017</verification_date>
  <study_first_submitted>September 16, 2014</study_first_submitted>
  <study_first_submitted_qc>September 18, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 22, 2014</study_first_posted>
  <last_update_submitted>July 25, 2017</last_update_submitted>
  <last_update_submitted_qc>July 25, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">July 26, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>cardiac disease</keyword>
  <keyword>cardiopulmonary disease</keyword>
  <keyword>renal disease</keyword>
  <keyword>albuminuria</keyword>
  <keyword>cardiovascular disease</keyword>
  <keyword>CVD</keyword>
  <keyword>particulate matter</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Kidney Diseases</mesh_term>
    <mesh_term>Cardiovascular Diseases</mesh_term>
    <mesh_term>Heart Diseases</mesh_term>
    <mesh_term>Pulmonary Heart Disease</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/NCT02246101
org study id: GCO 13-1847
secondary id: 1U01OH010716-01
nct id: NCT02246101
lead sponsor: 
collaborator: 
has dmc: Yes
Environmental toxins exert damaging health effects in workers. Thousands of responders who
      worked or volunteered on the World Trade Center (WTC) rescue and recovery effort following
      the September 11, 2001 attacks suffer from health conditions or may be at increased risk for
      worsening health. In a pilot study, investigators identified the first evidence of kidney
      damage in subjects with very high exposure at Ground Zero. Specifically, noted was a
      preliminary association between the intensity of particulate matter exposure and albuminuria,
      a marker of early chronic kidney disease (CKD), systemic endothelial dysfunction, and
      increased cardiovascular risk.

      The long-term goal is to minimize the risk of CKD and cardiovascular disease (CVD) among
      individuals exposed to inhaled toxins. The primary objective of this research is to quantify
      the risk of kidney damage among first responders to the WTC attack and to determine the
      relationship to particulate matter exposure as well as determine an association between renal
      and cardiovascular damage in first responders and to explore potential mechanisms. The
      central hypothesis is that exposure to inhaled particulate matter causes systemic
      inflammation and endothelial dysfunction that result in chronic kidney and cardiovascular
      damage. This hypothesis will be investigated in a subgroup of participants from a previously
      conducted NIOSH-funded study "Pulmonary Function Abnormalities, Diastolic Dysfunction and WTC
      Exposure: Implications for Diagnosis and Treatment" ("WTC-CHEST," PI Mary Ann McLaughlin).

      The proposed study will capitalize on unique resources in WTC-CHEST, including the
      standardized collection of data on particulate matter exposure and shared risk factors for
      CKD and cardiovascular disease, and cardiopulmonary function testing. The output from this
      proposal is anticipated to have a broad impact on understanding the health effects of inhaled
      particulate matter.
Specific Aim 1. To quantify the risk of kidney damage and the relationship to particulate
      matter exposure among first responders to the WTC attack.

      Urine samples will be collected on 2 occasions for albumin and creatinine. The investigators
      will define clinically relevant albuminuria as a UACR ≥30 mg/g. If, as hypothesized, the
      investigators find that albuminuria is more common among WTC responders, this simple and
      non-invasive measure may be useful in monitoring programs to identify responders at increased
      risk for adverse outcomes. eGFR will be calculated using the Chronic Kidney Disease
      Epidemiology Consortium (CKD-EPI) equations.

      Specific Aim 2. To examine the relationship between kidney damage and cardiac structure and
      function among first responders to the WTC attack.

      Cardiovascular Disease Risk Screening In order to identify an independent relationship
      between CKD and cardiac dysfunction, the investigators will comprehensively evaluate
      potential confounders. Participants will undergo an evaluation of traditional CVD risk
      factors as accounted for in both the Framingham Risk Score and Reynold's score (medical
      history, medication use and baseline risk for CVD: smoking status, family history of
      premature coronary disease, blood pressure, heart rate, height, weight, waist, hip and neck
      circumference). Laboratory evaluation will include: lipid panel, complete blood count, HbA1C,
      serum creatinine and cystatin C. Standard questionnaires on chest pain, shortness of breath,
      depression, sleep apnea and stress, IPSS.

      Specific Aim 3. To explore potential mechanisms for kidney and cardiovascular damage among
      first responders to the WTC attack.

      An established marker of systemic inflammation, serum hsCRP, will be measured in all
      participants. Flow-mediated dilatation, a validated non-invasive measure of endothelial
      function, will be measured in a subgroup of participants. Heavy metal assays will be
      performed and will be compared between participants with and without evidence of kidney
      damage (albuminuria or decreased eGFR) or proximal tubular dysfunction.
observational model: Case-Only
time perspective: Cross-Sectional
measure: Estimated Glomerular Filtration Rate (eGFR)
time frame: Day 1
description: Kidney Function - To quantify the risk of kidney damage and the relationship to particulate matter exposure among first responders to the WTC attack.
measure: Echocardiography
time frame: Day 1
description: Cardiac structure - To examine the relationship between kidney damage and cardiac structure and function among first responders to the WTC attack.
measure: Urine Albumin level
time frame: Day 1
description: Cardiac function - To examine the relationship between kidney damage and cardiac structure and function among first responders to the WTC attack.
measure: High Sensitivity C-reactive Protein (hsCRP)
time frame: Day 1
description: Endothelial Dysfunction - To explore potential mechanisms for kidney and cardiovascular damage among first responders to the WTC attack.
arm group label: WTC responders
description: WTC responders who were enrolled in the WTC-CHEST program.
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 40 Years
maximum age: N/A
healthy volunteers: No
last name: Mary Ann McLaughlin, MD, MPH
role: Principal Investigator
affiliation: Icahn School of Medicine at Mount Sinai
facility: 
country: United States
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citation: Sawit S MM, Garcia-Alvarez A, Fahima DK, Maceda C, Moline J. Evidence of Impaired Vascular Reactivity Following Dust Exposure in Participants of the World Trade Center Medical Monitoring and Treatment Program. New York City: Mount Sinai School of Medicine; 2011.
responsible party type: Sponsor
mesh term: Kidney Diseases
mesh term: Cardiovascular Diseases
mesh term: Heart Diseases
mesh term: Pulmonary Heart Disease