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World Trade Center Kidney-Link

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ClinicalTrials.gov Identifier: NCT03234530
Recruitment Status : Recruiting
First Posted : July 31, 2017
Last Update Posted : November 14, 2018
Sponsor:
Collaborators:
Centers for Disease Control and Prevention
National Institute for Occupational Safety and Health (NIOSH/CDC)
Information provided by (Responsible Party):
Icahn School of Medicine at Mount Sinai

Brief Summary:

This study focuses on the prevalence and identification of kidney disease among participants of the WTC Health Program and the study team are planning to assess kidney disease in a multi-factorial manner. The first aim of this study is to correlate kidney dysfunction with 9/11 exposure, and the study team predicts that exposure to 9/11 is an independent risk factor in kidney disease among the WTC Health Program participants. Secondly, the study team proposes that a well-established WTC-related condition, obstructive sleep apnea (OSA), is independently associated with kidney disease. In addition, the study team believe there is a temporal causative relationship between evidence of kidney disease and the severity of OSA. Finally, the last aim is to further identify and explore potential mechanisms and phenotypes of kidney disease in participants of the WTC Health Programs.

Regardless of whether the analyses support or reject these hypotheses, the findings will be of equally great public health importance. Successful completion of the proposed research would address a critical knowledge gap regarding the risk of kidney damage among this group of patients, and would inform future mechanistic studies with the potential to impact prevention.


Condition or disease
Chronic Kidney Diseases Obstructive Sleep Apnea

  Show Detailed Description

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Study Type : Observational
Estimated Enrollment : 825 participants
Observational Model: Case-Control
Time Perspective: Cross-Sectional
Official Title: Linking the Effects of 9/11 to Kidney Disease
Actual Study Start Date : November 1, 2017
Estimated Primary Completion Date : June 30, 2020
Estimated Study Completion Date : June 30, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Kidney Diseases

Group/Cohort
WTC responders
WTC Health Program participants
Urban workers
Control group of urban workers in NYC not exposed to the dust from the WTC



Primary Outcome Measures :
  1. glomerular filtration rate (eGFR) [ Time Frame: day 1 ]
    eGFR will be calculated using the Chronic Kidney Disease Epidemiology Consortium (CKD-EPI) equations. The proposed studies will evaluate differences in the combined creatinine-cystatin C eGFR, which provides the most accurate estimate of GFR, and the creatinine-based CKD-EPI eGFR, which is more practical for use in clinical practice and in monitoring programs. Values > 200 will be set to 200mL/min/1.73m2

  2. albuminuria [ Time Frame: day 1 ]
    albumin level in urine


Secondary Outcome Measures :
  1. Berlin questionnaire [ Time Frame: day 1 ]
    Those who are not diagnosed with sleep apnea will be assessed for risk of developing sleep apnea using the Berlin questionnaire. It includes 11 questions organized into three categories, 5 questions related to snoring and the cessation of breathing in category 1, 4 questions related to daytime sleepiness in category 2, 1 question about high blood pressure, and 1 question regarding BMI in category 3. When two of three categories are classified as positive for a patient, the patient is rated as being at high risk of having OSA.

  2. apnea-hypopnea index (AHI) [ Time Frame: day 1 ]

    Those at high risk for sleep apnea will undergo home sleep a study test to determine apnea hypopnea index (AHI).

    Those diagnosed with sleep apnea, latest sleep study will be used to obtain AHI. To determine AHI, add the total number of apnea events, plus hypopnea events and divide by the total number of minutes of actual sleep time, then multiply by 60. AHI - Apnea Hypopnea Index - The # of apneas and hypopneas per hour.



Biospecimen Retention:   Samples Without DNA
Serum, plasma, urine


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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
World Trade Center rescue and recovery workers and volunteers who are enrolled or being seen in any WTC Clinical Centers of Excellence
Criteria

Inclusion Criteria:

- Exposed Group: - Adult patients (35 to 75 years)

  • Enrolled or was seen at any of the WTC Clinical Centers of Excellence

Unexposed Group: - Adult patients (35 to 75 years)

  • Lived or worked in NYC at least 10 years since 9/11/01 but were not exposed to the the dust at Ground Zero (not living in proximity of Ground Zero, nor involved in the rescue and recovery at Ground Zero

Registry Part: - Adult patient (18 to 75 years)

  • Enrolled or was seen at any of the WTC Clinical Centers of Excellence or WTC Environmental Health Centers
  • With a diagnosis of any Kidney Injury or disease after 9/11/01

Exclusion Criteria:

  • Patients below 18 years of age
  • Individuals with an occupation involving chronic exposure to inhaled particulate matter (e.g. iron/steel workers and sand hog workers)
  • For the registry part, patients with kidney disease prior to 9/11/01

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03234530


Contacts
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Contact: Cynara S. Maceda, MD 212-241-4693 cynara.maceda@mssm.edu
Contact: World Trade Center Kidney-Link study 212-241-1166

Locations
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United States, New York
Icahn School of Medicine at Mount Sinai Recruiting
New York, New York, United States, 10029
Contact: Cynara S. Maceda, MD    212-241-4693    cynara.maceda@mssm.edu   
Principal Investigator: Mary Ann McLaughlin, MD, MPH         
Sponsors and Collaborators
Icahn School of Medicine at Mount Sinai
Centers for Disease Control and Prevention
National Institute for Occupational Safety and Health (NIOSH/CDC)
Investigators
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Principal Investigator: Mary Ann McLaughlin, MD, MPH Icahn School of Medicine at Mount Sinai

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Responsible Party: Icahn School of Medicine at Mount Sinai
ClinicalTrials.gov Identifier: NCT03234530     History of Changes
Other Study ID Numbers: GCO 16-0899
U01OH011326-01A1 ( U.S. NIH Grant/Contract )
First Posted: July 31, 2017    Key Record Dates
Last Update Posted: November 14, 2018
Last Verified: November 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: The final research data will be a computerized dataset and includes self-reported demographic and medical data, responses from standard questionnaires, as well as results of laboratory tests (urine and blood samples) . Even though the final dataset will be stripped of identifiers prior to release for sharing, we believe that there remains the possibility of deductive disclosure of subjects with unusual characteristics. Thus, we will make the data and associated documentation available to users only under a data-sharing agreement that provides for: (1) a commitment to using the data only for research purposes and not to identify any individual participant; (2) a commitment to securing the data using appropriate computer technology; and (3) a commitment to destroying or returning the data after analyses are completed.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Icahn School of Medicine at Mount Sinai:
albuminuria
sleep apnea
particulate matter
renal injury
Additional relevant MeSH terms:
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Sleep Apnea Syndromes
Sleep Apnea, Obstructive
Apnea
Sleep Disorders, Intrinsic
Sleep Wake Disorders
Kidney Diseases
Renal Insufficiency, Chronic
Urologic Diseases
Respiration Disorders
Respiratory Tract Diseases
Dyssomnias
Nervous System Diseases
Renal Insufficiency