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World Trade Center (WTC) RENAL

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ClinicalTrials.gov Identifier: NCT02246101
Recruitment Status : Completed
First Posted : September 22, 2014
Last Update Posted : July 26, 2017
Sponsor:
Collaborator:
National Institute for Occupational Safety and Health (NIOSH/CDC)
Information provided by (Responsible Party):
Icahn School of Medicine at Mount Sinai

Brief Summary:

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.


Condition or disease
Cardiac Disease Cardiopulmonary Disease Renal Disease Cardiovascular Disease

Detailed Description:

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.


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Study Type : Observational
Actual Enrollment : 406 participants
Observational Model: Case-Only
Time Perspective: Cross-Sectional
Official Title: Renal and Cardiovascular Impairment in WTC Responders: Implications for Diagnosis and Treatment
Study Start Date : July 2014
Actual Primary Completion Date : September 16, 2016
Actual Study Completion Date : September 16, 2016

Group/Cohort
WTC responders
WTC responders who were enrolled in the WTC-CHEST program.



Primary Outcome Measures :
  1. Estimated Glomerular Filtration Rate (eGFR) [ Time Frame: Day 1 ]
    Kidney Function - To quantify the risk of kidney damage and the relationship to particulate matter exposure among first responders to the WTC attack.


Secondary Outcome Measures :
  1. Echocardiography [ Time Frame: Day 1 ]
    Cardiac structure - To examine the relationship between kidney damage and cardiac structure and function among first responders to the WTC attack.

  2. Urine Albumin level [ Time Frame: Day 1 ]
    Cardiac function - To examine the relationship between kidney damage and cardiac structure and function among first responders to the WTC attack.

  3. High Sensitivity C-reactive Protein (hsCRP) [ Time Frame: Day 1 ]
    Endothelial Dysfunction - To explore potential mechanisms for kidney and cardiovascular damage among first responders to the WTC attack.



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Ages Eligible for Study:   40 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
World Trade Center rescue and recovery workers and volunteers who are enrolled in the World Trade Center Health Program-Clinical Center of Excellence, formerly known as the Medical Monitoring Treatment Program and were subsequently enrolled in the WTC-CHEST program.
Criteria

Inclusion Criteria:

  • WTC responders who were enrolled in the WTC-CHEST program.
  • World Trade Center responders who are currently enrolled in the World Trade Center Health Program-Clinical Center of Excellence, formerly known as the WTC Medical Monitoring and Treatment Program
  • Over the age of 39 years

Exclusion Criteria:

-


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): NCT02246101


Locations
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United States, New York
Icahn School of Medicine at Mount Sinai
New York, New York, United States, 10029
Sponsors and Collaborators
Icahn School of Medicine at Mount Sinai
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

Publications:
Woodward M. Epidemiology: Study Design and Data Analysis. Third ed. CRC Press; 2014.
Nadkarni GN BE. Apolipoprotein L1 Gene Variants Associate with Increased Systolic and Diastolic Blood Pressure in Younger African Americans Independent of Renal Function American Society of Nephrology Kidney Week. Atlanta, GA2013.
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.

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Responsible Party: Icahn School of Medicine at Mount Sinai
ClinicalTrials.gov Identifier: NCT02246101     History of Changes
Other Study ID Numbers: GCO 13-1847
1U01OH010716-01 ( U.S. NIH Grant/Contract )
First Posted: September 22, 2014    Key Record Dates
Last Update Posted: July 26, 2017
Last Verified: July 2017
Keywords provided by Icahn School of Medicine at Mount Sinai:
cardiac disease
cardiopulmonary disease
renal disease
albuminuria
cardiovascular disease
CVD
particulate matter
Additional relevant MeSH terms:
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Kidney Diseases
Heart Diseases
Pulmonary Heart Disease
Cardiovascular Diseases
Urologic Diseases