World Trade Center (WTC) RENAL

July 25, 2017 updated by: Icahn School of Medicine at Mount Sinai

Renal and Cardiovascular Impairment in WTC Responders: Implications for Diagnosis and Treatment

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.

Study Overview

Status

Completed

Conditions

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.

Study Type

Observational

Enrollment (Actual)

406

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • New York
      • New York, New York, United States, 10029
        • Icahn School of Medicine at Mount Sinai

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

40 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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.

Description

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:

-

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Day 1

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Day 1
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.
Day 1
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.
Day 1

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Icahn School of Medicine at Mount Sinai

Collaborators

National Institute for Occupational Safety and Health (NIOSH/CDC)

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2014

Primary Completion (ACTUAL)

September 16, 2016

Study Completion (ACTUAL)

September 16, 2016

Study Registration Dates

First Submitted

September 16, 2014

First Submitted That Met QC Criteria

September 18, 2014

First Posted (ESTIMATE)

September 22, 2014

Study Record Updates

Last Update Posted (ACTUAL)

July 26, 2017

Last Update Submitted That Met QC Criteria

July 25, 2017

Last Verified

July 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • GCO 13-1847
  • 1U01OH010716-01 (NIH)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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