World Trade Center (WTC) RENAL

NCT02246101 | Completed DMC

• 2 other identifiers: GCO 13-18471U01OH010716-01
• Study Type: observational
• Target: 406
• Locations: 1 country
• Sites: 1

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.

Conditions

Cardiac Disease; Cardiopulmonary Disease; Renal Disease; Cardiovascular Disease

Keywords

cardiac disease; cardiopulmonary disease; renal disease; albuminuria; cardiovascular disease; CVD; particulate matter

Outcome Measures

Primary Outcomes (1)

• Estimated Glomerular Filtration Rate (eGFR)

  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 Outcomes (3)

• Echocardiography

  Day 1

• Urine Albumin level

  Day 1

• High Sensitivity C-reactive Protein (hsCRP)

  Day 1

Study Arms (1)

WTC responders

WTC responders who were enrolled in the WTC-CHEST program.

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

Sponsors & Collaborators

• Icahn School of Medicine at Mount Sinai: lead
• National Institute for Occupational Safety and Health (NIOSH/CDC): collaborator

Study Sites (1)

Icahn School of Medicine at Mount Sinai

New York, New York, 10029, United States

Location

Related Publications (51)

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  BACKGROUND

MeSH Terms

Conditions

Heart Diseases; Pulmonary Heart Disease; Kidney Diseases; Cardiovascular Diseases; Albuminuria

Condition Hierarchy (Ancestors)

Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Proteinuria; Urination Disorders; Urological Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Mary Ann McLaughlin, MD, MPH

  Icahn School of Medicine at Mount Sinai

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 16, 2014
• First Posted: September 22, 2014
• Study Start: July 1, 2014
• Primary Completion: September 16, 2016
• Study Completion: September 16, 2016
• Last Updated: July 26, 2017

Record last verified: 2017-07

Locations

US (1)