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NCT02246101 · ClinicalTrials.gov registry record
World Trade Center (WTC) RENAL
A clinical trial, sponsored by Icahn School of Medicine at Mount Sinai.
- Completed
- Registry status
- 406
- Enrollment target
NCT02246101: Completed study, sponsored by Icahn School of Medicine at Mount Sinai.
NCT02246101 is a clinical trial that has completed, run by Icahn School of Medicine at Mount Sinai. The registered enrollment target is 406 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02246101 has completed, sponsored by Icahn School of Medicine at Mount Sinai.
- COMPLETED
- Registry status
- 406 participants
- Enrollment target
Study 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.
Primary Outcome
Kidney Function - To quantify the risk of kidney damage and the relationship to particulate matter exposure among first responders to the WTC attack.
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 406 participants |
| Start Date | 2014-07 |
| Est. Completion | 2016-09-16 |
What the finished NCT02246101 record still lists
NCT02246101 is an observational study that tracks outcomes without assigning an intervention. The registered 406 participants enrollment target is mid-sized for trials with a published cap.
The record links to 0 conditions, and to 0 interventions.
NCT02246101 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02246101 about?
NCT02246101 is a clinical study titled "World Trade Center (WTC) RENAL". 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 pi...
What is the current status of trial NCT02246101?
This trial is currently completed. The enrollment target is 406 participants. The study started on 2014-07. Estimated completion is 2016-09-16.
Who is sponsoring clinical trial NCT02246101?
This trial is sponsored by Icahn School of Medicine at Mount Sinai, which has 708 total clinical trials registered on ClinicalTrials.gov.
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