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临床试验/NCT02246101
NCT02246101已完成不适用

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

Icahn School of Medicine at Mount Sinai1 个研究点 分布在 1 个国家目标入组 406 人开始时间: 2014年7月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
406
试验地点
1
主要终点
Estimated Glomerular Filtration Rate (eGFR)

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Observational
观察模型
Case Only
时间视角
Cross Sectional

入排标准

年龄范围
40 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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

排除标准

  • 未提供

结局指标

主要结局

Estimated Glomerular Filtration Rate (eGFR)

时间窗: 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.

次要结局

  • Echocardiography(Day 1)
  • Urine Albumin level(Day 1)
  • High Sensitivity C-reactive Protein (hsCRP)(Day 1)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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