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临床试验/NCT02068183
NCT02068183已完成不适用

Early Identification of World Trade Center Conditions in Adolescents

NYU Langone Health1 个研究点 分布在 1 个国家目标入组 402 人开始时间: 2013年12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
402
试验地点
1
主要终点
Blood Pressure

研究概览

简要总结

The proposed study builds upon preliminary studies in self-selected populations to identify opportunities for early identification of World Trade Center-related health consequences in adolescents. If adverse health consequences are identified, proactive cardiometabolic and pulmonary screening of exposed children may be indicated, with targeted interventions intended to prevent development of chronic obstructive pulmonary disease, and adverse cardiometabolic outcomes in adulthood.

详细描述

The study will assess the potential for longer-latency cardiometabolic and pulmonary effects of early life exposure to the World Trade Center (WTC) disaster, and to identify opportunities for early identification of WTC-related health consequences. Preliminary data from the only investigators who regularly provide clinical care to children who lived/attended school near the WTC site identified decrements in spirometry associated with dust cloud exposure, and a remarkably high frequency of cardiometabolic risk factors. Findings from this clinically, self-selected population cannot be extrapolated to the entire population of children who were exposed to the disaster but nonetheless suggest that further study is warranted of the possible metabolic and cardiovascular consequences of WTC exposures. If associated with WTC exposures in a larger, more representative sample, two new and innovative techniques, oscillometry and pulse wave velocity assessment, hold great promise for earlier detection of WTC-related pulmonary and cardiometabolic disease, for whom dietary, environmental and medication interventions may prevent disease progression in later life.

The study will recruit 225 adolescents who respond to the WTC Health Registry (WTCHR), the most representative pediatric population and best-characterized from an environmental exposure standpoint. Connecting the study to the WTCHR also presents efficiency of federal resource utilization, providing more objective clinical data to support self-reported findings of increased persistent respiratory symptoms captured by the WTCHR, thereby improving reliability of the registry data. We will compare pulmonary and cardiometabolic outcomes to carefully matched (age, race/ethnicity, gender, and socioeconomic status) and unexposed control (not resident/attending school south of Houston Street on September 11, 2001) populations from NYU School of Medicine affiliated primary care (private and public clinics).

研究设计

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

入排标准

年龄范围
12 Years 至 20 Years(Child, Adult)
性别
All
接受健康志愿者

入选标准

  • WTCHR participants (exposed group): previous response to WTCHR, born between September 11, 1993 and September 10, 2001
  • Controls who are did not live or attend school south of Canal Street on September 11, 2001, matched for age, race/ethnicity, socioeconomic status and other characteristics

排除标准

  • Inability to follow procedures.
  • Serious lung or heart condition
  • Heart or lung surgery
  • Uncontrolled asthma
  • Current upper respiratory infection
  • Pregnancy

结局指标

主要结局

Blood Pressure

时间窗: One time

We will perform assess systolic (first Korotkoff phase) and diastolic (fifth Korotkoff phase) BP three consecutive times in all participants.

Pulmonary Function Testing

时间窗: One time

We will perform spirometry according to standards outlined by the American Thoracic Society and the European Respiratory Society. Specifically, we will assess forced vital capacity (FVC), forced expiratory volume in 1 second (FEV1), FEV1/FVC ratio, and forced expiratory flow over 25-75% of the vital capacity (FEF25-75%; Jaeger Masterscreen IOS; Carefusion, Yorba Linda, CA). National Health and Nutrition Examination Survey (NHANES) III reference equations will be used to determine normative values, with statistical analysis to be applied to percents of predicted volumes based on these norms.

Oscillometry

时间窗: One time

Oscillometry provides a noninvasive measure of the impedance to airflow within the lung. An externally-generated pressure impulse is applied during tidal breathing in a seated position for 30 seconds, and volume and flow measurements are made.

Arterial Wall Stiffness

时间窗: One time

Pulse Wave Velocity (PWV) will be measured using the SphygmoCor CPV System (AtCor Medical, Sydney, Australia). PWV measures the speed for the pressure wave generated by cardiac ejection to reach the periphery.

Heart Rate Variability

时间窗: One time

Assessment of Heart Rate Variability (HRV) will be performed using the SphgymoCor SCOR-CPV device (AtCor Medical, Sydney, Australia).

Plethysmography

时间窗: One time

Measured lung volumes will include total lung capacity (TLC), vital capacity (VC), residual volume (RV), and functional residual capacity (FRC) and will be compared to normative values, using established pediatric reference equations.

Insulin resistance

时间窗: One time

Fasting insulin and blood glucose will be assessed.

次要结局

  • Psychosocial stress and mental health outcomes(One time)
  • Tobacco smoke exposure(One time)
  • Lipid levels(One time)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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