World Trade Center Adolescent Health Study

NYU Langone Health

Status: Completed

Conditions: Hypertension; Asthma; Exposure to Toxic Dust; Insulin Resistance; Stress Disorders, Post-Traumatic; Cardiovascular Risk Factor

Study type: Observational

Funder types: Other

Identifiers

NCT02068183

U01OH010394 (U.S. NIH Grant/Contract)

S12-03116

Details and patient eligibility

About

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.

Full description

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).

Enrollment: 402 patients

Sex: All

Ages: 12 to 20 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• 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

Exclusion criteria

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

Trial design

402 participants in 2 patient groups

World Trade Center exposed group

Description:

After informed consent, anthropometric and blood pressure/brachial artery distensibility assessments; physical examination and environmental and respiratory history questionnaire completion; heart rate variability measurement; and spirometry/IOS will be performed on the World Trade Center exposed group. A research assistant well trained in pediatric phlebotomy will collect 23 mL of fasting blood. Spirometry and IOS, diet diary collection, lung volumes by plethysmography, and arterial wall stiffness.

Unexposed comparison group

Description:

After informed consent, anthropometric and blood pressure/brachial artery distensibility assessments; physical examination and environmental and respiratory history questionnaire completion; heart rate variability measurement; and spirometry/IOS will be performed on the unexposed comparison group. A research assistant well trained in pediatric phlebotomy will collect 23 mL of fasting blood. Spirometry and IOS, diet diary collection, lung volumes by plethysmography, and arterial wall stiffness.