World Trade Center Adolescent Health Study

This study is currently recruiting participants. (see Contacts and Locations)
Verified February 2014 by New York University School of Medicine
Sponsor:
Information provided by (Responsible Party):
New York University School of Medicine
ClinicalTrials.gov Identifier:
NCT02068183
First received: January 22, 2014
Last updated: February 18, 2014
Last verified: February 2014
  Purpose

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.


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

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Cross-Sectional
Official Title: Early Identification of World Trade Center Conditions in Adolescents

Resource links provided by NLM:


Further study details as provided by New York University School of Medicine:

Primary Outcome Measures:
  • Pulmonary Function Testing [ Time Frame: One time ] [ Designated as safety issue: No ]
    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 [ Time Frame: One time ] [ Designated as safety issue: No ]
    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.

  • Plethysmography [ Time Frame: One time ] [ Designated as safety issue: No ]
    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.

  • Blood Pressure [ Time Frame: One time ] [ Designated as safety issue: No ]
    We will perform assess systolic (first Korotkoff phase) and diastolic (fifth Korotkoff phase) BP three consecutive times in all participants.

  • Arterial Wall Stiffness [ Time Frame: One time ] [ Designated as safety issue: No ]
    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 [ Time Frame: One time ] [ Designated as safety issue: No ]
    Assessment of Heart Rate Variability (HRV) will be performed using the SphgymoCor SCOR-CPV device (AtCor Medical, Sydney, Australia).

  • Insulin resistance [ Time Frame: One time ] [ Designated as safety issue: No ]
    Fasting insulin and blood glucose will be assessed.


Secondary Outcome Measures:
  • Lipid levels [ Time Frame: One time ] [ Designated as safety issue: No ]
    Fasting blood draw will be performed.

  • Psychosocial stress and mental health outcomes [ Time Frame: One time ] [ Designated as safety issue: No ]
    1. WTC disaster trauma—We will measure psychologically relevant WTC exposure, using questions about direct exposure, family/friend exposure, and media exposure.
    2. Other lifetime trauma
    3. Depression
    4. Substance abuse, and other diagnoses
    5. Post-traumatic stress disorder
    6. Functional impairment
    7. Mental health service utilization

  • Tobacco smoke exposure [ Time Frame: One time ] [ Designated as safety issue: No ]
    We will measure tobacco smoke exposure from salivary cotinine.


Other Outcome Measures:
  • Physical activity questionnaire [ Time Frame: One time ] [ Designated as safety issue: No ]
    Questionnaire adapted from the International Physical Activity Questionnaire-Short last seven days

  • Diet history questionnaire [ Time Frame: One time ] [ Designated as safety issue: No ]
    web-based Diet History Questionnaire II developed by the National Cancer Institute


Biospecimen Retention:   Samples With DNA

A research assistant well trained in pediatric phlebotomy will collect 25 mL of blood at the first visit, as one aliquot of 3 ml blood in a lavender top vacutainer for CBC, one aliquot of 5 ml blood in a goldtop vacutainer for whole blood, and one 3 ml of blood in a PAX Gene (PreAnalitycX - Hombrechtikon, Switzerland) tube for RNA isolation. One 4 ml cryovial of whole blood will be reserved for future DNA analysis and heavy metal analysis, and another 10 ml vacutainer will be reserved for persistent organic pollutants, while the blood in the PAX Gene will be stored for RNA isolation.


Estimated Enrollment: 450
Study Start Date: December 2013
Estimated Study Completion Date: February 2016
Estimated Primary Completion Date: January 2016 (Final data collection date for primary outcome measure)
Groups/Cohorts
World Trade Center exposed group
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
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.

Detailed 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).

  Eligibility

Ages Eligible for Study:   12 Years to 20 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

The study population for the present proposal will be drawn from the pediatric component of the WTCHR, a cohort of 71,436 adults and children who were first interviewed in 2003-04. To further investigate the associations of WTC exposures with health outcomes, we will compare health parameters in the cohort of WTCHR registrants with 225 subjects in a control cohort drawn from pediatric and adolescent clinics in Manhattan and Brooklyn.

Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02068183

Contacts
Contact: Leonardo Trasande, MD, MPP 6465012520 leonardo.trasande@nyumc.org
Contact: Sung A Jenny Lee, MPH (646)501-9166 JennySung.Lee@nyumc.org

Locations
United States, New York
NYU School of Medicine Recruiting
New York, New York, United States, 10016
Contact: Jenny Lee, MPH    646-501-9166    jennysung.lee@nyumc.org   
Principal Investigator: Leonardo Trasande, MD, MPP         
Sponsors and Collaborators
New York University School of Medicine
Investigators
Principal Investigator: Leonardo Trasande, MD, MPP NYU Sch of Med
  More Information

Publications:
Responsible Party: New York University School of Medicine
ClinicalTrials.gov Identifier: NCT02068183     History of Changes
Other Study ID Numbers: S12-03116, U01OH010394
Study First Received: January 22, 2014
Last Updated: February 18, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by New York University School of Medicine:
World Trade Center exposure
cardiovascular risk
insulin resistance
post-traumatic stress
pulmonary disease

Additional relevant MeSH terms:
Hypertension
Stress Disorders, Traumatic
Insulin Resistance
Stress Disorders, Post-Traumatic
Vascular Diseases
Cardiovascular Diseases
Anxiety Disorders
Mental Disorders
Hyperinsulinism
Glucose Metabolism Disorders
Metabolic Diseases

ClinicalTrials.gov processed this record on September 18, 2014