World Trade Center Adolescent Health Study

Hypertension Clinical Trial

Official title:

Early Identification of World Trade Center Conditions in Adolescents

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02068183
• Other study ID #: S12-03116
• Secondary ID: U01OH010394
• Status: Completed
• Phase: N/A
• First received: January 22, 2014
• Last updated: January 23, 2017
• Start date: December 2013
• Est. completion date: March 2016

Study information

• Verified date: January 2017
• Source: New York University School of Medicine
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 402
• Est. completion date: March 2016
• Est. primary completion date: March 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 12 Years to 20 Years

Eligibility

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

Related Conditions & MeSH terms

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

Locations

Country	Name	City	State
United States	NYU School of Medicine	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
New York University School of Medicine

Country where clinical trial is conducted

United States, 

References & Publications (1)

Trasande L, Fiorino EK, Attina T, Berger K, Goldring R, Chemtob C, Levy-Carrick N, Shao Y, Liu M, Urbina E, Reibman J. Associations of World Trade Center exposures with pulmonary and cardiometabolic outcomes among children seeking care for health concerns. Sci Total Environ. 2013 Feb 1;444:320-6. doi: 10.1016/j.scitotenv.2012.11.097. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Physical activity questionnaire	Questionnaire adapted from the International Physical Activity Questionnaire-Short last seven days	One time
Other	Diet history questionnaire	web-based Diet History Questionnaire II developed by the National Cancer Institute	One time
Primary	Pulmonary Function Testing	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.	One time
Primary	Oscillometry	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.	One time
Primary	Plethysmography	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.	One time
Primary	Blood Pressure	We will perform assess systolic (first Korotkoff phase) and diastolic (fifth Korotkoff phase) BP three consecutive times in all participants.	One time
Primary	Arterial Wall Stiffness	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.	One time
Primary	Heart Rate Variability	Assessment of Heart Rate Variability (HRV) will be performed using the SphgymoCor SCOR-CPV device (AtCor Medical, Sydney, Australia).	One time
Primary	Insulin resistance	Fasting insulin and blood glucose will be assessed.	One time
Secondary	Lipid levels	Fasting blood draw will be performed.	One time
Secondary	Psychosocial stress and mental health outcomes	WTC disaster trauma—We will measure psychologically relevant WTC exposure, using questions about direct exposure, family/friend exposure, and media exposure.; Other lifetime trauma; Depression; Substance abuse, and other diagnoses; Post-traumatic stress disorder; Functional impairment; Mental health service utilization	One time
Secondary	Tobacco smoke exposure	We will measure tobacco smoke exposure from salivary cotinine.	One time