- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT02068183
World Trade Center Adolescent Health Study
Early Identification of World Trade Center Conditions in Adolescents
Studieoversikt
Status
Detaljert beskrivelse
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).
Studietype
Registrering (Faktiske)
Kontakter og plasseringer
Studiesteder
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New York
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New York, New York, Forente stater, 10016
- NYU School of Medicine
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Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Prøvetakingsmetode
Studiepopulasjon
Beskrivelse
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
Studieplan
Hvordan er studiet utformet?
Designdetaljer
Kohorter og intervensjoner
Gruppe / Kohort |
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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.
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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.
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Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
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Pulmonary Function Testing
Tidsramme: One time
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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.
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One time
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Oscillometry
Tidsramme: One time
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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.
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One time
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Plethysmography
Tidsramme: One time
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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.
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One time
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Blood Pressure
Tidsramme: One time
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We will perform assess systolic (first Korotkoff phase) and diastolic (fifth Korotkoff phase) BP three consecutive times in all participants.
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One time
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Arterial Wall Stiffness
Tidsramme: One time
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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.
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One time
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Heart Rate Variability
Tidsramme: One time
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Assessment of Heart Rate Variability (HRV) will be performed using the SphgymoCor SCOR-CPV device (AtCor Medical, Sydney, Australia).
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One time
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Insulin resistance
Tidsramme: One time
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Fasting insulin and blood glucose will be assessed.
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One time
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Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
---|---|---|
Lipid levels
Tidsramme: One time
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Fasting blood draw will be performed.
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One time
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Psychosocial stress and mental health outcomes
Tidsramme: One time
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One time
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Tobacco smoke exposure
Tidsramme: One time
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We will measure tobacco smoke exposure from salivary cotinine.
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One time
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Andre resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
---|---|---|
Physical activity questionnaire
Tidsramme: One time
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Questionnaire adapted from the International Physical Activity Questionnaire-Short last seven days
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One time
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Diet history questionnaire
Tidsramme: One time
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web-based Diet History Questionnaire II developed by the National Cancer Institute
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One time
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Samarbeidspartnere og etterforskere
Sponsor
Etterforskere
- Hovedetterforsker: Leonardo Trasande, MD, MPP, NYU Sch of Med
Publikasjoner og nyttige lenker
Generelle publikasjoner
- 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. Epub 2012 Dec 29.
- Gaylord A, Berger KI, Naidu M, Attina TM, Gilbert J, Koshy TT, Han X, Marmor M, Shao Y, Giusti R, Goldring RM, Kannan K, Trasande L. Serum perfluoroalkyl substances and lung function in adolescents exposed to the World Trade Center disaster. Environ Res. 2019 May;172:266-272. doi: 10.1016/j.envres.2019.02.024. Epub 2019 Feb 16.
- Trye A, Berger KI, Naidu M, Attina TM, Gilbert J, Koshy TT, Han X, Marmor M, Shao Y, Giusti R, Goldring RM, Trasande L. Respiratory Health and Lung Function in Children Exposed to the World Trade Center Disaster. J Pediatr. 2018 Oct;201:134-140.e6. doi: 10.1016/j.jpeds.2018.06.009. Epub 2018 Jul 18.
- Trasande L, Koshy TT, Gilbert J, Burdine LK, Marmor M, Han X, Shao Y, Chemtob C, Attina TM, Urbina EM. Cardiometabolic profiles of adolescents and young adults exposed to the World Trade Center Disaster. Environ Res. 2018 Jan;160:107-114. doi: 10.1016/j.envres.2017.09.026. Epub 2017 Sep 30.
- Koshy TT, Attina TM, Ghassabian A, Gilbert J, Burdine LK, Marmor M, Honda M, Chu DB, Han X, Shao Y, Kannan K, Urbina EM, Trasande L. Serum perfluoroalkyl substances and cardiometabolic consequences in adolescents exposed to the World Trade Center disaster and a matched comparison group. Environ Int. 2017 Dec;109:128-135. doi: 10.1016/j.envint.2017.08.003. Epub 2017 Sep 8.
Studierekorddatoer
Studer hoveddatoer
Studiestart
Primær fullføring (Faktiske)
Studiet fullført (Faktiske)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Anslag)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Anslag)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- S12-03116
- U01OH010394 (U.S. NIH-stipend/kontrakt)
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