World Trade Center Kidney-Link
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|ClinicalTrials.gov Identifier: NCT03234530|
Recruitment Status : Recruiting
First Posted : July 31, 2017
Last Update Posted : November 14, 2018
This study focuses on the prevalence and identification of kidney disease among participants of the WTC Health Program and the study team are planning to assess kidney disease in a multi-factorial manner. The first aim of this study is to correlate kidney dysfunction with 9/11 exposure, and the study team predicts that exposure to 9/11 is an independent risk factor in kidney disease among the WTC Health Program participants. Secondly, the study team proposes that a well-established WTC-related condition, obstructive sleep apnea (OSA), is independently associated with kidney disease. In addition, the study team believe there is a temporal causative relationship between evidence of kidney disease and the severity of OSA. Finally, the last aim is to further identify and explore potential mechanisms and phenotypes of kidney disease in participants of the WTC Health Programs.
Regardless of whether the analyses support or reject these hypotheses, the findings will be of equally great public health importance. Successful completion of the proposed research would address a critical knowledge gap regarding the risk of kidney damage among this group of patients, and would inform future mechanistic studies with the potential to impact prevention.
|Condition or disease|
|Chronic Kidney Diseases Obstructive Sleep Apnea|
Show Detailed Description
|Study Type :||Observational|
|Estimated Enrollment :||825 participants|
|Official Title:||Linking the Effects of 9/11 to Kidney Disease|
|Actual Study Start Date :||November 1, 2017|
|Estimated Primary Completion Date :||June 30, 2020|
|Estimated Study Completion Date :||June 30, 2020|
WTC Health Program participants
Control group of urban workers in NYC not exposed to the dust from the WTC
- glomerular filtration rate (eGFR) [ Time Frame: day 1 ]eGFR will be calculated using the Chronic Kidney Disease Epidemiology Consortium (CKD-EPI) equations. The proposed studies will evaluate differences in the combined creatinine-cystatin C eGFR, which provides the most accurate estimate of GFR, and the creatinine-based CKD-EPI eGFR, which is more practical for use in clinical practice and in monitoring programs. Values > 200 will be set to 200mL/min/1.73m2
- albuminuria [ Time Frame: day 1 ]albumin level in urine
- Berlin questionnaire [ Time Frame: day 1 ]Those who are not diagnosed with sleep apnea will be assessed for risk of developing sleep apnea using the Berlin questionnaire. It includes 11 questions organized into three categories, 5 questions related to snoring and the cessation of breathing in category 1, 4 questions related to daytime sleepiness in category 2, 1 question about high blood pressure, and 1 question regarding BMI in category 3. When two of three categories are classified as positive for a patient, the patient is rated as being at high risk of having OSA.
- apnea-hypopnea index (AHI) [ Time Frame: day 1 ]
Those at high risk for sleep apnea will undergo home sleep a study test to determine apnea hypopnea index (AHI).
Those diagnosed with sleep apnea, latest sleep study will be used to obtain AHI. To determine AHI, add the total number of apnea events, plus hypopnea events and divide by the total number of minutes of actual sleep time, then multiply by 60. AHI - Apnea Hypopnea Index - The # of apneas and hypopneas per hour.
Biospecimen Retention: Samples Without DNA
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03234530
|Contact: Cynara S. Maceda, MDemail@example.com|
|Contact: World Trade Center Kidney-Link study||212-241-1166|
|United States, New York|
|Icahn School of Medicine at Mount Sinai||Recruiting|
|New York, New York, United States, 10029|
|Contact: Cynara S. Maceda, MD 212-241-4693 firstname.lastname@example.org|
|Principal Investigator: Mary Ann McLaughlin, MD, MPH|
|Principal Investigator:||Mary Ann McLaughlin, MD, MPH||Icahn School of Medicine at Mount Sinai|