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Biomarkers in the Evaluation of Chronic Lung Disease

This study has been completed.
Sponsor:
Information provided by:
North Shore Long Island Jewish Health System
ClinicalTrials.gov Identifier:
NCT00926523
First received: June 19, 2009
Last updated: May 26, 2011
Last verified: May 2011

June 19, 2009
May 26, 2011
June 2009
March 2011   (final data collection date for primary outcome measure)
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Not Provided
Complete list of historical versions of study NCT00926523 on ClinicalTrials.gov Archive Site
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Biomarkers in the Evaluation of Chronic Lung Disease
Biomarkers in the Evaluation of Chronic Lung Disease

We hypothesize that hypoxia-induced pulmonary vascular remodeling is mediated by macrophage migration inhibitory factor (MIF), that remodeling is in fact the reflection of a chronic inflammatory process, and that MIF may be a useful biomarker of the severity and progression of both ILD and PH.

We hypothesize that hypoxia-induced pulmonary vascular remodeling is mediated by macrophage migration inhibitory factor (MIF), that remodeling is in fact the reflection of a chronic inflammatory process, and that MIF may be a useful biomarker of the severity and progression of both ILD and PH.

To study this hypothesis, we have two specific aims:

  1. To evaluate plasma MIF concentration as a marker of severity in ILD and PH and
  2. To determine the utility of breathe condensate analysis in the evaluation of ILD and PH. If we are successful in identifying MIF as a biomarker, it may identify MIF as a useful therapeutic target, as we have shown in other inflammatory disorders.
Observational
Observational Model: Case Control
Time Perspective: Prospective
Not Provided
Retention:   Samples Without DNA
Description:

Exhaled breathe condensate.

Non-Probability Sample

Subjects are either a healthy volunteer, or someone who has confirmed Pulmonary Hypertension and Interstitial Lung Disease

  • Pulmonary Hypertension
  • Pulmonary Arterial Hypertension
  • Interstitial Lung Disease
  • Other: Blood Gas
    Subject will have both venous and arterial blood draws to assess for the bloods content of MIF
  • Other: Pulmonary Exercise Test
    Subject will ride exercise bike to assess their pulmonary function level.
  • Other: Spirometry
    To assess subjects lung function
  • Other: Breath Condensate Collector
    Subject with use breathing apparatus to allow researchers to collect breath condensate to assess level of MIF in breathe condensate.
  • Healthy Controls
    Subjects are made up of healthy adults
    Interventions:
    • Other: Blood Gas
    • Other: Pulmonary Exercise Test
    • Other: Spirometry
    • Other: Breath Condensate Collector
  • Affected
    Subjects have Pulmonary Hypertension
    Interventions:
    • Other: Blood Gas
    • Other: Pulmonary Exercise Test
    • Other: Spirometry
    • Other: Breath Condensate Collector
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
67
March 2011
March 2011   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Subject are at least 18 years of age
  • Subject has confirmed Pulmonary Hypertension and Interstitial Lung Disease
  • Subject are able to complete study procedures, such as spirometry, and Pulmonary Exercise test.

Exclusion Criteria:

  • Subject are pregnant
  • Subject is unable to perform tasks associated with study
Both
18 Years and older
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00926523
GCRC 0274
Yes
Arunabh Talwar M.D., North Shore LIJ Health System
North Shore Long Island Jewish Health System
Not Provided
Principal Investigator: Arunabh Talwar, M.D. North Shore LIJ Health System
Principal Investigator: Ed Miller, Ph.D North Shore Long Island Jewish Healthy System
North Shore Long Island Jewish Health System
May 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP