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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
History of Changes
  Purpose

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.


Condition Intervention
Pulmonary Hypertension
Pulmonary Arterial Hypertension
Interstitial Lung Disease
 Other: Blood Gas
Other: Pulmonary Exercise Test
Other: Spirometry
Other: Breath Condensate Collector

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Prospective
Official Title: Biomarkers in the Evaluation of Chronic Lung Disease

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by North Shore Long Island Jewish Health System:

Biospecimen Retention:   Samples Without DNA

Exhaled breathe condensate.


Enrollment: 67
Study Start Date: June 2009
Study Completion Date: March 2011
Primary Completion Date: March 2011 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Healthy Controls
Subjects are made up of healthy adults
 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.
Affected
Subjects have Pulmonary Hypertension
 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.

Detailed Description:

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.
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

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

Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00926523

Locations
United States, New York
Interstitial Lung Disease and Pulmonary Hypertension Programs
New Hyde Park, New York, United States, 11040
Sponsors and Collaborators
North Shore Long Island Jewish Health System
Investigators
Principal Investigator: Arunabh Talwar, M.D. North Shore LIJ Health System
Principal Investigator: Ed Miller, Ph.D North Shore Long Island Jewish Healthy System
  More Information

No publications provided

Responsible Party: Arunabh Talwar M.D., North Shore LIJ Health System
ClinicalTrials.gov Identifier: NCT00926523     History of Changes
Other Study ID Numbers: GCRC 0274
Study First Received: June 19, 2009
Last Updated: May 26, 2011
Health Authority: United States: Institutional Review Board

Keywords provided by North Shore Long Island Jewish Health System:
Pulmonary Hypertension
Pulmonary Arterial Hypertension
Interstitial Lung Disease
MIF

Additional relevant MeSH terms:
Hypertension, Pulmonary
Hypertension
Lung Diseases
Pulmonary Fibrosis
 Lung Diseases, Interstitial
Respiratory Tract Diseases
Vascular Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on May 23, 2013