Biomarkers in the Evaluation of Chronic Lung Disease

May 26, 2011 updated by: Northwell Health
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Actual)

67

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • New York
      • New Hyde Park, New York, United States, 11040
        • Interstitial Lung Disease and Pulmonary Hypertension Programs

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

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

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Northwell Health

Investigators

  • Principal Investigator: Arunabh Talwar, M.D., Northwell Health
  • Principal Investigator: Ed Miller, Ph.D, North Shore Long Island Jewish Healthy System

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2009

Primary Completion (Actual)

March 1, 2011

Study Completion (Actual)

March 1, 2011

Study Registration Dates

First Submitted

June 19, 2009

First Submitted That Met QC Criteria

June 19, 2009

First Posted (Estimate)

June 23, 2009

Study Record Updates

Last Update Posted (Estimate)

May 27, 2011

Last Update Submitted That Met QC Criteria

May 26, 2011

Last Verified

May 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • GCRC 0274

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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