Biomarkers in the Evaluation of Chronic Lung Disease

NCT ID: NCT00926523

Last Updated: 2011-05-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

67 participants

Study Classification

OBSERVATIONAL

Study Start Date

2009-06-30

Study Completion Date

2011-03-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Pulmonary Hypertension Pulmonary Arterial Hypertension Interstitial Lung Disease

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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Healthy Controls

Subjects are made up of healthy adults

Blood Gas

Intervention Type OTHER

Subject will have both venous and arterial blood draws to assess for the bloods content of MIF

Pulmonary Exercise Test

Intervention Type OTHER

Subject will ride exercise bike to assess their pulmonary function level.

Spirometry

Intervention Type OTHER

To assess subjects lung function

Breath Condensate Collector

Intervention Type OTHER

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

Blood Gas

Intervention Type OTHER

Subject will have both venous and arterial blood draws to assess for the bloods content of MIF

Pulmonary Exercise Test

Intervention Type OTHER

Subject will ride exercise bike to assess their pulmonary function level.

Spirometry

Intervention Type OTHER

To assess subjects lung function

Breath Condensate Collector

Intervention Type OTHER

Subject with use breathing apparatus to allow researchers to collect breath condensate to assess level of MIF in breathe condensate.

Interventions

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Blood Gas

Subject will have both venous and arterial blood draws to assess for the bloods content of MIF

Intervention Type OTHER

Pulmonary Exercise Test

Subject will ride exercise bike to assess their pulmonary function level.

Intervention Type OTHER

Spirometry

To assess subjects lung function

Intervention Type OTHER

Breath Condensate Collector

Subject with use breathing apparatus to allow researchers to collect breath condensate to assess level of MIF in breathe condensate.

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Northwell Health

OTHER

Sponsor Role lead

Responsible Party

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North Shore LIJ Health System

Principal Investigators

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Arunabh Talwar, M.D.

Role: PRINCIPAL_INVESTIGATOR

Northwell Health

Ed Miller, Ph.D

Role: PRINCIPAL_INVESTIGATOR

North Shore Long Island Jewish Healthy System

Locations

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Interstitial Lung Disease and Pulmonary Hypertension Programs

New Hyde Park, New York, United States

Site Status

Countries

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United States

Other Identifiers

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GCRC 0274

Identifier Type: -

Identifier Source: org_study_id

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