Pulmonary HypertensionNCT00926523
Biomarkers in the Evaluation of Chronic Lung Disease
An observational study of Pulmonary Hypertension and Pulmonary Arterial Hypertension, run by Northwell Health at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Pulmonary Hypertension, Pulmonary Arterial Hypertension, Interstitial Lung Disease
- What is being tested?
- Blood Gas, Pulmonary Exercise Test and Spirometry
- How many people
- 67 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2009to Mar 2011
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Subjects are either a healthy volunteer, or someone who has confirmed Pulmonary Hypertension and Interstitial Lung Disease
Who may be able to join
- 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.
Who cannot join
- Subject are pregnant
- Subject is unable to perform tasks associated with study
Trial locations and contacts
1 site in 1 country.
United States1 site
Interstitial Lung Disease and Pulmonary Hypertension Programs
New Hyde Park, New York, 11040
About this study
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.
Read the 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:
- To evaluate plasma MIF concentration as a marker of severity in ILD and PH and
- 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.
- Being tested
- Blood Gas, Pulmonary Exercise Test, Spirometry, Breath Condensate Collector
- Keywords
- Pulmonary Hypertension, Pulmonary Arterial Hypertension, Interstitial Lung Disease, MIF
- Medical subject headings
- Hypertension, Pulmonary, Pulmonary Arterial Hypertension, Lung Diseases, Interstitial
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blood GasOther
Subject will have both venous and arterial blood draws to assess for the bloods content of MIF
Pulmonary Exercise TestOther
Subject will ride exercise bike to assess their pulmonary function level.
SpirometryOther
To assess subjects lung function
Breath Condensate CollectorOther
Subject with use breathing apparatus to allow researchers to collect breath condensate to assess level of MIF in breathe condensate.
| Study group | Role | What they receive |
|---|---|---|
| Healthy Controls | Subjects are made up of healthy adults Receives: Other: Blood Gas; Other: Pulmonary Exercise Test; Other: Spirometry; Other: Breath Condensate Collector | |
| Affected | Subjects have Pulmonary Hypertension Receives: Other: Blood Gas; Other: Pulmonary Exercise Test; Other: Spirometry; Other: Breath Condensate Collector |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jun 2009 (estimated)
- Study startJun 2009
- Primary completionMar 2011
- Study completionMar 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pulmonary HypertensionStudies of the same condition, open and under way.
- More trials run by Northwell HealthThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 67 participants (actual)
Sponsor and investigators
- Lead sponsor
- Northwell Health
- Sponsor type
- University, hospital or other
- Investigators
- Arunabh Talwar, M.D., Principal investigator, Northwell HealthEd Miller, Ph.D, Principal investigator, North Shore Long Island Jewish Healthy System
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00926523
- Sponsor's protocol ID
- GCRC 0274
- Status last verified
- May 2011
- First submitted
- 19 Jun 2009
- Last updated
- 27 May 2011
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 27 May 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Biomarkers in the Evaluation of Chronic Lung Disease
- ClinicalTrials.gov ID
- NCT00926523
- Acronym / sponsor ID
- GCRC 0274
- Keywords
- Pulmonary Hypertension, Pulmonary Arterial Hypertension, Interstitial Lung Disease, MIF
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 67 participants (actual)
- Lead sponsor
- Northwell HealthUniversity, hospital or other
- Study start
- Jun 2009
- Primary completion
- Mar 2011 (actual)
- Study completion
- Mar 2011 (actual)
- First posted
- 23 Jun 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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:
- To evaluate plasma MIF concentration as a marker of severity in ILD and PH and
- 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 design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Healthy Controls | – | Other: Blood Gas, Other: Pulmonary Exercise Test, Other: Spirometry, Other: Breath Condensate CollectorSubjects are made up of healthy adults |
| Affected | – | Other: Blood Gas, Other: Pulmonary Exercise Test, Other: Spirometry, Other: Breath Condensate CollectorSubjects have Pulmonary Hypertension |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Subjects are either a healthy volunteer, or someone who has confirmed Pulmonary Hypertension and Interstitial Lung Disease
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (2 listed)
- Subject are pregnant
- Subject is unable to perform tasks associated with study
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Blood GasSubject will have both venous and arterial blood draws to assess for the bloods content of MIF | Other | Affected, Healthy Controls |
| Pulmonary Exercise TestSubject will ride exercise bike to assess their pulmonary function level. | Other | Affected, Healthy Controls |
| SpirometryTo assess subjects lung function | Other | Affected, Healthy Controls |
| Breath Condensate CollectorSubject with use breathing apparatus to allow researchers to collect breath condensate to assess level of MIF in breathe condensate. | Other | Affected, Healthy Controls |
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 May 2011.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Arunabh Talwar, M.D. principal investigator
Northwell Health
Ed Miller, Ph.D principal investigator
North Shore Long Island Jewish Healthy System
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pulmonary Hypertension and Pulmonary Arterial Hypertension, run by Northwell Health at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 May 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 May 2011.