Pulmonary HypertensionNCT00625963
The Study Of CT Scans and Echo Parameters in Patients With PAH
An observational study of Pulmonary Hypertension, run by Northwell Health at 1 site in United States.
Trial summary
Current standard of the diagnosis and monitoring of PHNT requiring combination of invasive and non-invasive tests. The goal of the study is to correlate data from CT scans, echocardiograms, right heart catheterization, PFTs, sleep studies, and perfusion scans. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Pulmonary Hypertension
- How many people
- 71 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2007to Jul 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Pulmonary Arterial Hypertension; Idiopathic Lung Disease
Who may be able to join
- Pulmonary Hypertension;
- ILD with Pulmonary Hypertension
Who cannot join
- NON-PH
Trial locations and contacts
1 site in 1 country.
United States1 site
North Shore-Long Island Jewish Health System
New Hyde Park, New York, 11040
About this study
Official title: The Study of CT Scan and Echocardiogram Parameters in Patients With Pulmonary Hypertension With Regards to Hemodynamics, Sleep Studies, and Various Laboratory Markers.
Current standard of the diagnosis and monitoring of PHNT requiring combination of invasive and non-invasive tests. The goal of the study is to correlate data from CT scans, echocardiograms, right heart catheterization, PFTs, sleep studies, and perfusion scans. The ultimate goal is to determine patterns of the PAH disease processes.
Read the detailed description
The goal of our study is to correlate data from various non-invasive tests such as commuted tomography (CT) imaging, echocardiogram, Pulmonary Function Tests, and other laboratory tests along with hemodynamic measurements from Right Heart Catheterizations in these ILD patients with Pulmonary Hypertension, as well as all other pulmonary hypertension. The ultimate goal is to determine patterns of the PAH disease processes, as well as define optimal diagnostic modalities including in-hospital verses outpatient studies.
- Conditions
- Pulmonary Hypertension
- Keywords
- Pulmonary Hypertension;, ILD;, CT Imaging;, Echocardiogram;, Hemodynamic measurements of RHC., Pulmonary Function Tests
- Medical subject headings
- Hypertension, Pulmonary
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| I,A | I=Pulmonary Hypertension Patients A=ILD patients with Pulmonary Hypertension Patients |
What is being measured
The primary outcome is the main question the study is designed to answer.
The Study Of CT Scans and Echo Parameters in Patients With PAH
Correlation of Pulmonary artery diameter as measured by CT scan and Pulmonary artery systolic pressure as measured by Echocardiogram.
Measured: All data has been previously collected.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Feb 2008 (estimated)
- Study startApr 2007
- Primary completionJun 2008
- Study completionJul 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
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 71 participants (actual)
Sponsor and investigators
- Lead sponsor
- Northwell Health
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Arunabh Talwar, MD, Principal investigator, Northwell Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00625963
- Sponsor's protocol ID
- 07.060
- Status last verified
- Jul 2013
- First submitted
- 20 Feb 2008
- Last updated
- 30 Jul 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Jul 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Study of CT Scan and Echocardiogram Parameters in Patients With Pulmonary Hypertension With Regards to Hemodynamics, Sleep Studies, and Various Laboratory Markers.
- ClinicalTrials.gov ID
- NCT00625963
- Acronym / sponsor ID
- 07.060
- Conditions
- Pulmonary Hypertension
- Keywords
- Pulmonary Hypertension;, ILD;, CT Imaging;, Echocardiogram;, Hemodynamic measurements of RHC., Pulmonary Function Tests
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 71 participants (actual)
- Lead sponsor
- Northwell HealthUniversity, hospital or other
- Study start
- Apr 2007
- Primary completion
- Jun 2008 (actual)
- Study completion
- Jul 2011 (actual)
- First posted
- 29 Feb 2008 (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.
Current standard of the diagnosis and monitoring of PHNT requiring combination of invasive and non-invasive tests. The goal of the study is to correlate data from CT scans, echocardiograms, right heart catheterization, PFTs, sleep studies, and perfusion scans. The ultimate goal is to determine patterns of the PAH disease processes.
Detailed description
The goal of our study is to correlate data from various non-invasive tests such as commuted tomography (CT) imaging, echocardiogram, Pulmonary Function Tests, and other laboratory tests along with hemodynamic measurements from Right Heart Catheterizations in these ILD patients with Pulmonary Hypertension, as well as all other pulmonary hypertension. The ultimate goal is to determine patterns of the PAH disease processes, as well as define optimal diagnostic modalities including in-hospital verses outpatient studies.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| I,A | – | –I=Pulmonary Hypertension Patients A=ILD patients with Pulmonary Hypertension Patients |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Pulmonary Arterial Hypertension; Idiopathic Lung Disease
Key inclusion criteria (2 listed)
- Pulmonary Hypertension;
- ILD with Pulmonary Hypertension
Key exclusion criteria (1 listed)
- NON-PH
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
The Study Of CT Scans and Echo Parameters in Patients With PAH
Time frame: All data has been previously collected.
Correlation of Pulmonary artery diameter as measured by CT scan and Pulmonary artery systolic pressure as measured by Echocardiogram.
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 30 Jul 2013.
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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, MD principal investigator
Northwell Health
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, 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 2 inclusion and 1 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 30 Jul 2013. 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.
What does the primary outcome measure?
The Study Of CT Scans and Echo Parameters in Patients With PAH (time frame: All data has been previously collected.). It is what the study was designed to measure, not a finding.
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 30 Jul 2013.