The Study Of CT Scans and Echo Parameters in Patients Wit... | NCT00625963

Studies
The Study Of CT Scans and Echo Parameters in Patients With PAH

NCT00625963

Sponsor

Northwell Health

Status

Completed

Last Update Posted

Jul 30, 2013Estimated

Enrollment

71Actual

Phase

Not provided

Conditions

Pulmonary Hypertension

Interventions

Not provided

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jul 2013

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Apr 2007

Primary Completion Date

Jun 2008Actual

Completion Date

Jul 2011Actual

First Submitted Date

Feb 20, 2008

First Submission Date that Met QC Criteria

Feb 20, 2008

First Posted Date

Feb 29, 2008Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jul 29, 2013

Last Update Posted Date

Jul 30, 2013Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief 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. 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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

71Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
I,A		I=Pulmonary Hypertension Patients A=ILD patients with Pulmonary Hypertension Patients

Interventions

Not provided

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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.	All data has been previously collected.

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Pulmonary Hypertension;
ILD with Pulmonary Hypertension

Exclusion Criteria:

NON-PH

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

80 Years

Standard Ages

AdultOlder Adult

Study Population

Pulmonary Arterial Hypertension; Idiopathic Lung Disease

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Arunabh Talwar, MD	Northwell Health	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
North Shore-Long Island Jewish Health System		New Hyde Park	New York	11040	United States

Condition Browse Module

MeSH Terms

ID	Term
D006976	Hypertension, Pulmonary

Ancestor Terms

ID	Term
D008171	Lung Diseases
D012140	Respiratory Tract Diseases
D006973	Hypertension
D014652	Vascular Diseases

Browse Leaves

Not provided

Browse Branches

Not provided