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Trial record 2 of 13 for:    "Alagille syndrome"

Characterization of Pulmonary Artery Stenoses in Alagille Syndrome - a Medical Record Review

This study is currently recruiting participants.
Verified October 2016 by Jeffrey A. Feinstein, Stanford University
Sponsor:
ClinicalTrials.gov Identifier:
NCT01515631
First Posted: January 24, 2012
Last Update Posted: October 18, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Information provided by (Responsible Party):
Jeffrey A. Feinstein, Stanford University
  Purpose
Patients who have Alagille Syndrome (AGS) also frequently have blockages (or "stenoses") of their pulmonary arteries. Little is known about the degree or variability of these stenoses, or the effect of this disease on the right ventricle (the chamber of the heart which pumps blood to the lungs). This study will first quantify and describe pulmonary artery stenosis in patients with Alagille Syndrome. The study will also assess the effect of these stenoses on the right ventricle. The investigators hope to learn the degree and characteristics of pulmonary artery stenosis in Alagille Syndrome. The investigators also hope to learn the effect of this pulmonary artery stenosis on the right ventricle in patients with Alagille Syndrome. This information is critical in the management of patients with Alagille syndrome, as there is currently no data to guide clinicians on the management of pulmonary artery stenosis. Furthermore, the information from this study may help physicians manage pulmonary artery stenosis in other patients as well.

Condition
Alagille Syndrome

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Retrospective
Official Title: Characterization of Pulmonary Artery Stenoses in Alagille Syndrome - a Medical Record

Resource links provided by NLM:


Further study details as provided by Jeffrey A. Feinstein, Stanford University:

Primary Outcome Measures:
  • Assessment of PA in Alagille Patient [ Time Frame: Open ]

Estimated Enrollment: 25
Study Start Date: April 2007
Estimated Study Completion Date: March 2018
Estimated Primary Completion Date: December 2017 (Final data collection date for primary outcome measure)
Groups/Cohorts
Study
Patients with alagille syndrome

Detailed Description:
The investigators hope to learn the degree and characteristics of pulmonary artery stenosis in Alagille Syndrome. We also hope to learn the effect of this pulmonary artery stenosis on the right ventricle in patients with Alagille Syndrome. This information is critical in the management of patients with Alagille syndrome, as there is currently no data to guide clinicians on the management of pulmonary artery stenosis. Furthermore, the information from this study may help physicians manage pulmonary artery stenosis in other patients as well. For the third aim, we hope to learn about the different blood vessel abnormalities in the brain, and which abnormalities are most likely to lead to stroke.
  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients with Alagille Syndrome. The age range will be from birth through adulthood. There will be no gender or ethnic limitations to study.
Criteria

Inclusion Criteria:

  • Diagnosis of Alagille Syndrome

Exclusion Criteria:

  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01515631


Contacts
Contact: Jeffrey Feinstein, MD, MPH 650 723 7913 jaf@stanford.edu

Locations
United States, California
Lucile Packard Children's Hospital at Stanford Recruiting
Palo Alto, California, United States, 94304
Principal Investigator: Jeffrey Feinstein, MD, MPH         
Sponsors and Collaborators
Stanford University
Investigators
Principal Investigator: Jeffrey Feinstein, MD, MPH Stanford University
  More Information

Responsible Party: Jeffrey A. Feinstein, Principal Investigator, Stanford University
ClinicalTrials.gov Identifier: NCT01515631     History of Changes
Other Study ID Numbers: AG9031
First Submitted: January 18, 2012
First Posted: January 24, 2012
Last Update Posted: October 18, 2016
Last Verified: October 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Additional relevant MeSH terms:
Alagille Syndrome
Syndrome
Stenosis, Pulmonary Artery
Disease
Pathologic Processes
Cholestasis, Intrahepatic
Cholestasis
Bile Duct Diseases
Biliary Tract Diseases
Digestive System Diseases
Liver Diseases
Heart Defects, Congenital
Cardiovascular Abnormalities
Cardiovascular Diseases
Abnormalities, Multiple
Congenital Abnormalities
Genetic Diseases, Inborn
Arterial Occlusive Diseases
Vascular Diseases