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Measurement of Angiogenic Related Growth Factors in Urine and Blood From Patients With Pulmonary Vein Stenosis
This study is currently recruiting participants.
Verified by Children's Hospital Boston, March 2006
Sponsors and Collaborators: Children's Hospital Boston
Dana-Farber Cancer Institute
Information provided by: Children's Hospital Boston
ClinicalTrials.gov Identifier: NCT00215059
  Purpose

Prospective, single center, descriptive study in 14 infants/children with multivessel pulmonary vein stenosis stratified for patients with or without underlying cardiac disease.

Group 1: Patients without additional structural heart disease and multivessel pulmonary vein stenosis.

Group 2: Patients with additional structural heart disease and multivessel pulmonary vein stenosis.


Condition
Multivessel Pulmonary Vein Stenosis

MedlinePlus related topics: Urine and Urination
U.S. FDA Resources
Study Type: Observational
Study Design: Screening, Longitudinal, Defined Population, Prospective Study
Official Title: Measurement of Angiogenic Related Growth Factors in Urine and Blood From Patients With Multivessel Pulmonary Vein Stenosis

Further study details as provided by Children's Hospital Boston:

Estimated Enrollment: 14
Study Start Date: August 2000
Detailed Description:

Patients identified at the time of presentation to their cardiologist will be asked to provide a urine sample for analysis. If blood is being drawn for other clinical tests, an extra vial of blood will be collected for measurement of bFGF, VEGF, angiopoetin 1&2 and ephrin. At the time of blood draws, approximately 4 cc’s of heparin blood will be obtained and processed as detailed below. Blood and/or urine samples will be coordinated through the data manager and will be performed only when blood is being obtained for other reasons. Initially, blood samples will be sent to Lab Control, spun down, and the plasma isolated. Plasma will be coded, then frozen at –200C in the research lab. Urine samples will be aliquoted into vials and stored at –20 until further analysis.

All patient information will be kept confidential. Individual results will not be provided to patients. Identifiers to patient information will be maintained. No identifying patient information will be used in publications that might result from these studies. Information to be collected by the data manager will include age, sex, date of diagnosis and interventions.

The specific aim is to assess angiogenic growth factor concentrations in urine and blood from patients with both congenital and acquired multivessel pulmonary vein stenosis.

  Eligibility

Ages Eligible for Study:   up to 18 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Diagnosis can be based on clinical and radiographic grounds or at the time of biopsy or prior surgical procedures. The diagnosis must be consistent with multivessel pulmonary stenosis.
  • There must be evidence of severe pulmonary vein stenosis in at least two pulmonary veins.
  • Must give written informed consent according to institutional guidelines

Exclusion Criteria:

  • Mechanism of pulmonary venous obstruction due to obvious anatomic cause, such as extrinsic compression
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00215059

Contacts
Contact: Mark W Kieran, MD,PhD 617-632-4907 mark_kieran@dfci.harvard.edu
Contact: Kathy Jenkins 617-355-7275

Locations
United States, Massachusetts
Dana Farber Cancer Institute Recruiting
Boston, Massachusetts, United States, 02115
Contact: Mark W Kieran, MD,PhD     617-632-4907     mark_kieran@dfci.harvard.edu    
Contact: Caitlin M Briody, BA     617-632-5376     caitlin_briody@dfci.harvard.edu    
Principal Investigator: Mark W Kieran, MD, PhD            
Children's Hospital Boston Recruiting
Boston, Massachusetts, United States, 02115
Contact: Kathy Jenkins, MD     617-355-7275        
Sub-Investigator: Kathy Jenkins, MD            
Sponsors and Collaborators
Children's Hospital Boston
Dana-Farber Cancer Institute
Investigators
Principal Investigator: Mark W Kieran, MD,PhD Dana-Farber Cancer Institute
  More Information

Study ID Numbers: CH X00-09-050
Study First Received: September 15, 2005
Last Updated: March 31, 2006
ClinicalTrials.gov Identifier: NCT00215059  
Health Authority: United States: Institutional Review Board

Keywords provided by Children's Hospital Boston:
angiogenic related growth factor

Study placed in the following topic categories:
Pathological Conditions, Anatomical
Pulmonary veins stenosis
Constriction, Pathologic

ClinicalTrials.gov processed this record on January 14, 2009