Measurement of Angiogenic Related Growth Factors in Urine and Blood From Patients With Pulmonary Vein Stenosis

This study has been terminated.
(Lack of funding)
Sponsor:
Collaborator:
Dana-Farber Cancer Institute
Information provided by:
Children's Hospital Boston
ClinicalTrials.gov Identifier:
NCT00215059
First received: September 15, 2005
Last updated: August 1, 2012
Last verified: August 2012
  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

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Measurement of Angiogenic Related Growth Factors in Urine and Blood From Patients With Multivessel Pulmonary Vein Stenosis

Resource links provided by NLM:


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

Estimated Enrollment: 50
Study Start Date: August 2000
Study Completion Date: July 2012
Primary Completion Date: July 2012 (Final data collection date for primary outcome measure)
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, angiopoietin 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
Sampling Method:   Non-Probability Sample
Study Population

patients with pulmonary vein stenosis

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

Locations
United States, Massachusetts
Dana Farber Cancer Institute
Boston, Massachusetts, United States, 02115
Children's Hospital Boston
Boston, Massachusetts, United States, 02115
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

No publications provided

Responsible Party: Mark Kieran, Children's Hospital Boston
ClinicalTrials.gov Identifier: NCT00215059     History of Changes
Other Study ID Numbers: CH X00-09-050
Study First Received: September 15, 2005
Last Updated: August 1, 2012
Health Authority: United States: Institutional Review Board

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

Additional relevant MeSH terms:
Constriction, Pathologic
Pathological Conditions, Anatomical
Mitogens
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions

ClinicalTrials.gov processed this record on April 23, 2014