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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:
ClinicalTrials.gov Identifier:
NCT00215059
First Posted: September 22, 2005
Last Update Posted: August 2, 2012
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. Read our disclaimer for details.
Collaborator:
Dana-Farber Cancer Institute
Information provided by:
Boston Children’s Hospital
  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 Boston Children’s Hospital:

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

Information from the National Library of Medicine

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Ages Eligible for Study:   up to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
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
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): NCT00215059


Locations
United States, Massachusetts
Children's Hospital Boston
Boston, Massachusetts, United States, 02115
Dana Farber Cancer Institute
Boston, Massachusetts, United States, 02115
Sponsors and Collaborators
Boston Children’s Hospital
Dana-Farber Cancer Institute
Investigators
Principal Investigator: Mark W Kieran, MD,PhD Dana-Farber Cancer Institute
  More Information

Responsible Party: Mark Kieran, Children's Hospital Boston
ClinicalTrials.gov Identifier: NCT00215059     History of Changes
Other Study ID Numbers: CH X00-09-050
First Submitted: September 15, 2005
First Posted: September 22, 2005
Last Update Posted: August 2, 2012
Last Verified: August 2012

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

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


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