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Sponsors and Collaborators: |
Children's Hospital Boston Dana-Farber Cancer Institute |
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Information provided by: | Children's Hospital Boston |
ClinicalTrials.gov Identifier: | NCT00215059 |
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 |
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Multivessel Pulmonary Vein Stenosis |
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 |
Estimated Enrollment: | 14 |
Study Start Date: | August 2000 |
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.
Ages Eligible for Study: | up to 18 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Mark W Kieran, MD,PhD | 617-632-4907 | mark_kieran@dfci.harvard.edu |
Contact: Kathy Jenkins | 617-355-7275 |
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 |
Principal Investigator: | Mark W Kieran, MD,PhD | Dana-Farber Cancer Institute |
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 |
angiogenic related growth factor |
Pathological Conditions, Anatomical Pulmonary veins stenosis Constriction, Pathologic |