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

Study Status: Terminated
Recruit Status: Terminated
Study Type: Observational

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

Brief Summary:

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.

Detailed Summary:

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.

Sponsor: Boston Children’s Hospital

Current Primary Outcome:

Original Primary Outcome:

Current Secondary Outcome:

Original Secondary Outcome:

Information By: Boston Children’s Hospital

Dates:
Date Received: September 15, 2005
Date Started: August 2000
Date Completion:
Last Updated: August 1, 2012
Last Verified: August 2012