Ignite Creation Date:
2024-05-05 @ 12:01 PM
Last Modification Date:
2024-10-26 @ 9:18 AM
Study NCT ID:
NCT00215059
Status:
TERMINATED
Last Update Posted:
2012-08-02
First Post:
2005-09-15
Brief Title:
Measurement of Angiogenic Related Growth Factors in Urine and Blood From Patients With Pulmonary Vein Stenosis
Sponsor:
Boston Childrens Hospital
Organization:
Boston Childrens Hospital
Study Overview
Official Title:
Measurement of Angiogenic Related Growth Factors in Urine and Blood From Patients With Multivessel Pulmonary Vein Stenosis
Status:
TERMINATED
Status Verified Date:
2012-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Lack of funding
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Prospective single center descriptive study in 14 infantschildren 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
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 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 12 and ephrin At the time of blood draws approximately 4 ccs of heparin blood will be obtained and processed as detailed below Blood andor 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
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None