Ignite Creation Date:
2024-05-05 @ 12:09 PM
Last Modification Date:
2024-10-26 @ 9:21 AM
Study NCT ID:
NCT00263120
Status:
COMPLETED
Last Update Posted:
2016-08-24
First Post:
2005-12-05
Brief Title:
Effects of Thymectomy During Cardiothoracic Surgery
Sponsor:
University of California Los Angeles
Organization:
University of California Los Angeles
Study Overview
Official Title:
None
Status:
COMPLETED
Status Verified Date:
2016-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The thymus is known to be the site of T cell development in humans Due to its location in the chest in front of the heart incidental thymecomy is commonly performed during cardiothoracic surgery especially in infants and children so that surgeons may gain access to the surgical field This practice has been considered safe because it was thought that the thymus is inactive after birth However recent data using newly developed techniques has demonstrated that the thymus normally is active well into adulthood In addition in a previous study UCLA IRB 02-03-008-02 we have demonstrated alterations in lymphocyte T cells number in individuals who have undergone thymectomy in childhood but we do not know how immunity is affected We plan to investigate if immune development or immune function later in life is affected by the loss of T cell production caused by thymectomy during cardiothoracic surgical procedures in childhood At UCLA a large number of patients are seen who have congenital heart disease and undergo surgical procedures for correction or repair and many children and adults are followed for many years after they have undergone surgical procedures Subjects for study will be recruited from among these patients
We propose a study which will examine the number and activity of lymphocytes obtained from blood samples from child and young adult subjects who have undergone surgery in early childhood We will determine if these subjects have had complete thymectomy in the past using CT or MRI obtained during routine care or for subjects who are having cardiothoracic surgery by visualization of thymic tissue during the procedure In addition we will give vaccination for a common viral illness hepatitis A and measure immune responses to it from a blood sample As part of this study we will ask for medical information consisting of a history of congenital cardiac disease and other diagnoses such as asthma a history of infections and hospitalizations and information about immunizations We will also ask about a list of specific symptoms which will give us information about the function of the immune system
We propose a study which will examine the number and activity of lymphocytes obtained from blood samples from child and young adult subjects who have undergone surgery in early childhood We will determine if these subjects have had complete thymectomy in the past using CT or MRI obtained during routine care or for subjects who are having cardiothoracic surgery by visualization of thymic tissue during the procedure In addition we will give vaccination for a common viral illness hepatitis A and measure immune responses to it from a blood sample As part of this study we will ask for medical information consisting of a history of congenital cardiac disease and other diagnoses such as asthma a history of infections and hospitalizations and information about immunizations We will also ask about a list of specific symptoms which will give us information about the function of the immune system
Detailed Description:
None
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