Ignite Creation Date:
2024-05-05 @ 12:00 PM
Last Modification Date:
2024-10-26 @ 9:18 AM
Study NCT ID:
NCT00208689
Status:
TERMINATED
Last Update Posted:
2014-02-13
First Post:
2005-09-13
Brief Title:
Critical Congenital Heart Defect CHD Outcomes in Children
Sponsor:
Emory University
Organization:
Emory University
Study Overview
Official Title:
A Review of the Diagnosis Treatment and Outcomes of Children With Critical Congenital Heart Defects
Status:
TERMINATED
Status Verified Date:
2014-02
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:
Congenital heart disease in infants and children often challenges healthcare providers both in regards to diagnosis and in the management of these conditions The field becomes more complicated as one examines the myriad of defects that present and the complex care that is required Over the last 20-25 years the remarkable advances in the medical and surgical management of the most complex lesions have decreased neonatal mortality such that many more survive the neonatal period Therefore new challenges regarding the continued care of this patient cohort of high-risk infants and children exist In order to continue the improvement of treatments offered to these patients continuous review and analysis of the current standard of care is needed
In this study the investigators will collect information related to the current surgical and medical therapies offered to patients enrolled in the High Risk Congenital Heart Program at Childrens Healthcare of Atlanta All of the procedure and visit information will be a part of the childs standard of care This information will be placed in a database The investigators hope to learn more about the short-term and long-term effects of current therapies and procedures
In this study the investigators will collect information related to the current surgical and medical therapies offered to patients enrolled in the High Risk Congenital Heart Program at Childrens Healthcare of Atlanta All of the procedure and visit information will be a part of the childs standard of care This information will be placed in a database The investigators hope to learn more about the short-term and long-term effects of current therapies and procedures
Detailed Description:
Patients age newborn to 21 years followed in the High Risk Congenital Heart Defect Clinic at Childrens Healthcare of Atlanta at Egleston will be asked to participate in this trial The term high risk is assigned to a patient with the following diagnoses or medical problems critical aortic stenosis truncus arteriosus with or without interrupted aortic arch patients with complex single ventricle physiology such as hypoplastic left heart syndrome unbalanced AV canal tricuspid atresia transposition of the great vessels with ventricular septal defect and pulmonary stenosis mitral atresia pulmonary atresia with intact ventricular septum left ventricular outflow tract obstruction requiring Konno procedure transposition of the great vessels with or without ventricular septal defect pulmonary atresia with ventricular septal defect interrupted aortic arch with or without ventricular septal defect anatomy requiring double switch procedure aortic arch abnormality requiring transverse arch graft total anomalous pulmonary venous return anatomy requiring any of the following procedures Damas-Kaye-Stansel procedure ventricular septal defect enlargement or resection of subpulmonic stenosis during arterial switch procedure atrial septectomy neonatal repositioning of the tricuspid valve for Ebstein anomaly Ross procedure in infancy mitral stenosis with mitral valve replacement in infancy and any other cardiac abnormality requiring surgical repair in infancy with residual hemodynamically significant lesions In addition patients with infantile Marfan syndrome or kawasaki disease with coronary artery aneurysm will also be included
Informed consent will be obtained from the parent or legally authorized representative for all study participants An Assent either verbal or written will also be obtained if the child is over the age of six 6 A sequential and unique subject number ie NES001 NES002 will be assigned by the investigator or designee to each qualified subject after informed consent has been obtained Once a subject number is assigned it will not be used again by the investigator Subjects who are asked to participate but refuse participation in the study will not be assigned a study number
Investigational Plan
A single-center retrospective registry design will be utilized After consent the following data will be collected from each study participants chart each time he or she attends clinic
Name
Contact information or confirm contact information
Names of other care providers
Primary Diagnosis
Secondary Diagnoses
Age at time of visit
Vital signs including blood pressure heart rate respirations pulse oximetry
Weight at time of visit
If applicable echocardiography data including m-mode tissue doppler and color flow Doppler
History and Physical including surgical history
Medications
Nutritional Status
Growth Parameters
If applicable most recent standard of care laboratories
If applicable MRI results
EKG findings
All procedures are standard of care The collection of data for this registry will not effect the care provided to each patient The individual physician has the right to diagnose and treat each patient according to standard of care procedures and hisher own medical judgement
Participation in this registry will last as long as the patient is being followed in the high risk clinic at Childrens Healthcare of Atlanta
Informed consent will be obtained from the parent or legally authorized representative for all study participants An Assent either verbal or written will also be obtained if the child is over the age of six 6 A sequential and unique subject number ie NES001 NES002 will be assigned by the investigator or designee to each qualified subject after informed consent has been obtained Once a subject number is assigned it will not be used again by the investigator Subjects who are asked to participate but refuse participation in the study will not be assigned a study number
Investigational Plan
A single-center retrospective registry design will be utilized After consent the following data will be collected from each study participants chart each time he or she attends clinic
Name
Contact information or confirm contact information
Names of other care providers
Primary Diagnosis
Secondary Diagnoses
Age at time of visit
Vital signs including blood pressure heart rate respirations pulse oximetry
Weight at time of visit
If applicable echocardiography data including m-mode tissue doppler and color flow Doppler
History and Physical including surgical history
Medications
Nutritional Status
Growth Parameters
If applicable most recent standard of care laboratories
If applicable MRI results
EKG findings
All procedures are standard of care The collection of data for this registry will not effect the care provided to each patient The individual physician has the right to diagnose and treat each patient according to standard of care procedures and hisher own medical judgement
Participation in this registry will last as long as the patient is being followed in the high risk clinic at Childrens Healthcare of Atlanta
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