Ignite Creation Date:
2024-05-06 @ 5:09 PM
Last Modification Date:
2024-10-26 @ 2:23 PM
Study NCT ID:
NCT05211024
Status:
COMPLETED
Last Update Posted:
2024-05-03
First Post:
2022-01-14
Brief Title:
A Long-term Follow up Study for Patients Who Participated in the GOAL Trial GOAL-Post
Sponsor:
Childrens Hospital Medical Center Cincinnati
Organization:
Childrens Hospital Medical Center Cincinnati
Study Overview
Official Title:
A Follow-up Study for Patients Who Participated in the GOAL Trial GOAL-Post
Status:
COMPLETED
Status Verified Date:
2024-08
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:
GOAL-Post is comprised of two studies that will help refine recommendations for the duration of secondary prophylaxis for children diagnosed with latent RHD which is currently not known
Detailed Description:
GOAL-Post is comprised of two studies that will help refine recommendations for the duration of secondary prophylaxis for children diagnosed with latent RHD which is currently not known
Aim 1 Compare the two-year risk of developing RHD borderline or definite between children and adolescents who completed the GOAL Trial with a normal echocardiogram prior diagnosis of latent RHD and agesexand geographically matched controls with repeated normal echocardiograms normal in both the original GOAL screening in 20172018 and in the planned GOAL-Post screening in 2021
Aim 2 Determine the five-year rate of RHD progression and regression among children with persistent latent RHD who receive secondary antibiotic prophylaxis medium-term impact of prophylaxis Five years includes time from initial GOAL enrollment to the end of GOAL-Post
Aim 3 Create a RHD biobank that will support further research on RHD genetic susceptibility and pathophysiology
Aim 1 Compare the two-year risk of developing RHD borderline or definite between children and adolescents who completed the GOAL Trial with a normal echocardiogram prior diagnosis of latent RHD and agesexand geographically matched controls with repeated normal echocardiograms normal in both the original GOAL screening in 20172018 and in the planned GOAL-Post screening in 2021
Aim 2 Determine the five-year rate of RHD progression and regression among children with persistent latent RHD who receive secondary antibiotic prophylaxis medium-term impact of prophylaxis Five years includes time from initial GOAL enrollment to the end of GOAL-Post
Aim 3 Create a RHD biobank that will support further research on RHD genetic susceptibility and pathophysiology
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None