Ignite Creation Date:
2024-05-06 @ 2:07 PM
Last Modification Date:
2024-10-26 @ 1:25 PM
Study NCT ID:
NCT04217343
Status:
UNKNOWN
Last Update Posted:
2022-08-22
First Post:
2019-12-09
Brief Title:
NCAMR-CAMR Allosure Study
Sponsor:
Tampa General Hospital
Organization:
Tampa General Hospital
Study Overview
Official Title:
NON-COMPLEMENT MEDIATED AMR vs COMPLEMENT MEDIATED AMR DOES DD-cfDNAGEP SHOW A DIFFERENCE
Status:
UNKNOWN
Status Verified Date:
2022-08
Last Known Status:
ENROLLING_BY_INVITATION
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:
Heart Transplant recipients at Tampa General Hospital heart transplant program who have pAMR1H or pAMR1I rejection will have a DD-cfDNA GEP sample obtained at the time of the rejection The DD-cfDNAGEP will then be drawn every month post treatment for the rejection until the DD-cfDNAGEP level returns to normal A total of fifteen recipients with pAMR1H and fifteen recipients with pAMR1I rejection will be included in the study which will last two years The presence of HLA antibodies DSAs and the titers presence of Autoantibodies the measurement of cytokines IL2 IL4 IL6 IL 10 IL 17 TNF alpha TGF beta the presence of coronary artery vasculopathy the time from transplant to the onset of the episode of AMR time to resolution the response to treatment and comparison to the DD-cfDNAGEP level with pAMR2 and pAMR 3 rejections will be analyzed
Detailed Description:
None
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