Ignite Creation Date:
2024-05-06 @ 5:56 PM
Last Modification Date:
2024-10-26 @ 2:38 PM
Study NCT ID:
NCT05485467
Status:
COMPLETED
Last Update Posted:
2023-11-08
First Post:
2022-06-23
Brief Title:
The Role of CD34 Stem Cells and Biomarkers in the Development of CAV in HTX Patients
Sponsor:
University Medical Centre Ljubljana
Organization:
University Medical Centre Ljubljana
Study Overview
Official Title:
The Role of CD34 Stem Cells and Biological Markers of Angiogenesis in the Development of Coronary Allograft Vasculopathy in Patients After Heart Transplantation
Status:
COMPLETED
Status Verified Date:
2023-11
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:
Coronary allograft vasculopathy represents one of the major limiting factors of long-term survival in heart transplant recipients While extensively researched the underlying mechanisms of coronary allograft vasculopathy CAV after heart transplantation remain incompletely understood As CD34 cells represent one of the key determinants of coronary vascular homeostasis we investigated the potential association between CAV and CD34 cell count in heart transplant recipients
Detailed Description:
In a single-center prospective pilot cohort study we aim to enroll 55 adult heart transplant recipients All patients will undergo coronary CT angiography and the presence of CAV will be defined in accordance with the ISHLT criteria At the time of CT angiography patient will undergo detailed clinical evaluation cardiac echo and we will also collect blood samples perform extensive biochemical analysis and measure CD34 cell count in peripheral venous blood using Beckman-Coulter Navios EX flow cytometry with standard antibodies according to ISAGE protocol Biomarkers of angiogenesis will be evaluated using Luminex assay kit
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