NCT05485467

The Role of CD34 + Stem Cells and Biomarkers in the Development of CAV in HTX Patients

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
• Phase: —
• Study type: Observational
• Enrollment: 55 (actual)
• Sponsor: University Medical Centre Ljubljana · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: —

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.

Conditions

• Vasculopathy
• Heart Transplant Failure

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	coronary CT angiography	Coronary CT angiography will be performed on multislice Siemens Somat Force CT scanner

Timeline

• Start date: 2022-06-01
• Primary completion: 2022-08-15
• Completion: 2022-08-31
• First posted: 2022-08-03
• Last updated: 2023-11-08

Locations

1 site across 1 country: Slovenia