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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05485467
Other study ID # 02
Secondary ID
Status Completed
Phase
First received
Last updated
Start date June 1, 2022
Est. completion date August 31, 2022

Study information

Verified date November 2023
Source University Medical Centre Ljubljana
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 55
Est. completion date August 31, 2022
Est. primary completion date August 15, 2022
Accepts healthy volunteers
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - heart transplant recipient - age > 18 years - signed informed consent Exclusion Criteria: - multiorgan transplantation - eGFR < 30 ml/min - known hypersensitivity to the contrast media - history of any malignancy treated with radiation or chemotherapy - therapy with mTOR inhibitors - rejection > 1R within 90 days before enrollment - G-CSF therapy within 30 days of enrollment

Study Design


Related Conditions & MeSH terms


Intervention

Diagnostic Test:
coronary CT angiography
Coronary CT angiography will be performed on multislice Siemens Somat Force CT scanner

Locations

Country Name City State
Slovenia Advanced Heart Failure and Transplantation Center, University Medical Center Ljubljana Ljubljana

Sponsors (1)

Lead Sponsor Collaborator
University Medical Centre Ljubljana

Country where clinical trial is conducted

Slovenia, 

Outcome

Type Measure Description Time frame Safety issue
Primary CD34+ peripheral cell count in heart transplant recipients with and without coronary allograft vasculopathy CD34+ peripheral cell count in heart transplant recipients with and without coronary allograft vasculopathy at the time of enrollment
Secondary The serum levels of biomarkers of angiogenesis in heart transplant recipients with and without coronary allograft vasculopathy The serum levels of biomarkers of angiogenesis (HIF 1a, SDF-1, IL-1, IL-6, TNFa, VEGF, FGF, EGF, Angiopoetin-2) in heart transplant recipients with and without coronary allograft vasculopathy at the time of enrollment
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