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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
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05485467
Enrollment
55
Registered
2022-08-03
Start date
2022-06-01
Completion date
2022-08-31
Last updated
2023-11-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Vasculopathy, Heart Transplant Failure

Keywords

coronary allograft vasculopathy, CD34+ stem cells

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.

Interventions

Coronary CT angiography will be performed on multislice Siemens Somat Force CT scanner

Sponsors

University Medical Centre Ljubljana
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum

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

Design outcomes

Primary

MeasureTime frameDescription
CD34+ peripheral cell count in heart transplant recipients with and without coronary allograft vasculopathyat the time of enrollmentCD34+ peripheral cell count in heart transplant recipients with and without coronary allograft vasculopathy

Secondary

MeasureTime frameDescription
The serum levels of biomarkers of angiogenesis in heart transplant recipients with and without coronary allograft vasculopathyat the time of enrollmentThe 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

Countries

Slovenia

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026