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OpenTrials
Completed

NCT Number: NCT05485467

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

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.

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Key information

Conditions

Vasculopathy Cardiovascular Diseases Heart Transplant Failure Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Advanced Heart Failure and Transplantation Center, University Medical Center Ljubljana

Ljubljana, 1000, Slovenia

About this study

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.

Who can participate

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Coronary CT angiography

Diagnostic Test

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

Primary outcomes

  1. CD34+ peripheral cell count in heart transplant recipients with and without coronary allograft vasculopathy

    Time frame: at the time of enrollment

    CD34+ peripheral cell count in heart transplant recipients with and without coronary allograft vasculopathy

Secondary outcomes

  1. The serum levels of biomarkers of angiogenesis in heart transplant recipients with and without coronary allograft vasculopathy

    Time frame: at the time of enrollment

    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

Sponsors and collaborators

Lead sponsor

University Medical Centre Ljubljana

Other

Registry information

Official study title

The Role of CD34 + Stem Cells and Biological Markers of Angiogenesis in the Development of Coronary Allograft Vasculopathy in Patients After Heart Transplantation

Important dates

Study start
2022
Primary completion
2022
Study completion
2022
First posted
Aug 3, 2022
Registry last updated
Nov 8, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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