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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Vasculopathy, Heart Transplant Failure

Intervention / Treatment
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* Diagnostic Test: coronary CT angiography


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Heart transplant recipients<br>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, the patient will undergo a detailed clinical evaluation, and cardiac echo and we will also collect blood samples, perform extensive biochemical analysis and measure CD34+ cell count in peripheral venous blood | Diagnostic Test: coronary CT angiography<br>* Coronary CT angiography will be performed on multislice Siemens Somat Force CT scanner<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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coronary allograft vasculopathy, CD34+ stem cells