The Role of CD34 + Stem Cells and Biological Markers of Angiogenesis in the Development of Coronary Allograft Vasculopathy in Patients After Heart Transplantation
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
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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.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| 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, 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
Coronary CT angiography will be performed on multislice Siemens Somat Force CT scanner
|
Outcome Measures
Primary Outcome Measures
- Primary Outcome [at the time of enrollment]
CD34+ peripheral cell count in heart transplant recipients with and without coronary allograft vasculopathy
Secondary Outcome Measures
- Secondary outcome [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
Eligibility Criteria
Criteria
Inclusion Criteria:
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heart transplant recipient
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age > 18 years
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signed informed consent
Exclusion Criteria:
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multiorgan transplantation
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eGFR < 30 ml/min
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known hypersensitivity to the contrast media
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history of any malignancy treated with radiation or chemotherapy
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therapy with mTOR inhibitors
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rejection > 1R within 90 days before enrollment
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G-CSF therapy within 30 days of enrollment
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Advanced Heart Failure and Transplantation Center, University Medical Center Ljubljana | Ljubljana | Slovenia | 1000 |
Sponsors and Collaborators
- University Medical Centre Ljubljana
Investigators
- Principal Investigator: Gregor Poglajen, MD, PhD, Advanced Heart Failure and Transplantation Center, Dept. of Cardiology, University Medical Center Ljubljana, Slovenia
- Study Chair: Bojan Vrtovec, MD, PhD, bojan.vrtovec@kclj.si
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 02