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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

55 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-06-01

Study Completion Date

2022-08-31

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.

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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.

Conditions

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Vasculopathy Heart Transplant Failure

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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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

coronary CT angiography

Intervention Type DIAGNOSTIC_TEST

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

Interventions

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coronary CT angiography

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

Intervention Type DIAGNOSTIC_TEST

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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No