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

November 5, 2023 updated by: Gregor Poglajen, University Medical Centre Ljubljana

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Actual)

55

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Slovenia
      • Ljubljana, Slovenia, 1000
        • Advanced Heart Failure and Transplantation Center, University Medical Center Ljubljana

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

N/A

Sampling Method

Non-Probability Sample

Study Population

Patients after heart transplantation, treated at Advanced Heart Failure and Transplantation Center, University Medical Center Ljubljana, Slovenia

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
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
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
at the time of enrollment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

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 record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 1, 2022

Primary Completion (Actual)

August 15, 2022

Study Completion (Actual)

August 31, 2022

Study Registration Dates

First Submitted

June 23, 2022

First Submitted That Met QC Criteria

August 2, 2022

First Posted (Actual)

August 3, 2022

Study Record Updates

Last Update Posted (Estimated)

November 8, 2023

Last Update Submitted That Met QC Criteria

November 5, 2023

Last Verified

November 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 02

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Heart Transplant Failure

Clinical Trials on coronary CT angiography

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Argentina

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe