VasculopathyNCT05485467
The Role of CD34 + Stem Cells and Biomarkers in the Development of CAV in HTX Patients
An observational study of Vasculopathy and Heart Transplant Failure, run by University Medical Centre Ljubljana at 1 site in Slovenia.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Vasculopathy, Heart Transplant Failure
- What is being tested?
- coronary CT angiography
- How many people
- 55 participants
- Where
- 1 siteSlovenia
- Study dates
- 1 Jun 2022to 31 Aug 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Adult, Older adult
Study population: Patients after heart transplantation, treated at Advanced Heart Failure and Transplantation Center, University Medical Center Ljubljana, Slovenia
Who may be able to join
- heart transplant recipient
- age > 18 years
- signed informed consent
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Slovenia1 site
Advanced Heart Failure and Transplantation Center, University Medical Center Ljubljana
Ljubljana, 1000
About this study
Official title: 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.
Read the 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.
- Conditions
- Vasculopathy, Heart Transplant Failure
- Being tested
- coronary CT angiography
- Keywords
- coronary allograft vasculopathy, CD34+ stem cells
- Medical subject headings
- Vascular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
coronary CT angiographyDiagnostic test
Coronary CT angiography will be performed on multislice Siemens Somat Force CT scanner
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Diagnostic Test: coronary CT angiography |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: at the time of enrollment
Secondary outcomes (1)
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
Measured: at the time of enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Aug 2022
- Study start1 Jun 2022
- Primary completion15 Aug 2022
- Study completion31 Aug 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for VasculopathyStudies of the same condition, open and under way.
- More trials run by University Medical Centre LjubljanaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 55 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Medical Centre Ljubljana
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Gregor Poglajen, University Medical Centre Ljubljana
- Investigators
- Gregor Poglajen, MD, PhD, Principal investigator, Advanced Heart Failure and Transplantation Center, Dept. of Cardiology, University Medical Center Ljubljana, SloveniaBojan Vrtovec, MD, PhD, Study chair, bojan.vrtovec@kclj.si
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05485467
- Sponsor's protocol ID
- 02
- Status last verified
- Nov 2023
- First submitted
- 23 Jun 2022
- Last updated
- 8 Nov 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Role of CD34 + Stem Cells and Biological Markers of Angiogenesis in the Development of Coronary Allograft Vasculopathy in Patients After Heart Transplantation
- ClinicalTrials.gov ID
- NCT05485467
- Acronym / sponsor ID
- 02
- Conditions
- Vasculopathy, Heart Transplant Failure
- Keywords
- coronary allograft vasculopathy, CD34+ stem cells
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 55 participants (actual)
- Lead sponsor
- University Medical Centre LjubljanaUniversity, hospital or other
- Study start
- 1 Jun 2022 (actual)
- Primary completion
- 15 Aug 2022 (actual)
- Study completion
- 31 Aug 2022 (actual)
- First posted
- 3 Aug 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Heart transplant recipients | – | Diagnostic Test: coronary CT angiographyAll 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Patients after heart transplantation, treated at Advanced Heart Failure and Transplantation Center, University Medical Center Ljubljana, Slovenia
Key inclusion criteria (3 listed)
- heart transplant recipient
- age > 18 years
- signed informed consent
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| coronary CT angiographyCoronary CT angiography will be performed on multislice Siemens Somat Force CT scanner | Diagnostic test | Heart transplant recipients |
Primary outcome
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
1 secondary outcome
The serum levels of biomarkers of angiogenesis in heart transplant recipients with and without coronary allograft vasculopathy
Time frame: at the time of enrollment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Nov 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Gregor Poglajen, MD, PhD principal investigator
Advanced Heart Failure and Transplantation Center, Dept. of Cardiology, University Medical Center Ljubljana, Slovenia
Bojan Vrtovec, MD, PhD study chair
bojan.vrtovec@kclj.si
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Vasculopathy and Heart Transplant Failure, run by University Medical Centre Ljubljana at 1 site in Slovenia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Slovenia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
CD34+ peripheral cell count in heart transplant recipients with and without coronary allograft vasculopathy (time frame: at the time of enrollment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Nov 2023.