Ignite Creation Date:
2025-12-25 @ 12:45 AM
Ignite Modification Date:
2025-12-25 @ 10:58 PM
Study NCT ID:
NCT05485467
Status:
COMPLETED
Last Update Posted:
2023-11-08
First Post:
2022-06-23
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
The Role of CD34 + Stem Cells and Biomarkers in the Development of CAV in HTX Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D014652', 'term': 'Vascular Diseases'}], 'ancestors': [{'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 55}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-06-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-11', 'completionDateStruct': {'date': '2022-08-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-11-05', 'studyFirstSubmitDate': '2022-06-23', 'studyFirstSubmitQcDate': '2022-08-02', 'lastUpdatePostDateStruct': {'date': '2023-11-08', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-08-03', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-08-15', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'CD34+ peripheral cell count in heart transplant recipients with and without coronary allograft vasculopathy', 'timeFrame': 'at the time of enrollment', 'description': 'CD34+ peripheral cell count in heart transplant recipients with and without coronary allograft vasculopathy'}], 'secondaryOutcomes': [{'measure': 'The serum levels of biomarkers of angiogenesis in heart transplant recipients with and without coronary allograft vasculopathy', 'timeFrame': 'at the time of enrollment', 'description': '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'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['coronary allograft vasculopathy', 'CD34+ stem cells'], 'conditions': ['Vasculopathy', 'Heart Transplant Failure']}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients after heart transplantation, treated at Advanced Heart Failure and Transplantation Center, University Medical Center Ljubljana, Slovenia', 'eligibilityCriteria': 'Inclusion Criteria:\n\n* heart transplant recipient\n* age \\> 18 years\n* signed informed consent\n\nExclusion Criteria:\n\n* multiorgan transplantation\n* eGFR \\< 30 ml/min\n* known hypersensitivity to the contrast media\n* history of any malignancy treated with radiation or chemotherapy\n* therapy with mTOR inhibitors\n* rejection \\> 1R within 90 days before enrollment\n* G-CSF therapy within 30 days of enrollment'}, 'identificationModule': {'nctId': 'NCT05485467', 'briefTitle': 'The Role of CD34 + Stem Cells and Biomarkers in the Development of CAV in HTX Patients', 'organization': {'class': 'OTHER', 'fullName': 'University Medical Centre Ljubljana'}, 'officialTitle': 'The Role of CD34 + Stem Cells and Biological Markers of Angiogenesis in the Development of Coronary Allograft Vasculopathy in Patients After Heart Transplantation', 'orgStudyIdInfo': {'id': '02'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Heart transplant recipients', 'description': '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', 'interventionNames': ['Diagnostic Test: coronary CT angiography']}], 'interventions': [{'name': 'coronary CT angiography', 'type': 'DIAGNOSTIC_TEST', 'description': 'Coronary CT angiography will be performed on multislice Siemens Somat Force CT scanner', 'armGroupLabels': ['Heart transplant recipients']}]}, 'contactsLocationsModule': {'locations': [{'zip': '1000', 'city': 'Ljubljana', 'country': 'Slovenia', 'facility': 'Advanced Heart Failure and Transplantation Center, University Medical Center Ljubljana', 'geoPoint': {'lat': 46.05108, 'lon': 14.50513}}], 'overallOfficials': [{'name': 'Gregor Poglajen, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Advanced Heart Failure and Transplantation Center, Dept. of Cardiology, University Medical Center Ljubljana, Slovenia'}, {'name': 'Bojan Vrtovec, MD, PhD', 'role': 'STUDY_CHAIR', 'affiliation': 'bojan.vrtovec@kclj.si'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Medical Centre Ljubljana', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'MD, PhD', 'investigatorFullName': 'Gregor Poglajen', 'investigatorAffiliation': 'University Medical Centre Ljubljana'}}}}