Pericoronary Adipocyte Size Gradient
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age30-90
SponsorInstitute for Clinical and Experimental Medicine
About this trial
Evaluation of pericoronary adipocyte gradient (PCAT) in relationship with local atherosclerotic changes in a patient undergoing heart transplantation.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Age 30-90 years
Diagnosis of dilatational or ischemic cardiomyopathy
Patients undergoing heart transplantation in IKEM
Disqualifiers
Known combined diagnosis of dilatational and ischemic cardiomyopathy
Arrhythmogenic cardiomyopathy
Congenital heart defects
Non-eligibility due to the absence of informed consent
Trial population
The study population comprises patients who underwent heart transplantation for heart failure at the Institute for Clinical and Experimental Medicine, Cardiovascular Surgery Department, between June 2023 and December 2028. Only the subjects' ret-rospective clinical data and matching heart samples will be analyzed.
Trial design
Design model
Other
Time perspective
Cross-sectional
Treatments tested in this trial
Heart transplantation for the final stage of heart failure
Procedure/SurgeryThe study population comprises patients who underwent heart transplantation for heart failure at the Institute for Clinical and Experimental Medicine, Cardiovascular Surgery Department, between June 2023 and December 2028. Only the subjects' retrospective clinical data and matching heart samples will be analyzed.
Treatment groups
60 Participants
are divided into 1 treatment groupGroup A: patients with advanced heart failure1 intervention
Trial outcomes
Primary outcomes
1
Adipocyte size
Assessment of the difference (in square micrometer) between adipocyte size closely adjacent to the coronary artery and those more distant from the arterial lumen in relation to atherosclerotic pathologies in situ
Time frame
Perioperative/PeriproceduralSecondary outcomes
1
Immunological parameters
The immunological characteristics-T cells (counts and percentages), B cells (counts and percentages), macrophages and their subpopulations (counts and percentages)-and the immunohistochemical biomarkers sclerostin, TREM-2 (triggering receptor expressed on myeloid cells 2), and mimecan (score) in the arterial wall and pericoronary adipose tissue (PCAT) will be analyzed and compared.
Time frame
Perioperative/Periprocedural2
Morphological parameters
The morphological characteristics-atherosclerotic plaque type (category) and calcification rate (percentage)-in the arterial wall and pericoronary adipose tissue (PCAT) will be analyzed and compared.
Time frame
Perioperative/PeriproceduralSponsors and contacts
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Source ClinicalTrials.gov