Pericoronary Adipocyte Size Gradient
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Heart transplantation for the final stage of heart failure.
- Who it may be relevant to
- Registry conditions: Heart Failure, Heart Transplantation. Basic parameters: 30 years — 90 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Czechia
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Direct Measurement of Pericoronary Adipocyte Size Gradient as a Parameter of Immunometabolic Changes of Perivascular Adipose Tissue
Overview
Evaluation of pericoronary adipocyte gradient (PCAT) in relationship with local atherosclerotic changes in a patient undergoing heart transplantation.
Detailed description
The project is designed to analyze the impact of inflammation spreading from pericoro-nary adipose tissue to the arterial wall or vice versa. Adipocyte size and immunometabolic parameters gradients established from independent analysis of samples closely adjacent to the coronary artery and those more distant from the arterial lumen will be used to establish the direction of inflammation propagation. The coronary arteries, along with adjacent pericoronary adipose tissue, from explanted hearts will be obtained during heart transplantation of patients with advanced atherosclerosis (ischemic heart disease) and with less advanced atherosclerotic disease (dilated cardiomyopathy).
Clinical data (including age, BMI, comorbidities, and concomitant medications) will be recorded. Specifically, previous left ventricular assist device (LVAD) implantation, used as a bridge-to-transplant approach, will be followed to establish the effect of artificial hemodynamic disturbance on coronary artery blood flow on study endpoints.
Interventions
- Procedure Heart transplantation for the final stage of heart failure
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' retrospective clinical data and matching heart samples will be analyzed.
Primary outcome measures
- Adipocyte size [Time frame: Perioperative/Periprocedural]
Secondary outcome measures (2)
- Immunological parameters [Time frame: Perioperative/Periprocedural]
- Morphological parameters [Time frame: Perioperative/Periprocedural]
Eligibility criteria
Inclusion criteria
- Age 30-90 years
- Diagnosis of dilatational or ischemic cardiomyopathy
- Patients undergoing heart transplantation in IKEM
Exclusion criteria
- Known combined diagnosis of dilatational and ischemic cardiomyopathy
- Arrhythmogenic cardiomyopathy
- Congenital heart defects
- Non-eligibility due to the absence of informed consent
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Other
Study locations
Czechia · 1 center
- Centre of Experimental Medicine, Institute for Clinical and Experimental Medicine, — Prague
Identifiers
NCT: NCT07360925 · AdipoCor2023