Skip to content

Pericoronary Adipocyte Size Gradient

Direct Measurement of Pericoronary Adipocyte Size Gradient as a Parameter of Immunometabolic Changes of Perivascular Adipose Tissue

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT07360925
Acronym
AdipoCor
Enrollment
60
Registered
2026-01-22
Start date
2023-06-01
Completion date
2029-07-01
Last updated
2026-01-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Heart Failure, Heart Transplantation

Keywords

Pericoronary adipose tissue, adipocyte size, inflammatory changes, macrophages

Brief summary

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

PROCEDUREHeart 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.

Sponsors

Institute for Clinical and Experimental Medicine
Lead SponsorOTHER_GOV

Study design

Observational model
OTHER
Time perspective
CROSS_SECTIONAL

Eligibility

Sex/Gender
ALL
Age
30 Years to 90 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Adipocyte sizePerioperative/PeriproceduralAssessment 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

Secondary

MeasureTime frameDescription
Immunological parametersPerioperative/PeriproceduralThe 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.
Morphological parametersPerioperative/PeriproceduralThe morphological characteristics-atherosclerotic plaque type (category) and calcification rate (percentage)-in the arterial wall and pericoronary adipose tissue (PCAT) will be analyzed and compared.

Countries

Czechia

Contacts

CONTACTIvana K Lesna, MD, PhD., assoc. prof.
ivana.kralova.lesna@ikem.cz00420236055445
CONTACTPeter Ivak, M.D., PhD, assoc. prof.
peter.ivak@ikem.cz

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026