Pericoronary Adipocyte Size Gradient (AdipoCor)

January 14, 2026 updated by: Ivana Kralova Lesna, Institute for Clinical and Experimental Medicine

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

Evaluation of pericoronary adipocyte gradient (PCAT) in relationship with local atherosclerotic changes in a patient undergoing heart transplantation.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Estimated)

60

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Czechia
      • Prague, Czechia, 14021
        • Recruiting
        • Centre of Experimental Medicine, Institute for Clinical and Experimental Medicine,

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study 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.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
patients with advanced heart failure
A group of patients with advanced heart failure were indicated for heart transplanta-tion for either ischemic or dilatational cardiomyopathy. The study group will also in-clude subjects with previously implanted LVAD as a bridge-to-transplant approach. Predictory-related subgroups will be evaluated separately.
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Adipocyte size
Time Frame: Perioperative/Periprocedural
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
Perioperative/Periprocedural

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Immunological parameters
Time Frame: Perioperative/Periprocedural
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.
Perioperative/Periprocedural
Morphological parameters
Time Frame: Perioperative/Periprocedural
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.
Perioperative/Periprocedural

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Institute for Clinical and Experimental Medicine

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 1, 2023

Primary Completion (Estimated)

July 1, 2028

Study Completion (Estimated)

July 1, 2029

Study Registration Dates

First Submitted

January 6, 2026

First Submitted That Met QC Criteria

January 14, 2026

First Posted (Actual)

January 22, 2026

Study Record Updates

Last Update Posted (Actual)

January 22, 2026

Last Update Submitted That Met QC Criteria

January 14, 2026

Last Verified

January 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AdipoCor2023

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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