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NCT Number: NCT07360925

Pericoronary Adipocyte Size Gradient

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

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Key information

Conditions

Heart Failure Cardiovascular Diseases Heart Diseases Heart Transplantation

Age range

30 year–90 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Centre of Experimental Medicine, Institute for Clinical and Experimental Medicine,

Prague, 14021, Czechia

Location status: Recruiting

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Heart transplantation for the final stage of heart failure

Procedure

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 outcomes

  1. 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

Secondary outcomes

  1. 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.

  2. 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Ivana K Lesna, MD, PhD., assoc. prof.

CONTACT

[email protected]

00420236055445

Peter Ivak, M.D., PhD, assoc. prof.

CONTACT

[email protected]

Sponsors and collaborators

Lead sponsor

Institute for Clinical and Experimental Medicine

Other Gov

Registry information

Official study title

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

Acronym: AdipoCor

Important dates

Study start
2023
Primary completion
2028
Study completion
2029
First posted
Jan 22, 2026
Registry last updated
Jan 22, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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