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

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
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

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
June 1, 2023

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
July 1, 2028

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
July 1, 2029

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 6, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 14, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
January 22, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
January 22, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 14, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
January 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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