Mapping fat-cell sizes around the coronary arteries to trace inflammation
Direct Measurement of Pericoronary Adipocyte Size Gradient as a Parameter of Immunometabolic Changes of Perivascular Adipose Tissue
Institute for Clinical and Experimental Medicine · NCT07360925
This project will test whether differences in fat-cell size next to the coronary arteries can show how inflammation spreads in people having a heart transplant for advanced heart failure.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 60 (estimated) |
| Ages | 30 Years to 90 Years |
| Sex | All |
| Sponsor | Institute for Clinical and Experimental Medicine (other gov) |
| Locations | 1 site (Prague) |
| Trial ID | NCT07360925 on ClinicalTrials.gov |
What this trial studies
Researchers will collect explanted hearts during heart transplantation at IKEM from patients with ischemic or dilated cardiomyopathy. Pericoronary adipose tissue samples close to and farther from the arterial lumen will be analyzed for adipocyte size, immunometabolic markers, and macrophage changes to create spatial gradients. Clinical data including age, BMI, comorbidities, medications and prior LVAD use will be recorded to relate tissue findings to patient context and altered coronary flow. Results will compare patients with advanced atherosclerosis to those with less atherosclerotic disease to determine patterns of local inflammation propagation.
Who should consider this trial
Good fit: Adults aged 30–90 with a diagnosis of dilated or ischemic cardiomyopathy who are undergoing heart transplantation at IKEM and can give informed consent.
Not a fit: Patients with combined dilated and ischemic cardiomyopathy, arrhythmogenic cardiomyopathy, congenital heart defects, those not undergoing transplantation at IKEM, or those unable to consent are unlikely to benefit from this project.
Why it matters
Potential benefit: If successful, this could reveal how local fat inflammation contributes to coronary artery disease and point to new targets for prevention or treatment.
How similar studies have performed: Previous research has linked pericoronary adipose inflammation to coronary disease, but direct mapping of adipocyte-size gradients in explanted human hearts is a relatively novel approach.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Prague
- Centre of Experimental Medicine, Institute for Clinical and Experimental Medicine, — Prague, Czechia (RECRUITING)
Study contacts
- Study coordinator: Ivana K Lesna, MD, PhD., assoc. prof.
- Email: ivana.kralova.lesna@ikem.cz
- Phone: 00420236055445
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Heart Failure, Heart Transplantation, Pericoronary adipose tissue, adipocyte size, inflammatory changes, macrophages