Viewing Study NCT04111198



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Last Modification Date: 2024-10-26 @ 1:19 PM
Study NCT ID: NCT04111198
Status: UNKNOWN
Last Update Posted: 2019-10-01
First Post: 2019-09-29

Brief Title: Epicardial Fat Tissue and Severity of Coronary Artery Disease in Diabetic vs Non Diabetic Patients
Sponsor: Bakeer Mohamed Bakeer
Organization: Assiut University

Study Overview

Official Title: Epicardial Fat Tissue and Severity of Coronary Artery Disease in Diabetic vs Non Diabetic Patients
Status: UNKNOWN
Status Verified Date: 2019-09
Last Known Status: NOT_YET_RECRUITING
Delayed Posting: No
If Stopped, Why?: Not Stopped
Has Expanded Access: False
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: None
Brief Summary: correlation between EFT volume measured by Cardiac MRI and the angiographic severity of coronary artery disease Syntax Score in diabetic vs non diabetic CAD population and detect if there is a cut off value for each group that could predict higher risk
Detailed Description: Epicardial fat tissue EFT is is most commonly defined as adipose tissue surrounding the heart located between the myocardium and the visceral layer of pericardium Once considered only as a mere storage compartment the adipose tissue is now recognized for its extensive metabolic and endocrine function EFT is a storage fat that covers 80 of the hearts surface representing 20 of the organ total weight EFT is considered to be a part of visceral adipose tissue This fat is a major source of biomolecules and compartmentalized production of cytokines and hormones acting as a localized gland

Moreover EFT and the underlying myocardium share the same microcirculation suggesting a close and strong interaction between these two structures it regulates heart and blood vessel physiologically via paracrine and vasocrine mechanisms It has also been reported that EFT acts as important energy reservoir for cardiomyocytes which depend on fatty acids oxidations as energy source especially during periods of high demand

Although EFT is needed for heart muscle function in recent decades it has been published that increased thickness greatly enhances the risk of developing CVD and metabolic syndrome becoming a new pharmacological target for primary and secondary prevention strategies Therefore the measurement of epicardial fat deposition is important In terms of modulation the use of statins could function as a possible treatment to help decrease the volume of EFT beside stabilization of atherosclerotic plaques

Detection and quantification of EFT require a variety of useful imaging techniques including 2-dimensional 2D echocardiography non-contrast computed tomography CT and magnetic resonance imaging MRI Since fat tissue generates a strong MRI signal both thickness and volume of epicardial fat can be easily measured with this modality

Clinical research found that it was related to coronary artery disease where it was found to be independently and linearly associated with CAD and its severity atrial fibrillation as well as myocardial dysfunction

It is known that abnormally accumulated visceral fat is a risk factor for insulin resistance which can reduce insulin sensitivity increase the expression and secretion of proinflammatory cytokines in adipose tissue and promote the development of DM and cardiovascular diseases Since EFT is a part of the visceral fat it carries that risk

Regarding relation to CAD in DM there have been conflicting data

Maniam et al reported that EFT was higher in non-diabetics with CVD but not in T2DM with or without CVD This suggests EFT may play a greater role in CVD in non-diabetics than those with T2DM

However in the past few years several other studies have reported that EFT is abnormally increased in DM patients However small sample sizes and potential confounders such as differences in EFT measurements and DM typing were thought to affect the strength of previous evidence

A metanalysis conducted suggests that the amount of EFT is significantly higher in DM patients than in non-DM patients

Another study addressing mainly type 1 DM found that Long-term survivors of T1DM have a higher prevalence of coronary atherosclerosis compared to controls but EFT volume was not associated with coronary atherosclerosis in T1DM patients

Study Oversight

Has Oversight DMC: None
Is a FDA Regulated Drug?: False
Is a FDA Regulated Device?: False
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: None
Is an FDA AA801 Violation?: None