Epicardial Fat TissueNCT04111198
Epicardial Fat Tissue and Severity of Coronary Artery Disease in Diabetic vs Non Diabetic Patients
An observational study of Epicardial Fat Tissue, run by Bakeer Mohamed Bakeer.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Epicardial Fat Tissue
- What is being tested?
- Cardiac MRI
- Type of treatment
- Surgery or procedure
- How many people
- 80 participants
- Where
- No sites listed yet
- Study dates
- 1 Dec 2019to 1 Mar 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients presenting for cardiac MRI unit in Assiut University Hospital for viability assessment.
Who may be able to join
- Age over 18 years
- Patients presenting for cardiac MRI unit in Assiut University Hospital for viability assessment.
- Having diagnostic coronary angiography done or to be done within a 3 months of the cardiac MRI study
Who cannot join
- patients not having CA within the aforementioned time limits. Other classical contraindications of cardiac MRI including: MRI non-conditional devices, claustrophobia and eGFR> 30 ml/sec/1.73 m2 BSA. (NB. Gadolinium is not required for EFT measurement but for the viability study of the patients.)
Trial locations and contacts
No sites are listed yet.
About this study
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.
Read the 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 heart's 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.
- Conditions
- Epicardial Fat Tissue
- Being tested
- Cardiac MRI
- Keywords
- Epicardial fat tissue, Cardiac MRI, Coronary Artery disease
- Medical subject headings
- Coronary Artery Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cardiac MRIRadiation
Cardiac MRI
| Study group | Role | What they receive |
|---|---|---|
| coronary artery disease in diabetic and non diabetic patients | Not described Receives: Radiation: Cardiac MRI |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 30 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Oct 2019
- Study start1 Dec 2019 (estimated)
- Primary completion1 Mar 2022 (estimated)
- Study completion1 Mar 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Epicardial Fat TissueStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Bakeer Mohamed Bakeer
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Bakeer Mohamed Bakeer, Assiut University
- Investigators
- Bakeer Mohamed Bakeer, MSC, Principal investigator, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04111198
- Sponsor's protocol ID
- Epicardial fat tissue
- Status last verified
- Sep 2019
- First submitted
- 29 Sep 2019
- Last updated
- 1 Oct 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Epicardial Fat Tissue and Severity of Coronary Artery Disease in Diabetic vs Non Diabetic Patients
- ClinicalTrials.gov ID
- NCT04111198
- Acronym / sponsor ID
- Epicardial fat tissue
- Conditions
- Epicardial Fat Tissue
- Keywords
- Epicardial fat tissue, Cardiac MRI, Coronary Artery disease
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Bakeer Mohamed BakeerUniversity, hospital or other
- Study start
- 1 Dec 2019 (estimated)
- Primary completion
- 1 Mar 2022 (estimated)
- Study completion
- 1 Mar 2023 (estimated)
- First posted
- 1 Oct 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 heart's 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 design
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| coronary artery disease in diabetic and non diabetic patients | – | Radiation: Cardiac MRI |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients presenting for cardiac MRI unit in Assiut University Hospital for viability assessment.
Key inclusion criteria (3 listed)
- Age over 18 years
- Patients presenting for cardiac MRI unit in Assiut University Hospital for viability assessment.
- Having diagnostic coronary angiography done or to be done within a 3 months of the cardiac MRI study
Key exclusion criteria (1 listed)
- patients not having CA within the aforementioned time limits. Other classical contraindications of cardiac MRI including: MRI non-conditional devices, claustrophobia and eGFR> 30 ml/sec/1.73 m2 BSA. (NB. Gadolinium is not required for EFT measurement but for the viability study of the patients.)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cardiac MRICardiac MRI | Radiation | coronary artery disease in diabetic and non diabetic patients |
Primary outcome
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
Time frame: 30 minutes
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Oct 2019.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Bakeer Mohamed Bakeer, MSC principal investigator
Assiut University
Questions about this trial
What is this clinical trial studying?
An observational study of Epicardial Fat Tissue, run by Bakeer Mohamed Bakeer.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 1 Oct 2019. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Hatem Abd Elrhman Helmy, Professor (01005212162 ext. +20, hatem19652007@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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 (time frame: 30 minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Oct 2019.