Coronary Artery DiseaseEPICHEARTNCT03280433
Influence of EPICardial Adipose Tissue in HEART Diseases: EPICHEART Study
An observational study of Coronary Artery Disease and Coronary Arteriosclerosis, run by Centro Hospitalar de Vila Nova de Gaia/Espinho, E.P.E. at 2 sites in Portugal.
Trial summary
This translational study was designed to explore the association of the quantity and quality of epicardial adipose tissue (EAT) with coronary artery disease (CAD), left atrial remodeling and postoperative atrial fibrillation in a high cardiovascular disease-risk population. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Coronary Artery Disease, Coronary Arteriosclerosis, Atrial Fibrillation
- What is being tested?
- Aortic valve replacement
- How many people
- 500 participants
- Where
- 2 sitesPortugal
- Study dates
- 1 Sep 2014to 25 Nov 2018
- 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: Symptomatic severe aortic stenosis referred to aortic valve replacement.
Who may be able to join
- symptomatic severe aortic stenosis patients (defined as aortic valve area of < 1 cm2 or 0.6 cm2/m2 by transthoracic echocardiography) referred to aortic valve replacement.
Who cannot join
- diagnosis of acute coronary syndrome in the last 3 months.
- prior history of persistent or permanent atrial or flutter fibrillation.
- coexisting moderate to severe aortic valve regurgitation or moderate to severe mitral valve disease, bicuspid aortic valve.
- left ventricular dilatation [end-diastolic volume index >75 mL/m²].
- left ventricular ejection fraction <55%.
- chronic renal failure stage 3 to 5 defined as glomerular filtration rate GFR estimated by Cockcroft-Gault formula adjusted for body surface area < 30 mL/min/1.73m².
- moderate to severe chronic obstructive pulmonary disease defined as forced expiratory volume in one second <50% according to the 2011 Global Initiative for Chronic Obstructive Pulmonary Disease guidelines.
- active malignancy (i.e. With no evidence of recurrence and no longer receiving active treatment).
Trial locations and contacts
2 sites in 1 country.
Portugal2 sites, 2 recruiting
- Enrolling by invitation
Faculty of Medicine of Porto
Porto, 4200-319
- Recruiting
Centro Hospitalar de Vila Nova de Gaia/Espinho
Vila Nova de Gaia, Porto District, 4430-502
Jennifer Mancio, MD, PhD candidate, 00351 961529516, jennifer.mancio@cardiov.ox.ac.uk
Nuno Bettencourt, MD, PhD, 00351 934258281, bettencourt.n@gmail.com
About this study
Official title: Association of the Volume and Proteome of Epicardial Adipose Tissue With Coronary Artery Disease, Left Atrial Remodelling and Atrial Fibrillation in Severe Aortic Stenosis Patients
This translational study was designed to explore the association of the quantity and quality of epicardial adipose tissue (EAT) with coronary artery disease (CAD), left atrial remodeling and postoperative atrial fibrillation in a high cardiovascular disease-risk population. The investigators expect to identify new biochemical factors and biomarkers in the crosstalk between the epicardial adipocytes, coronary plaques and atrial cardiomyocytes that are involved in the pathogenesis of atherosclerosis and atrial fibrillation, respectively.
Read the detailed description
Background: EAT has emerged as a new independent, and, potentially, modifiable cardiovascular risk factor for CAD. EAT volume assessed by computed tomography (CT) was independently associated with the presence of coronary stenosis, coronary calcification and myocardial ischemia in cross-sectional studies, and, prospectively, with major adverse cardiovascular events. Most of these clinical studies were, however, derived from community-based patients with low-to intermediate-risk profile and the role of EAT in high-risk patients is currently unclear. Accumulation of EAT has been also associated with left atrial (LA) dilation, presence, chronicity, and recurrence of atrial fibrillation (AF). Although there is evidence suggesting that EAT may be a major determinant of the LA vulnerable substrate of AF, the mechanisms in the causal pathway between the EAT and LA remodeling are not completely elucidated.
Aims: The main aims are to investigate if the volume of the EAT on CT and EAT proteome assessed by SWATH-mass spectrometry are associated with extent, distribution and complexity of coronary stenosis and coronary artery calcification, left atrial strain and incidence of postoperative atrial fibrillation in patients with symptomatic severe aortic stenosis.
Methods: This a prospective study enrolling symptomatic severe aortic stenosis patients referred to aortic valve replacement. The protocol includes preoperative detailed clinical and nutritional evaluations, echocardiography, CT, cardiac magnetic resonance imaging and invasive coronary angiography. During cardiac surgery, biopsies from the EAT, mediastinal and subcutaneous thoracic adipose tissues will be performed to undergo analysis of proteome using SWAT-mass spectrometry. Samples from the pericardial fluid, circulating and coronary sinus blood samples will be collected as well in order to find local and peripheral adipose tissue-derived biomarkers of the disease.
- Conditions
- Coronary Artery Disease, Coronary Arteriosclerosis, Atrial Fibrillation, Left Atrial Abnormality, Severe Aortic Stenosis
- Being tested
- Aortic valve replacement
- Keywords
- Epicardial adipose tissue, Coronary artery disease, Atrial fibrillation, Severe aortic stenosis, Proteome, Mass spectrometry, Computed tomography
- Medical subject headings
- Coronary Artery Disease, Atrial Fibrillation, Aortic Valve Stenosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Aortic valve replacementOther
What is being measured
The primary outcome is the main question the study is designed to answer.
New onset atrial fibrillation
Incidence of atrial fibrillation after aortic valve replacement
Measured: Intra-hospital (i.e. from surgery until hospital discharge which means 7 days on average)
Left atrial remodelling by transthoracic echocardiography and magnetic resonance imaging
Change in left atrial strain and volumes
Measured: 6-month following aortic valve replacement
Frailty syndrome according to Fried et al. scale
Change in frailty syndrome classification
Measured: 6-month following aortic valve replacement
Coronary artery disease according to the presence of coronary stenosis and/or calcification
Prevalent coronary artery stenosis and coronary calcification
Measured: Baseline
Secondary outcomes (2)
Left ventricular hypertrophy by transthoracic echocardiography and magnetic resonance imaging
Regression of left ventricular mass after aortic valve replacement
Measured: 6-month following aortic valve replacement
Right ventricular structure and function by transthoracic echocardiography and magnetic resonance imaging
Changes in right ventricular structure and function after aortic valve replacement
Measured: 6-month following aortic valve replacement
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Sep 2017
- Study start1 Sep 2014
- Primary completion25 Nov 2015
- Study completion25 Nov 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Coronary Artery DiseaseStudies 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centro Hospitalar de Vila Nova de Gaia/Espinho, E.P.E.
- Sponsor type
- Other government
- Collaborators
- Universidade do Porto
- Responsible party
- Principal investigator, Jennifer Mancio, Centro Hospitalar de Vila Nova de Gaia/Espinho, E.P.E.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03280433
- Sponsor's protocol ID
- SFRH/BD/104369/2014
- Acronym
- EPICHEART
- Status last verified
- Sep 2017
- First submitted
- 8 Sep 2017
- Last updated
- 14 Sep 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Baeza R, Nunes F, Santos C, Mancio J, Fontes-Carvalho R, Renna F, Pedrosa J. Validation of a deep learning approach for epicardial adipose tissue segmentation in computed tomography. Int J Cardiovasc Imaging. 2026 Mar;42(3):551-559. doi: 10.1007/s10554-025-03528-1. Epub 2025 Nov 13.
PubMed 41233698
Study at a glance
From the registry record, last updated by the sponsor on 14 Sep 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Association of the Volume and Proteome of Epicardial Adipose Tissue With Coronary Artery Disease, Left Atrial Remodelling and Atrial Fibrillation in Severe Aortic Stenosis Patients
- ClinicalTrials.gov ID
- NCT03280433
- Acronym / sponsor ID
- EPICHEART / SFRH/BD/104369/2014
- Conditions
- Coronary Artery Disease, Coronary Arteriosclerosis, Atrial Fibrillation, Left Atrial Abnormality, Severe Aortic Stenosis
- Keywords
- Epicardial adipose tissue, Coronary artery disease, Atrial fibrillation, Severe aortic stenosis, Proteome, Mass spectrometry, Computed tomography
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- Centro Hospitalar de Vila Nova de Gaia/Espinho, E.P.E.Other government
- Collaborators
- Universidade do Porto
- Study start
- 1 Sep 2014 (actual)
- Primary completion
- 25 Nov 2015 (actual)
- Study completion
- 25 Nov 2018 (estimated)
- First posted
- 12 Sep 2017 (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.
This translational study was designed to explore the association of the quantity and quality of epicardial adipose tissue (EAT) with coronary artery disease (CAD), left atrial remodeling and postoperative atrial fibrillation in a high cardiovascular disease-risk population. The investigators expect to identify new biochemical factors and biomarkers in the crosstalk between the epicardial adipocytes, coronary plaques and atrial cardiomyocytes that are involved in the pathogenesis of atherosclerosis and atrial fibrillation, respectively.
Detailed description
Background: EAT has emerged as a new independent, and, potentially, modifiable cardiovascular risk factor for CAD. EAT volume assessed by computed tomography (CT) was independently associated with the presence of coronary stenosis, coronary calcification and myocardial ischemia in cross-sectional studies, and, prospectively, with major adverse cardiovascular events. Most of these clinical studies were, however, derived from community-based patients with low-to intermediate-risk profile and the role of EAT in high-risk patients is currently unclear. Accumulation of EAT has been also associated with left atrial (LA) dilation, presence, chronicity, and recurrence of atrial fibrillation (AF). Although there is evidence suggesting that EAT may be a major determinant of the LA vulnerable substrate of AF, the mechanisms in the causal pathway between the EAT and LA remodeling are not completely elucidated.
Aims: The main aims are to investigate if the volume of the EAT on CT and EAT proteome assessed by SWATH-mass spectrometry are associated with extent, distribution and complexity of coronary stenosis and coronary artery calcification, left atrial strain and incidence of postoperative atrial fibrillation in patients with symptomatic severe aortic stenosis.
Methods: This a prospective study enrolling symptomatic severe aortic stenosis patients referred to aortic valve replacement. The protocol includes preoperative detailed clinical and nutritional evaluations, echocardiography, CT, cardiac magnetic resonance imaging and invasive coronary angiography. During cardiac surgery, biopsies from the EAT, mediastinal and subcutaneous thoracic adipose tissues will be performed to undergo analysis of proteome using SWAT-mass spectrometry. Samples from the pericardial fluid, circulating and coronary sinus blood samples will be collected as well in order to find local and peripheral adipose tissue-derived biomarkers of the disease.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Symptomatic severe aortic stenosis referred to aortic valve replacement.
Key inclusion criteria (1 listed)
- symptomatic severe aortic stenosis patients (defined as aortic valve area of < 1 cm2 or 0.6 cm2/m2 by transthoracic echocardiography) referred to aortic valve replacement.
Key exclusion criteria (8 listed)
- diagnosis of acute coronary syndrome in the last 3 months.
- prior history of persistent or permanent atrial or flutter fibrillation.
- coexisting moderate to severe aortic valve regurgitation or moderate to severe mitral valve disease, bicuspid aortic valve.
- left ventricular dilatation [end-diastolic volume index >75 mL/m²].
- left ventricular ejection fraction <55%.
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 |
|---|---|---|
| Aortic valve replacement | Other | – |
Primary outcome
New onset atrial fibrillation
Time frame: Intra-hospital (i.e. from surgery until hospital discharge which means 7 days on average)
Incidence of atrial fibrillation after aortic valve replacement
Left atrial remodelling by transthoracic echocardiography and magnetic resonance imaging
Time frame: 6-month following aortic valve replacement
Change in left atrial strain and volumes
Frailty syndrome according to Fried et al. scale
Time frame: 6-month following aortic valve replacement
Change in frailty syndrome classification
Coronary artery disease according to the presence of coronary stenosis and/or calcification
Time frame: Baseline
Prevalent coronary artery stenosis and coronary calcification
2 secondary outcomes
Left ventricular hypertrophy by transthoracic echocardiography and magnetic resonance imaging
Time frame: 6-month following aortic valve replacement
Right ventricular structure and function by transthoracic echocardiography and magnetic resonance imaging
Time frame: 6-month following aortic valve replacement
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Sep 2017.
- Derived from this study: PubMed 41233698Baeza R, Nunes F, Santos C, Mancio J, Fontes-Carvalho R, Renna F, Pedrosa J. Validation of a deep learning approach for epicardial adipose tissue segmentation in computed tomography. Int J Cardiovasc Imaging. 2026 Mar;42(3):551-559. doi: 10.1007/s10554-025-03528-1. Epub 2025 Nov 13.
- Individual participant dataSharing planned: No
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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.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Coronary Artery Disease and Coronary Arteriosclerosis, run by Centro Hospitalar de Vila Nova de Gaia/Espinho, E.P.E. at 2 sites in Portugal.
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 1 inclusion and 8 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 14 Sep 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Portugal. Whether a site is taking part right now should be confirmed with that site. See every site.
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 Jennifer Mancio, MD, PhD candidate (00351961529516, jennifer.mancio@cardiov.ox.ac.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
New onset atrial fibrillation (time frame: Intra-hospital (i.e. from surgery until hospital discharge which means 7 days on average)). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03280433, which also lists 1 linked publication.
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 14 Sep 2017.