EPICHEART
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
Sponsor study identifier
observational
500
1 country
2
Study Start
September 1, 2014
Actual (reported)Primary Completion
November 25, 2015
Actual (reported)Study Completion
November 25, 2018
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
November 25, 2018
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
September 1, 2014
Actual (reported)November 25, 2015
Actual (reported)September 8, 2017
Actual (reported)September 12, 2017
Actual (reported)November 25, 2018
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
New onset atrial fibrillation
Incidence of atrial fibrillation after aortic valve replacement
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
6-month following aortic valve replacement
Frailty syndrome according to Fried et al. scale
Change in frailty syndrome classification
6-month following aortic valve replacement
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Symptomatic severe aortic stenosis referred to aortic valve replacement.
Centro Hospitalar de Vila Nova de Gaia/Espinho
Vila Nova de Gaia, Porto District, 4430-502, Portugal
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.
Fat samples (Epicardial fat, mediastinal fat, and subcutaneous fat), blood samples, pericardial fluid samples, right atrial appendage sample.
First Submitted
September 8, 2017
First Posted
September 12, 2017
Study Start
September 1, 2014
Actual (reported)Primary Completion
November 25, 2015
Actual (reported)Prospective European Multicenter Study on Aortic Valve Replacement: (E-AVR Registry)
Coronary artery disease according to the presence of coronary stenosis and/or calcification
Prevalent coronary artery stenosis and coronary calcification
Baseline
Left ventricular hypertrophy by transthoracic echocardiography and magnetic resonance imaging
6-month following aortic valve replacement
Right ventricular structure and function by transthoracic echocardiography and magnetic resonance imaging
6-month following aortic valve replacement
Mortality
3- to 5-year after aortic valve replacement
Contact the study team to confirm eligibility.
Faculty of Medicine of Porto
Porto, 4200-319, Portugal
Study Completion
November 25, 2018
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Last Updated
September 14, 2017
Record last verified: 2017-09
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Source: ClinicalTrials.gov.
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