Influence of EPICardial Adipose Tissue in HEART Diseases: EPICHEART Study

NCT03280433 | Unknown

• 1 other identifier: SFRH/BD/104369/2014
• Study Type: observational
• Target: 500
• Locations: 1 country
• Sites: 2

Brief 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. 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.

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

Outcome Measures

Primary Outcomes (4)

• 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

• Coronary artery disease according to the presence of coronary stenosis and/or calcification

  Prevalent coronary artery stenosis and coronary calcification

  Baseline

Secondary Outcomes (2)

• 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

Other Outcomes (1)

• Mortality

  3- to 5-year after aortic valve replacement

Interventions

Aortic valve replacement OTHER

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Symptomatic severe aortic stenosis referred to aortic valve replacement.

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• Centro Hospitalar de Vila Nova de Gaia/Espinho, E.P.E.: lead
• Universidade do Porto: collaborator

Study Sites (2)

Centro Hospitalar de Vila Nova de Gaia/Espinho

Vila Nova de Gaia, Porto District, 4430-502, Portugal

RECRUITING

Faculty of Medicine of Porto

Porto, 4200-319, Portugal

ENROLLING BY INVITATION

Related Publications (1)

• 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. 2025 Nov 13. doi: 10.1007/s10554-025-03528-1. Online ahead of print.

  PMID: 41233698 DERIVED

Biospecimen

Retention: SAMPLES WITH DNA

Fat samples (Epicardial fat, mediastinal fat, and subcutaneous fat), blood samples, pericardial fluid samples, right atrial appendage sample.

MeSH Terms

Conditions

Coronary Artery Disease; Atrial Fibrillation; Aortic Valve Stenosis

Interventions

Transcatheter Aortic Valve Replacement

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Arrhythmias, Cardiac; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Aortic Valve Disease; Heart Valve Diseases; Ventricular Outflow Obstruction

Intervention Hierarchy (Ancestors)

Heart Valve Prosthesis Implantation; Cardiac Surgical Procedures; Cardiovascular Surgical Procedures; Surgical Procedures, Operative; Prosthesis Implantation; Thoracic Surgical Procedures

Central Study Contacts

Jennifer Mancio, MD, PhD candidate

CONTACT

00351961529516; jennifer.mancio@cardiov.ox.ac.uk

Nuno Bettencourt, MD, PhD

CONTACT

00351934258281; bettencourt.n@gmail.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: September 8, 2017
• First Posted: September 12, 2017
• Study Start: September 1, 2014
• Primary Completion: November 25, 2015
• Study Completion: November 25, 2018
• Last Updated: September 14, 2017

Record last verified: 2017-09

Data Sharing

• IPD Sharing: Will not share

Locations

PT (2)