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Influence of EPICardial Adipose Tissue in HEART Diseases: EPICHEART Study (EPICHEART)

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ClinicalTrials.gov Identifier: NCT03280433
Recruitment Status : Unknown
Verified September 2017 by Jennifer Mancio, Centro Hospitalar de Vila Nova de Gaia/Espinho, E.P.E..
Recruitment status was:  Recruiting
First Posted : September 12, 2017
Last Update Posted : September 14, 2017
Sponsor:
Collaborator:
Universidade do Porto
Information provided by (Responsible Party):
Jennifer Mancio, Centro Hospitalar de Vila Nova de Gaia/Espinho, E.P.E.

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.

Condition or disease Intervention/treatment
Coronary Artery Disease Coronary Arteriosclerosis Atrial Fibrillation Left Atrial Abnormality Severe Aortic Stenosis Other: Aortic valve replacement

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.

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Study Type : Observational
Estimated Enrollment : 500 participants
Observational Model: Cohort
Time Perspective: Prospective
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
Actual Study Start Date : September 1, 2014
Actual Primary Completion Date : November 25, 2015
Estimated Study Completion Date : November 25, 2018





Primary Outcome Measures :
  1. 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

  2. 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

  3. Frailty syndrome according to Fried et al. scale [ Time Frame: 6-month following aortic valve replacement ]
    Change in frailty syndrome classification

  4. Coronary artery disease according to the presence of coronary stenosis and/or calcification [ Time Frame: Baseline ]
    Prevalent coronary artery stenosis and coronary calcification


Secondary Outcome Measures :
  1. Left ventricular hypertrophy by transthoracic echocardiography and magnetic resonance imaging [ Time Frame: 6-month following aortic valve replacement ]
    Regression of left ventricular mass after aortic valve replacement

  2. Right ventricular structure and function by transthoracic echocardiography and magnetic resonance imaging [ Time Frame: 6-month following aortic valve replacement ]
    Changes in right ventricular structure and function after aortic valve replacement


Other Outcome Measures:
  1. Mortality [ Time Frame: 3- to 5-year after aortic valve replacement ]
    Incidence of all-cause death after aortic valve replacement


Biospecimen Retention:   Samples With DNA
Fat samples (Epicardial fat, mediastinal fat, and subcutaneous fat), blood samples, pericardial fluid samples, right atrial appendage sample.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Symptomatic severe aortic stenosis referred to aortic valve replacement.
Criteria

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03280433


Contacts
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Contact: Jennifer Mancio, MD, PhD candidate 00351961529516 jennifer.mancio@cardiov.ox.ac.uk
Contact: Nuno Bettencourt, MD, PhD 00351934258281 bettencourt.n@gmail.com

Locations
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Portugal
Centro Hospitalar de Vila Nova de Gaia/Espinho Recruiting
Vila Nova de Gaia, Porto, Portugal, 4430-502
Contact: Jennifer Mancio, MD, PhD candidate    00351 961529516    jennifer.mancio@cardiov.ox.ac.uk   
Contact: Nuno Bettencourt, MD, PhD    00351 934258281    bettencourt.n@gmail.com   
Sub-Investigator: Vasco Gama Ribeiro, MD         
Sub-Investigator: Luis Vouga, MD         
Faculty of Medicine of Porto Enrolling by invitation
Porto, Portugal, 4200-319
Sponsors and Collaborators
Centro Hospitalar de Vila Nova de Gaia/Espinho, E.P.E.
Universidade do Porto
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Responsible Party: Jennifer Mancio, Principal Investigator, Centro Hospitalar de Vila Nova de Gaia/Espinho, E.P.E.
ClinicalTrials.gov Identifier: NCT03280433    
Other Study ID Numbers: SFRH/BD/104369/2014
First Posted: September 12, 2017    Key Record Dates
Last Update Posted: September 14, 2017
Last Verified: September 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Jennifer Mancio, Centro Hospitalar de Vila Nova de Gaia/Espinho, E.P.E.:
Epicardial adipose tissue
Coronary artery disease
Atrial fibrillation
Severe aortic stenosis
Proteome
Mass spectrometry
Computed tomography
Additional relevant MeSH terms:
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Atrial Fibrillation
Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Aortic Valve Stenosis
Arteriosclerosis
Constriction, Pathologic
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes
Arterial Occlusive Diseases
Vascular Diseases
Pathological Conditions, Anatomical
Heart Valve Diseases
Ventricular Outflow Obstruction