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
|Condition or disease||Intervention/treatment|
|Coronary Artery Disease Coronary Arteriosclerosis Atrial Fibrillation Left Atrial Abnormality Severe Aortic Stenosis||Other: Aortic valve replacement|
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 Type :||Observational|
|Estimated Enrollment :||500 participants|
|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|
- 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
- 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
- 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
- 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
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Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03280433
|Contact: Jennifer Mancio, MD, PhD email@example.com|
|Contact: Nuno Bettencourt, MD, PhDfirstname.lastname@example.org|
|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 email@example.com|
|Contact: Nuno Bettencourt, MD, PhD 00351 934258281 firstname.lastname@example.org|
|Sub-Investigator: Vasco Gama Ribeiro, MD|
|Sub-Investigator: Luis Vouga, MD|
|Faculty of Medicine of Porto||Enrolling by invitation|
|Porto, Portugal, 4200-319|