An observational study in Coronary Artery Disease, Coronary Arteriosclerosis and Atrial Fibrillation, sponsored by Centro Hospitalar de Vila Nova de Gaia/Espinho, E.P.E.. Status unknown at 2 sites in Portugal. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2017-09-14.
Sponsored by Centro Hospitalar de Vila Nova de Gaia/Espinho, E.P.E. · Observational
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.
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.
5,676 studies on the registry are indexed under Coronary Artery Disease; 958 are open to participants now.
This study's planned enrollment of 500 is above the median of 335 across 1,978 observational studies indexed under Coronary Artery Disease.
Browse Coronary Artery Disease studies →Centro Hospitalar de Vila Nova de Gaia/Espinho, E.P.E. is the lead sponsor of 7 studies on the registry; 2 are open to participants now.
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Symptomatic severe aortic stenosis referred to aortic valve replacement.
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Exclusion Criteria:
New onset atrial fibrillation
Incidence of atrial fibrillation after aortic valve replacement
Time frame: 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
Time frame: 6-month following aortic valve replacement
Frailty syndrome according to Fried et al. scale
Change in frailty syndrome classification
Time frame: 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
Time frame: Baseline
Left ventricular hypertrophy by transthoracic echocardiography and magnetic resonance imaging
Regression of left ventricular mass after aortic valve replacement
Time frame: 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
Time frame: 6-month following aortic valve replacement
Mortality
Incidence of all-cause death after aortic valve replacement
Time frame: 3- to 5-year after aortic valve replacement
Plan to share: No
This study is status unknown, as verified in Sep 2017. You cannot join it, but the record below documents what was studied.
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Centro Hospitalar de Vila Nova de Gaia/Espinho, E.P.E.