Ignite Creation Date:
2024-05-06 @ 10:31 AM
Last Modification Date:
2024-10-26 @ 12:31 PM
Study NCT ID:
NCT03280433
Status:
UNKNOWN
Last Update Posted:
2017-09-14
First Post:
2017-09-08
Brief Title:
Influence of EPICardial Adipose Tissue in HEART Diseases EPICHEART Study
Sponsor:
Centro Hospitalar de Vila Nova de GaiaEspinho EPE
Organization:
Centro Hospitalar de Vila Nova de GaiaEspinho EPE
Study Overview
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
Status:
UNKNOWN
Status Verified Date:
2017-09
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
EPICHEART
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
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
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None