Influence of EPICardial Adipose Tissue in HEART Diseases: EPICHEART Study

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Aortic valve stenosis
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A Retrospective Registry Study ROUTE Registry Of the Utilisation of the Transaortic (Tao) TAVI Approach Using the Edwards Sapien XT Valve The Medtronic CoreValve™ Evolut R™ CE Mark Clinical Study Microembolic Signals and Cerebrospinal Fluid Markers of Neuronal Damage After Surgical Aortic Valve Replacement Direct Aortic vs Subclavian Access for TAVI: a Review of the Outcomes in the UK Self-Centering Guide Catheter Feasibility Study Dedicated Sheath Feasibility Study Feasibility And Safety of Early Discharge After Transfemoral Transcatheter Aortic Valve Implantation Left Atrial Appendage CLOSURE for the Prevention of Thromboembolisms in Patients Undergoing Aortic Bioprosthesis Surgery Low-dose-contrast Cardiac Computed Tomography CoreValve Evolut Pro Registry 18-F Sodium Fluoride (18F-NaF) PET for the Assessment of Bioprosthetic Aortic Valve Durability and Outcomes Conscious Sedation vs General Anesthesia in TAVR Patients Association of Type of Anesthetic and Outcomes in Transfemoral Aortic Valve Replacement Temporary Pacemaker in Transcatheter Aortic Valve Implantation Patients Inflammatory Response in Aortic Valve Replacement CoreValve Advance-II Study: Prospective International Post-market Study Impact of Home-based Cardiac Rehabilitation on Outcomes After TAVR Cardiac Magnetic Resonance Imaging Versus Computed Tomography to Guide Transcatheter Aortic Valve Replacement EDWARDS INTUITY Elite Valve System Clinical and Geriatric Assessment in Elderly Patients Before and After TAVI or MitraClip Positioning Safety and Effectiveness of Edwards Lifesciences SAPIEN 3 Transcatheter Heart Valve (THV) in the Chinese Population Safety and Effectiveness of Edwards Lifesciences SAPIEN XT THV in the Chinese Population Physical Activity in Patients After Aortic Valve Replacement (Valve-ex) Portico Re-sheathable Transcatheter Aortic Valve System US IDE Trial Rotterdam EDOXaban Leaflet Evaluation in Patients After Transcatheter Aortic Valve Implantation The preDIlatation in tRanscathEter aortiC Valve implanTation Trial Transfemoral Placement of Aortic Balloon Expandable Transcatheter Valves Trial (Europe) Non-invasive Blood Pressure and Cardiac Output Measurement by Using Applanation Tonometry Surgical Trauma After Partial Upper Hemisternotomy Versus Full Sternotomy Aortic Valve Replacement Platelet Reactivity After TAVI: A Multicenter Pilot Study Placement of Aortic Balloon Expandable Transcatheter Valves Trial (TransApical) Direct Left Ventricular Rapid Pacing Via the Valve Delivery Guide-wire in TAVI Assessments of Thrombus Formation in TAVI Aortic Valve and Root Measurements Under Real-Time 3-Dimensional Visualization During Angiography TAVI Protocol – Paravertebral Block Study Evaluate the Transcatheter Artificial Aortic Valve and Transcatheter Artificial Heart Values Delivery System ADVANCE Direct Aortic Study German Aortic Valve Registry Transmural Systems Transcaval Closure Device for Transcaval Access Ports During Transcatheter Aortic Valve Replacement Transfemoral Transcatheter Aortic Valve Implantation With or Without Predilation of the Aortic Valve (EASE-IT TF) Sizing of the PERCEVAL® Sutureless Aortic Valve Prosthesis Using the CT: a Feasibility Study A STEP for Patients Prior to Undergoing TAVR: A Pilot Study Balloon Expandable Transcatheter Aortic Valve Implantation Without Predilation of the Aortic Valve Left Ventricular Reverse Remodeling In Aortic Valve Replacement With Single Strip Pericardium Versus Mechanical Valve Engager Align Post-market Clinical Study Improved HRV, Inflammation Markers and Endothelial Function After TAVI Diagnostic Three Dimensional Echocardiography Study Protocol DEFLECT III: A Prospective, Randomized Evaluation of the TriGuard™ HDH Embolic Deflection Device During TAVI Subclinical Aortic Valve Bioprosthesis Thrombosis Assessed With 4D CT The Asian Pacific TAVR Multicenter Registry Safety and Performance of TAVI of Venus MedTech Aortic Valve Prosthesis Multi Modal Cardiac Imaging Prior Transcatheter Aortic Valve Implantation Surgical Treatment of Aortic Stenosis With a Next Generation, Rapid Deployment Surgical Aortic Valve Added Value of Patient-specific Computer Simulation in Transcatheter Aortic Valve Implantation (TAVI) Transcatheter Aortic Valve Replacement System Pivotal Trial Cerebrovascular EveNts in Patients Undergoing TranscathetER Aortic Valve Implantation With Balloon-expandable Valves Versus Self-expandable Valves. 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POLESTAR Trial – An International Multi-center Early Discharge TAVI Program REPRISE EDGE 29 mm EU Study The CONFIDENCE Registry Interest of Cardiac Computed Tomography to Optimize and Improve the Procedure of TAVI Transapical Implantation of the Medtronic Engager Transcatheter Aortic Valve Implantation System – The Engager European Pivotal Trial Post-Market Follow-up of the CENTERA Transcatheter Heart Valve System SecOnd-generation seLf-expandable Versus Balloon-expandable Valves and gEneral Versus Local Anesthesia in TAVI Balloon Aortic Valvuloplasty During Surgical Aortic Valve Replacement The PROTEMBO SF Trial Adjuvant Radiation in Aortic Valvuloplasty – ARAVA Value of Oral Phytate (InsP6) in the Prevention of Progression of the Cardiovascular Calcifications Supra-Annular vs. Annular ValvEs for Small Annuli Heart Leaflet Technologies Valve Study A Study to Evaluate the Neuro-embolic Consequences of TAVR Femoral vs Radial Approach and MRI Evaluation of Strokes Mortality Post-TAVI and Correlation With Haemodynamic Parameters. Pilot Study of Cognitive and Functional Outcomes Following TAVI Neuropsychological Testing in Patients Undergoing Transvascular Aortic Valve Implantation Costs, Cognitive Abilities and Quality of Life After Transcatheter Aortic Valve Implantation and Surgical Aortic Valve Replacement SOURCE XT REGISTRY Imaging Histone Deacetylase in the Heart A pragmatiC sTrategy to Promote actIVity and Enhance Quality of Life AFTER Transcatheter Aortic Valve Replacement The PARTNER II Trial: S3iCAP Symetis ACURATE Neo™ Valve Implantation SAVI TF Registry X-ray Fluoroscopy Fused With Computed Tomography (XFC) Technical Development First in Man Study of the JenaValve TAVI Plus System Transfemoral Evaluation of Fractional Flow Reserve Calculated by Computed Tomography Coronary Angiography in Patients Undergoing TAVR Ascending Aortic Dilation in BiAV After TAVR Safety and Performance Study of the Optimum Transcatheter Aortic Valve Transcatheter Aortic Valve Replacement With Extracorporeal Life System Support The TransCatheter Valve and Vessels Trial TAVR Without Predilatation Safety and Efficacy Study of MicroPort’s Transcatheter Aortic Valve and Delivery System for TAVI Enable® Aortic Sutureless Bioprosthesis Evaluation Radiation Following Percutaneous Balloon Aortic Valvuloplasty to Prevent Restenosis Myocardial Flow Reserve in Severe AS Without Obstructive Coronary Artery Disease Clinical Significance of Collagen Metabolism Changes in Left Cardiac Ventricle Medtronic CoreValve Evolut R U.S. Clinical Study (Evolut 34R Addendum) HLT transfemOral Replacement of aortIc Valve Via transcatherteriZatiON CANADA Aortic Stenosis Pre-Transcatheter Aortic Valve Replacement (TAVR) Procedure CT Scan PREVAIL-20J – Transfemoral Placement of 20mm Aortic Balloon Expandable Transcatheter Valve Trial RESPOND EDGE Post Market Study Impact of SAVR and TAVR on Patient’s Activity and Mobility BIOVALVE – I / II Clincial Investigation Comparison of Blood and Crystalloid Cardioplegia Ventriculo-arterial Coupling Modification Evaluated by PRAM During TAVI Procedure CoreValve Advance International Post Market Study HLT transfemOral Replacement of aortIc Valve Via transcatherteriZatiON SWISS TAVI Registry CoreValve™ Evolut R™ FORWARD Study Transfemoral Replacement of Aortic Valve With HLT MeriDIAN Valve Early Feasibility Trial Follow-up After TAVR Without Systematic Intensive Care Unit Admission ACURATE NEO/TF Transcatheter Heart Valves and Non-inferiority Versus Medtronic CoreValve Systems CoreValve™ Evolut R™ 34 mm System Registry (CoreValve34) Inflammation and Thrombosis in Patients With Severe Aortic Stenosis After Transcatheter Aortic Valve Replacement (TAVR) ACURATE TA™ Valve Implantation Registry: SAVI 2 Colibri Transcatheter Aortic Heart Valve System Study HLT Meridian Valve CE Mark Trial Transfemoral Replacement of Aortic Valve With HLT MeriDIAN Valve Feasibility Trial CANADA Assessment of Arrhythmias in Patients Undergoing Transcatheter Aortic Valve Implantation Using a Small Insertable Cardiac Monitoring Device Reactive Oxygen Species Following Aortic Valve Replacement Biological Factors Associated With Subclinical Valvular Thrombosis Hemodynamic Comparison of Tissue Aortic Valves Volume Challenge Added to DSE in the Diagnosis of Severe LFLGAS Impact of Perioperative Treatment With Intravenous Glutamine on Myocardial Protection in Cardiac Surgery Patients With Aortic Stenosis The Effects of High Spinal Anesthesia on Heart Function, Stress Response and Pain Control in Aortic Valve Surgery A Clinical Trial of Transcatheter Aortic Valves in Dialysis Patients (Japan) Erythropoietin + Iron Therapy for Anemic Patients Undergoing Aortic Valve Replacement A Study Evaluating the Effects of Ataciguat (HMR1766) on Aortic Valve Calcification Efficacy of Angiotensin Receptor Blocker Following aortIc Valve Intervention for Aortic STenOsis: a Randomized mulTi-cEntric Double-blind Phase II Study Prehabilitation to Improve Functional and Clinical Outcomes in Patients With Aortic Stenosis Evaluation of Transcatheter Aortic Valve Replacement Compared to SurveilLance for Patients With AsYmptomatic Severe Aortic Stenosis Phono- and Electrocardiogram Assisted Detection of Valvular Disease The Medtronic TAVR 2.0 US Clinical Study PREVAIL-J – Transfemoral & Transapical Placement of Aortic Balloon Expandable Transcatheter Valves Trial (Japan) Regression of Myocardial Fibrosis After Aortic Valve Replacement Transcatheter Aortic Valve Replacement Versu Surgical Aortix Valve Replacement for Treating Elderly Patients With Severe Aortic Stenosis and Small Aortic Annuli: A Prospective Randomized Study The VIVA Trial ACURATE Neo™ AS Aortic Bioprosthesis for Implantation Using the ACURATE neoTM AS TF Transfemoral Delivery System in Patients With Severe Aortic Stenosis THE ALIGN-AS TRIAL: JenaValve Pericardial TAVR Aortic Stenosis Study Prognostic Impact of Myocardial Longitudinal Strain in Asymptomatic Aortic Stenosis: a Meta-Analysis Severe Aortic Valve Stenosis and Concomitant Coronary Artery Disease in Patients Undergoing TAVI Treatment of Aortic Stenosis in Brazil: Cost-Utility Analysis of TAVI vs SAVR Clinical Evaluation of MDT-2111 in Subjects With Small Aortic Annuli and Symptomatic Severe Aortic Stenosis Valvuloplasty Scoring Balloon Catheter First-in-Man Study Effect of Angiotensin II Receptor Blockers (ARB) on Left Ventricular Reverse Remodelling After Aortic Valve Replacement in Severe Valvular Aortic Stenosis Surgical Treatment of Aortic Stenosis With a Next Generation Surgical Aortic Valve Registry to Evaluate the Impact of a Valve Coordinator on Aortic Stenosis / TAVI Outcome – (German Pilot) Quality of Care in AS IMPULSE Study Biomarkers in Aortic Stenosis – B.A.S.S. CoreValve® System Australia/New Zealand Clinical Study The Role of Cardiac Mechanics, Biomarkers and Frailty in Aortic Stenosis High-Sensitivity Troponin T Plasma Levels in Patients With Aortic Stenosis (Tyrolean Aortic Stenosis Study-2) Role of Active Valvular Calcification and Inflammation in Patients With Aortic Stenosis Interest of Pulse Wave Velocity Measurement as a Predictor of Severity of Aortic Stenosis A Prospective Study of Fractional Flow Reserve Assessment of Intermediate Coronary Stenoses in Severe Aortic Stenosis Prospective Balloon Aortic Valvuloplasty Identification of Parameters in rapId-proGression Subgroup Patients With Moderate Aortic Stenosis RHEIA (Randomized researcH in womEn All Comers With Aortic Stenosis) Effects of High Dose Atorvastatin in Patients With Surgical Aortic Stenosis Early Surgery for Patients With Asymptomatic Aortic Stenosis Predicting Aortic Stenosis Progression by Measuring Serum Calcification Propensity Bicuspid Aortic Valve Stenosis and the Effect of vItamin K2 on Calciummetabolism on 18F-NaF PET/MRI Endothelial Progenitors in Aortic Stenosis: Association With Aortic Stenosis Progression and Severity Outcomes of Transcatheter Aortic Valve Implantation in Oncology Patients With Severe Aortic Stenosis Evaluation of BAV in Different Hemodynamic Entities of Severe AS Intravenous Iron Supplement for Iron Deficiency in Patients With Severe Aortic Stenosis The SAPIEN 3 Ultra System in Intermediate Risk Patients With Symptomatic Severe Aortic Stenosis Clinical Value of Stress Echocardiography in Moderate Aortic Stenosis CENTERA THV System in Intermediate Risk Patients Who Have Symptomatic, Severe, Calcific, Aortic Stenosis Requiring Aortic Valve Replacement Outcomes of Transcatheter Aortic Valve Implantation in Management of Severe Symptomatic Aortic Stenosis Safety and Efficacy of Lotus Valve For TAVI In Patients With Severe Aortic Stenosis In Chinese Population Rehabilitation in Aortic Stenosis Patients Aortic Stenosis Evaluated Via Modern Ballistocardiography and Seismocardiography Study of Platelet Activation by Severe Aortic Stenosis and Its Correction by Transcatheter Aortic Valve Implantation Sizing-sTrategy of Bicuspid AoRtic Valve Stenosis With Transcatheter Self-expandable Valve The Plasma Serotonin and Aortic Stenosis: a Pilot Study. 18F-NaF Uptake and Aortic Stenosis Progression Cardiovascular Rehabilitation in Patients With Severe Aortic Stenosis Submitted to Valvar Correction Aortic Stenosis and PhosphodiEsterase Type 5 iNhibition (ASPEN): A Pilot Study Clinical Outcome of Patients With Low-gradient Severe Aortic Stenosis Ultrasonic Markers for Myocardial Fibrosis and Prognosis in Aortic Stenosis Fetal Intervention for Aortic Stenosis and Evolving Hypoplastic Left Heart Syndrome The PARTNER 3 – Trial – The Safety and Effectiveness of the SAPIEN 3 Transcatheter Heart Valve in Low Risk Patients With Aortic Stenosis Ventricular Remodeling In Patients With Aortic Stenosis Assessed Echocardiography Podocan and Wnt Pathway in Left Ventricular Remodeling of Aortic Stenosis Preoperative Assessment of Aortic Valve Stenosis and Coronary Artery Disease Statin Therapy in Asymptomatic Aortic Stenosis Validation of the “TASQ” in Patients Undergoing SAVR or TF-TAVI Analysis and Comparative Evaluation of Aortic Calcium by Computed Tomography and Histopathology in Patients With Aortic Stenosis Improving Echo Measurements in the Diagnosis of Aortic Stenosis accuRate Evaluation of Benefit With Optimal Medical Treatment With or With-Out Transcatheter Valve Repair of PARADOXical Low Flow Low Gradient Aortic Stenosis – REBOOT-PARADOX Aortic Stenosis: Determinants and Prognostic Value of Preoperative Left Ventricular Remodeling After Valvular Replacement Randomized Study for the Optimal Treatment of Symptomatic Patients With Low Gradient Severe Aortic Valve Stenosis and Preserved Left Ventricular Ejection Fraction Microvascular Dysfunction in Aortic Stenosis Percutaneous Aortic Valve 18F System for the Treatment of Patients With Severe Aortic Stenosis Determination of the Acute Effects of Aortic Stenosis on Coronary Artery Haemodynamics Mechanism of Decompensation Evaluation – Aortic Stenosis Speckle Tracking Imaging in Patients With Low Ejection Fraction Aortic Stenosis (SPArKLE-AS) A Comparison of Advanced Imaging Techniques in Aortic Stenosis Aortic Valve Replacement Versus Conservative Treatment in Asymptomatic Severe Aortic Stenosis Microparticles in Severe Aortic Stenosis Aortic Stenosis and PhosphodiEsterase iNhibition With Aortic Valve Replacement (ASPEN-AVR): A Pilot Study An Investigational Drug on Clinical Outcomes in Patients With Aortic Stenosis (Narrowing of the Major Blood Vessel of the Heart)(MK-0653A-043 AM4)(COMPLETED) Clinical Evaluation of MDT-2111 in Subjects With Symptomatic Severe Aortic Stenosis Acute Hemodynamic Effects of Sildenafil in Patients With Severe Aortic Stenosis Transapical Transcatheter Treatment Versus Conventional Surgery in Patients With Native Aortic Valve Stenosis Measurement of Myocardial Stiffness Using Elastometry in Patients With Aortic Stenosis Study to Improve Outcomes in Aortic Stenosis Multicenter Prospective Study of Low-Flow Low-Gradient Aortic Stenosis (TOPAS Study) Severe Aortic Stenosis in Patients Referred for Valve Surgery Frailty and Mortality in Older Old With Severe Aortic Stenosis Myocardial Efficiency of the Left Ventricle in Asymptomatic Patients With Aortic Valve Stenosis – a Prognostic Marker and a Target for Intervention? PCSK9 Inhibitors in the Progression of Aortic Stenosis Early Surgery Versus Conventional Treatment in Very Severe Aortic Stenosis Randomized Study to Evaluate the Efficacy of Fluvastatin on Inflammatory Markers in Patients With Aortic Stenosis. 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Brief Title

Influence of EPICardial Adipose Tissue in HEART Diseases: EPICHEART Study

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

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.

Study Type

Observational

Primary Outcome

New onset atrial fibrillation

Secondary Outcome

 Left ventricular hypertrophy by transthoracic echocardiography and magnetic resonance imaging

Condition

Coronary Artery Disease

Intervention

Aortic valve replacement

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status

Other

Estimated Enrollment

500

Start Date

September 1, 2014

Completion Date

November 25, 2018

Primary Completion Date

November 25, 2015

Eligibility 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).

Gender

All

Ages

18 Years - N/A

Accepts Healthy Volunteers

No

Contacts

, 00351961529516, [email protected]

Location Countries

Portugal

Location Countries

Portugal

Administrative Informations

NCT ID

NCT03280433

Organization ID

SFRH/BD/104369/2014

Responsible Party

Principal Investigator

Study Sponsor

Centro Hospitalar de Vila Nova de Gaia/Espinho, E.P.E.

Collaborators

 Universidade do Porto

Study Sponsor

, ,

Verification Date

September 2017