JENAVALVE AS EFS TRIAL: Pericardial TAVR Aortic Stenosis Study
Aortic Valve StenosisHeart Valve Diseases3 moreTo collect information about treatment for severe aortic stenosis (AS), which affects the aortic valve in the heart. Aortic stenosis is a narrowing of the aortic valve opening, which decreases blood flow from the heart and causes symptoms such as chest pain, fainting and shortness of breath. The preferred treatment for severe aortic stenosis is aortic valve replacement surgery.
Effectiveness of Different Fibrinogen Preparations in Restoring Clot Firmness
HypofibrinogenemiaSurgical Blood Loss3 moreFibrinogen concentrate is produced by different manufacturers using different purification technologies. The products available in Italy are three: RIASTAP (CSL Behring), FIBRYGA (Octapharma), and FIBRICLOTTE (LFB). RIASTAP and FIBRYGA are sold in 1-gram vials, and FIBRICLOTTE - in 1.5 grams vials. A recent in vitro study assessed how these products affected the clot firmness measured by the ROTEM FIBTEM maximum clot firmness (MCF) parameter. In vitro conditions, FIBRICLOTTE was verified to be the most efficient in increasing clot firmness. The present study is aimed to assess, in a series of patients undergoing cardiac surgery with cardiopulmonary bypass, the hypothesis that the FIBRICLOTTE fibrinogen is superior to the RIASTAP fibrinogen in increasing the FIBTEM MCF parameter in a clinical model of bleeding (postoperative bleeding after complex cardiac surgery).
Electrocardiogram-based Artificial Intelligence-assisted Detection of Heart Disease
Atrial FibrillationStructural Heart DiseaseAtrial fibrillation is an abnormal beating of the heart that can lead to stroke or heart failure. Structural heart diseases are conditions that affect the heart valves or heart muscle and can cause permanent heart damage if left untreated. Sometimes people have atrial fibrillation or structural heart disease and do not know it. The purpose of this study is to evaluate two devices that can predict who has or may develop atrial fibrillation or structural heart disease based on the results of an electrocardiogram.
Randomization of Single vs Multiple Arterial Grafts
Coronary Artery DiseaseHeart DiseasesThe primary hypothesis of ROMA is that in patients undergoing primary isolated non-emergent coronary artery bypass surgery (CABG), the use of two or more arterial grafts compared to a single arterial graft is associated with a reduction in the composite outcome of death from any cause, any stroke, post discharge myocardial infarction and/or repeat revascularization. The secondary hypothesis is that in patients undergoing primary isolated non-emergent CABG, the use of two or more arterial grafts compared to a single arterial graft is associated with improved survival. Prospective event-driven unblinded randomized multicenter trial of at least 4,300 subjects enrolled in at least 25 international centers. Patients will be randomized to a single arterial graft (SAG) or multiple arterial grafts (MAG). Patients will be randomized in a 1:1 fashion between the two groups. Permuted block randomization with random blocks stratified by the center and the type of second arterial graft will be used to provide treatment distribution in equal proportion.
NO During CPB in Neonates to Reduce Risk of AKI
AKICHD - Congenital Heart Disease1 moreAcute kidney injury (AKI) following cardiac surgery for congenital heart defects (CHD) in children affects up to 60% of high risk-patients and is a major cause of both short- and long-term morbidity and mortality. Despite effort, to date, no successful therapeutic agent has gained widespread success in preventing this postoperative decline in renal function. Nitric oxide is an intricate regulator of acute inflammation and coagulation and is a potent vasodilator. The investigators hypothesize that nitric oxide, administered during cardiopulmonary bypass (CPB), may reduce the incidence of AKI.
Project 3: ACHIEVE- CHD
Coronary Heart DiseaseThis project is part of the ACHIEVE GREATER (Addressing Cardiometabolic Health Inequities by Early PreVEntion in the GREAT LakEs Region) Center (IRB 100221MP2A), the purpose of which is to reduce cardiometabolic health disparities and downstream Black-White lifespan inequality in two cities: Detroit, Michigan, and Cleveland, Ohio. The ACHIEVE GREATER Center will involve three separate but related projects that aim to mitigate health disparities in risk factor control for three chronic conditions, hypertension (HTN, Project 1), heart failure (HF, Project 2) and coronary heart disease (CHD, Project 3), which drive downstream lifespan inequality. All three projects will involve the use of Community Health Workers (CHWs) to deliver an evidence-based practice intervention program called PAL2. All three projects will also utilize the PAL2 Implementation Intervention (PAL2-II), which is a set of structured training and evaluation strategies designed to optimize CHW competence and adherence (i.e., fidelity) to the PAL2 intervention program. The present study is Project 3 of the ACHIEVE GREATER Center.
Non-invasive Point-of-care Diagnosis Using Machine Learning and Signal Analytics to Transform Early...
Coronary Artery DiseaseThis study is designed as a repository study to collect resting cardiac phase signals and subject meta data from eligible subjects using the Phase Signal Recorder (PSR) prior to coronary angiography. The repository data will be used for the purposes of research, development, optimization and testing of machine-learning algorithms developed by Analytics 4 Life.
Study of Cardiac Lesions Angiogenesis by 68Ga-NODAGA-RGD Cardiac PET
Myocardial InfarctionAcute2 moreThe study is about exploring physiological angiogenesis linked to tissue repair in patients with acute heart infarction or chronic heart ischemia by means of 68Ga-NODAGA-RGD PET/CT imaging.
Thymosin α1 Use in Rheumatic Heart Disease Patients Undergoing Cardiac Surgery on Cardiopulmonary...
Rheumatic Heart DiseaseCardiopulmonary Bypass1 moreRheumatic heart disease usually accompanied by weakened immune function. And the cardiopulmonary bypass further aggravating the decline of immune function. Therefore, the prevention of Postoperative immune function collapse is of great clinical value, and immunomodulatory therapy with thymosin alpha 1 may be beneficial. This study was designed to test the hypothesis that the administration of thymosin alpha 1 will Improve the immune function and prognosis of patients.
Impact of Surgical Timing on the Neurodevelopmental Prognosis of Newborns With Complex Congenital...
Complex Congenital Heart DiseaseWe propose a prospective observational study whose main objective will be to determine whether there is an association between age at surgery (days of life) and neurodevelopmental outcome in patients with CCHD. Secondly, we will study the relationship between age at surgery and (i) the incidence of WMI observed on pre- and post-operative cerebral MRI (ii) post-operative morbidity as defined by the occurrence of post-operative complications (haemodynamic, infectious, neurological, surgical) and (iii) the length of hospital stay.