Primary FIbrinolysis and Secondary STenting Versus immEdiate Stenting in ST-segment Elevation Myocardial...
Coronary Artery DiseaseMyocardial Ischemia8 moreThis prospective, multicenter, randomized, controlled, open-label clinical study has a target enrollment of 240 subjects. It will explore whether STEMI patients transferred to a PCI center following thrombolytic therapy and expected to have stent implantation might benefit from an alternative treatment strategy and the use of new technologies designed to improve myocardial protection throughout the medical care process.
Effect of Methylprednisolone on Systemic Inflammatory Response During Pediatric Congenital Open-Heart...
Cyanotic Heart DiseaseCardiopulmonary BypassThe goal of this study is to evaluate the effects of steroids on the early postoperative inflammatory response in patients undergoing elective pediatric congenital cardiac surgery, requiring cardiopulmonary bypass (CPB).
Using Indoor Air Filtration to Slow Atherothrombosis Progression in Adults With Ischemic Heart Disease...
Air PollutionAtherosclerosisThis double-blind, randomized, crossover trial aims to test the hypothesis that longer-term indoor air filtration intervention can slow atherothrombosis progression by reducing indoor fine particulate matter (PM2.5) exposure in adults with ischemic heart disease history.
Cerebrolysin in Prevention of Postoperative Delirium in Cardiac Surgery
Neurocognitive DisordersSurgery-Complications3 morePostoperative delirium (POD) and postoperative neuropsychological dysfunction are frequently noted in critically ill patients undergoing elective or emergency surgery and treated in the intensive care unit (ICU). Delirium is a serious complication that prolongs hospital stay and contributes to poor outcomes and increased risk of death. The pathomechanisms of delirium are still not very well recognized and there are several theories that seem to explain it. The most important pathomechanisms of delirium are associated with cerebral ischaemia, disorders in acetylcholinergic system, disorders in neuronal plasticity and oxidative stress. Cerebrolysin, a mixture of various peptides obtained from the structural proteins of the pig's brain, possesses strong antioxidative and neuronal protective properties. Cerebrolysin is recommended to treat patients with dementia, after cerebral ischemia and after brain trauma. It has been documented that Cerebrolysin reduces the severity of secondary brain damage after ischemia, improving neuronal plasticity and then cognitive function, and reducing severity of oxidative stress. Based on these properties it can be speculated that Cerebrolysin may reduce the risk of postoperative delirium in patients undergoing elective surgery, which are associated with a high risk of postoperative delirium.
Low Workload Concept for the Detection of Silent Atrial Fibrillation (AF) and Atrial Fibrillation...
Atrial FibrillationArrhythmias5 morePatient-centered novel e-health technology and services will lay the foundation for future healthcare systems and services to support health and welfare promotion. Yet, there is a lack of ways to incorporate novel technological innovations into easy-to-use, cost-effective and low workload treatment. The detection of atrial fibrillation (AF) paroxysms and its permanent form as well as the prevention of AF-related strokes are major challenges in cardiology today. AF is often silent or asymptomatic, but the risk of ischemic stroke seems to be similar regardless of the presence or absence of symptoms. CARE-DETECT algorithm development part I will investigate following topics: The usefulness and validity of bed sensor and mobile phone application in rhythm disorder capture compared to gold standard ECG-holter monitoring (Faros ECG) Accuracy of AF detection from PDL data Technical development of algorithms to detect arrhythmia from data collected with these novel devices Development of a pre-processing tool that will evaluate the collected data and generate a preliminary filtered report of the raw data to ease clinician's workload in data handling and rhythm evaluation. CARE-DETECT clinical trial (part II) proposal provides a new concept for low workload for healthcare personnel, high diagnostic yield in silent AF detection and AF burden evaluation. CARE-DETECT protocol proposal seeks to address following issues: Can a combination of actively used smartphone application and passive monitoring with bed sensor (with upstream ECG) - compared to routine care - enhance the detection of AF in patients who are at increased risk of stroke and have undergone a cardiac procedure? What is the actual AF burden in paroxysmal AF patients after the detection of new-onset AF? Can a direct-to-consumer telehealth with integrated cloud-based telecardiology service for medical professionals improve the efficacy of silent AF detection and what is the AF burden in patients suffering of (asymptomatic) paroxysmal AF and secondarily what is the cost-effectiveness of these new screening methods? Additionally, during the hospitalization phase of the study part II PDL data will be collected in the intervention group. PDL data will be analyzed offline with the purpose to develop new methods and will not be used to monitor treatment or for diagnosis.
Impact of Mobile Health in Improving Lifestyle and Therapeutic Adherence in Coronary Heart Disease...
Coronary DiseaseCardiovascular diseases are the leading cause of death worldwide. In high-income countries, approximately seventy percent of cardiovascular diseases cases are attributable to modifiable risk factors, with metabolic risk factors (obesity, cholesterol) and tobacco use being the most closely associated. Secondary prevention of coronary disease is considered essential, since it has contributed significantly to the reduction of morbidity and mortality, by facilitating the adoption and adherence to healthy behaviors, promoting an active lifestyle, and increasing adherence to pharmacological treatment. Information and communication technologies have been increasingly incorporated into health care systems, including the innovative provision of Cardiac Rehabilitation through a mobile phone or m-health interventions. M-health technology can provide evidence-based guidance in an interactive format that is attractive, easy to use, and reduces healthcare costs. The objective of this study is to evaluate, through a randomized controlled clinical trial, the effect of an intervention based on a web application of health, mobile Health, on lifestyle (diet, physical activity, and nicotine dependence) and therapeutic adherence in people with coronary heart disease. The sample will consist of 200 participants, 100 in the intervention group and 100 in the usual care group that will be evaluated at the beginning and 3, 6, and 12 months after hospital discharge regarding sociodemographic, clinical, cardiovascular risk factors, lifestyle, and therapeutic adherence characteristics. The educational intervention, monitoring, and self-monitoring will be carried out using a web-based m-Health tool, mobile phone application. The quantitative primary results will be compared between the two groups using analysis of covariance, adjusting for age and sex. Multivariate analysis will be carried out to examine the association of the intervention with life habits, control of cardiovascular risk factors as well as the evolution after discharge in respect of cardiovascular events, emergency and re-entry views.
Coronary Computed Tomography Angiography For Optimized Invasive Coronary examInation
Ischemic Heart DiseaseCoronary Artery DiseaseCoronary computed tomography angiography (CCTA) is a non-invasive method for visualization of the coronary arteries. The anatomical information obtained by CCTA, however, is rarely integrated into a subsequent coronary intervention. The CT-FOCI trial aims to evaluate, in a randomized setting, the benefit of implementing the information obtained by CCTA as part of the invasive examination using a CT-guided algorithm (CTGA). Patients (n=120) with symptoms of stable angina pectoris will be randomized 1:1 after CCTA has determined at least 1 stenosis with luminal diameter reduction of minimum 50% in a vessel segment > 2 mm in diameter. Subsequent, invasive examination and intervention will utilize the information available according to randomization. Primary efficacy endpoints are a reduction in patient radiation exposure, procedure time, procedural utensils, and contrast use. Secondary endpoints is significant stenosis in the non-target vessel, only available in the conventional group.
SATURN Transcatheter Mitral Valve Replacement for Functional Mitral Regurgitation
Mitral RegurgitationValve Heart Disease3 moreThis study is a prospective, single-arm, multi-center feasibility clinical study of the SATURN TA System for the treatment of NYHA Class ≥ II patients with severe functional mitral regurgitation who are not suitable for surgical treatment following Heart Team assessment.
Effect of Empagliflozin on Ventricular Repolarization.
Diabetes MellitusType 23 moreThe present project aims to investigate if the empagliflozin has an antiarrhythmic action. Analyzing the T-wave heterogeneity index, a new electrocardiographic risk marker associated with the prediction of cardiovascular risk, in diabetic patients and coronary artery disease, the investigators will verify if empagliflozin is associated with a reduction in electrical instability.
Respiratory Muscles and Work of Breathing in Children
Neuromuscular DiseasesCongenital Diaphragmatic Hernia5 moreRespiratory muscle testing allows a quantitative assessment of inspiratory and expiratory muscles in children of any age with primary or secondary respiratory muscle impairment, in order to better understand the pathophysiology of respiratory impairment and guide therapeutic management. The use of an invasive technique (esogastric probe) makes it possible to specifically explore the diaphragm, the accessory inspiratory muscles and the expiratory muscles in order to detect dysfunction or paralysis of these muscles, and to estimate the work of breathing in order to better guide the respiratory management. The primary objective of the study is to evaluate the respiratory effort in children with primary or secondary impairment of the respiratory muscles during spontaneous breathing or during mechanical ventilation.