View clinical trials related to Heart Diseases.
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Background: Multiple neonatal disorders are associated with risks of neurological injury. Thus, management of these infants should involve a coordinated approach to permit early diagnosis with improved clinical care. Such initiative involves the use of standardized protocols, continuous and specialized brain monitoring with electroencephalography (EEG), amplitude integrated EEG (aEEG) and Near Infrared Spectroscopy (NIRS), neuroimaging and training. Brazil is a very large country with disparities in health care assessment; some neonatal intensive care units (NICUs) are not well structured and trained to provide adequate neurocritical care. However, the development and implementation of these neurocritical care units requires high expertise and significant investment of time, manpower and equipment. In order to reduce the existing gap, a unique advanced telemedicine model of neurocritical care called Protecting Brains and Saving Futures (PBSF) protocol was developed and implemented in some Brazilian NICUs. Methods: A prospective observational cohort study will be conducted in 20 Brazilian NICUs that have adopted the PBSF protocol. All infants receiving the protocol during January 2021 to December 2023 will be eligible. Ethical approval will be obtained from the participating institutions. The primary objective is to describe the use of the PBSF protocol and clinical outcomes, by center and over a 3 years period. The use of the PBSF protocol will be measured by quantification of neuromonitoring, neuroimaging exams and sub-specialties consultation. Clinical outcomes of interest after the protocol implementation are length of hospital stay, detection of EEG seizures during hospitalization, use of anticonvulsants, inotropes, and fluid resuscitation, death before hospital discharge, and referral of patients to high-risk infant follow-up. These data will be also compared between infants with primarily neurologic and primarily clinical diagnosis. Discussion: The implementation of the PBSF protocol may provide adequate remote neurocritical care in high-risk infants with optimization of clinical management and improved outcomes. Data from this large, prospective, multicenter study are essential to determine whether neonatal neurocritical units can improve outcomes. Finally, it may offer the necessary framework for larger scale implementation and help in the development of studies of remote neuromonitoring.
The erector spinae plane block (ESPB) is a novel regional analgesic technique that provides pain relief with a peripheral nerve block catheter. The goal of this study is to see if bilateral ESPB catheters can improve clinical outcomes in patients undergoing cardiac surgery via sternotomy, such as decreasing the duration of postoperative mechanical ventilation, need for intravenous opioid medications, length of stay in the intensive care unit (ICU), and improving pain scores.
The aim of the study is to evaluate the influence of physical training and respiratory rehabilitation performed by patients at home on quality of life, symptoms, physical endurance, force of respiratory and skeletal muscles and body mass composition in patients with pulmonary arterial hypertension (PAH) or left ventricular heart failure with reduced ejection fraction - HFREF), or ischemic heart disease and evaluation the number of stem cells, natural lymphoid cells and distribution of subpopulations of monocytes (including proangiogenic monocytes) in examined persons and evaluation of theirs eventual influence of the course of disease.
Cardiovascular disease (CVD) occurs less frequently in women than in juvenile men.Frequently the estrogen deficiency associated with the menopausal state affects cardiovascular outcomes. In fact, in the post-menopausal state, even younger women may experience an increase in the rate of ischemic heart disease (IHD). On the other hand, CVD may also occur in premenopausal young women, due to not well known and/or not clearly investigated mechanisms. In addition, pre-menopausal women with IHD show atypical symptoms and more frequently myocardial infarction vs. angina pectoris. In detail, in these patients IHD is frequently due to mono-vessel coronary heart disease, and to the presence of cardiovascular risk factors such as hypertension, hyperlipidemia and type 2 diabetes. So, it is clear that all these pro-atherogenic risk factors which lead to IHD in women, are significantly lower in the pre-menopausal vs. post-menopausal patients. However, the causes leading to IHD and acute coronary events in pre-menopausal women remain poorly understood and poorly investigated, and these factors might be different from the traditional coronary risk factors evident in the general population. In this context, recently some authors have shown that subcutaneous abdominal fat affects cardiovascular performance at 1 year of follow-up in patients with normoglycemia vs. pre-diabetic. Therefore, here authors can hypothesize that in a population of female subjects, the fat tissue present in the mammary gland and the different degrees of mammary adipocyte infiltration can somehow invalidate the number of cardiovascular events in women of childbearing age. In detail, the different distribution of adipose tissue in the mammary gland can influence the density of the breast, as studied by mammographic examination, which is used to divide breast density into 4 different categories: - Category A: the breast is represented by 80% of adipose tissue and less than 20% by fibro-glandular tissue. - Category B: the breast is represented by adipose tissue in the range of 50-75% and for the rest by fibro-glandular tissue. - Category C: the breast is represented by fatty tissuein the range 25-50% and the rest is from fibro-glandular tissue - Category D: the breast is represented by almost entirely fibro-glandular tissue. Therefore, in the present study authors correlated the 4 different breast categories with CVD and 10-year follow-up IHD in women of child-bearing age. In fact, according to authors' opinion, a breast with higher fat density (category A) might influence the number of adverse cardiovascular events at 10-year follow-up in asymptomatic women. Thus, pre-menopausal women with breast tissue in category A ("fatty breast") as compared to women with prevalence of fibro-glandular tissue ("non-fatty breast") may have a higher frequency of adverse cardiac ischemic events at 10 years of follow-up. On the other hand, the molecular pathways implied in worse CVD in these cohorts of women are not fully investigated. Furthermore, the authors aimed to investigate the expression of inflammatory cytokines and sodium glucose transporter 2 (SGLT2) protein expression, as markers of over-inflammation, at level of breast gland in these cohorts of women. Thus, these markers were analyzed in the breast fat tissue excissed from the fatty vs. non-fatty breast women.
Each year world-wide, 2.5 million fetuses die unexpectedly in the last half of pregnancy, 25,000 in the United States, making fetal demise ten-times more common than Sudden Infant Death Syndrome. This study will apply a novel type of non-invasive monitoring, called fetal magnetocardiography (fMCG) used thus far to successfully evaluate fetal arrhythmias, in order to discover potential hidden electrophysiologic abnormalities that could lead to fetal demise in five high-risk pregnancy conditions associated with fetal demise.
The aim of this open-label (OL) trial is to study the long-term use of macitentan for up to 2 years in Fontan-palliated adult and adolescent patients beyond the 52 weeks of treatment in the parent RUBATO double-blind (DB) study (AC-055H301, NCT03153137). This OL trial studies the long-term effect of macitentan in Fontan-palliated patients as it is not known if the effect of macitentan is sustained beyond 52 weeks (end of the parent RUBATO DB study). In addition, the trial also studies the long-term safety of macitentan as this is also unknown. Furthermore, the opportunity will be given to patients who were on placebo in the parent RUBATO DB study to receive macitentan 10 mg and benefit from a potentially active treatment.
Shortness of breath is very common among patients on dialysis for kidney failure; however, its causes are often not understood. This study will explore the lungs and the heart of these patients to determine the causes of shortness of breath. The amount of salt in the body tissues, which tends to accumulate in dialysis patients and can also cause shortness of breath, will also be measured. Machines that exploit magnetic resonance, ultrasound and x-rays to take images of the body interior will be employed; in addition, breathing tests, questionnaires and blood tests will also be used. 20 patients on dialysis will be recruited and have two visits: one at the beginning of the study and one year later to observe any changes in the lungs, heart and salt accumulation over time.
The purpose of this study is to find the ideal range of the activated clotting time (ACT) during percutaneous coronary intervention (PCI) that is associated with lowering the rate of undesirable medical outcomes
In this study, simvastatin combined with Ezeimebum was used to enhance lipid reduction, and IVUS was used to evaluate the volume and composition of coronary plaque before and after treatment. The aim is to evaluate the overall intervention effect of Ezeimebum on stable angina pectoris with diabetes mellitus on the basis of statins.