Altamura

Researchers are evaluating AZD0780, an oral PCSK9 inhibitor, in a phase 3, randomized, placebo-controlled study to see if it can reduce the risk of major adverse cardiovascular events (MACE-PLUS) in adults with established atherosclerotic cardiovascular disease (ASCVD) or those at high risk for a first ASCVD event. The study compares AZD0780 to a placebo and monitors participants from randomization until the primary analysis censoring date, followed by a final study closure visit. Participants will be randomly assigned to receive either oral AZD0780 or an oral placebo once daily. The treatment period lasts until the primary analysis censoring date, after which a study closure visit will occur. The study is event-driven and designed to assess the time to the first major cardiovascular event during treatment. During the study, participants will be closely monitored with various assessments to evaluate cardiovascular outcomes and safety over approximately 54 months. Researchers will track the time to first event of any component of MACE-PLUS and collect data to assess the effect of AZD0780 compared to placebo. The study includes regular visits and evaluations to ensure participant safety and adherence to treatment.

Researchers are conducting an observational, prospective, multicenter study in Italian cardiology centers to evaluate how well patients with Heart Failure with Reduced Ejection Fraction (HFrEF) follow guideline-recommended treatments. The study also aims to assess the safety of these treatments, monitor treatment patterns in patients with acute heart failure, and observe treatment approaches in all chronic heart failure patients regardless of their ejection fraction levels. The study involves two phases of educational interventions and data collection. Initially, healthcare providers will receive education on guideline recommendations and treatment patterns, followed by 3 months of patient data collection or up to 30 consecutive patients with chronic or acute heart failure. After 6 months, treatment modifications and outcomes will be evaluated. Then, a second educational session will highlight gaps between guidelines and practice, followed by another 3 months of data collection. Patients will be followed for 12 months total, with ongoing monitoring of treatment changes and outcomes. Participants will be assessed at enrollment and during the follow-up periods through clinical evaluations and data collection on treatment adherence and safety. The main outcome measured is adherence to guideline-directed medical therapies over 6 months. The study includes evaluations at 6 and 12 months after enrollment, with close monitoring of treatment patterns and patient health status throughout the study duration.

Researchers are evaluating patients who have experienced athero-thrombotic events such as coronary artery disease, cerebrovascular disease, or peripheral artery disease. The study aims to assess how well patients follow guideline recommendations, particularly focusing on improving cholesterol levels and other modifiable risk factors to reduce the chance of cardiovascular event recurrence. This observational and prospective study takes place across multiple cardiology centers in Italy to represent a broad patient population. The study includes several phases starting with an educational intervention to discuss guideline recommendations for secondary prevention. Following this, data is collected for three months or until 30 patients with documented cardiovascular conditions are enrolled, using a web-based case record form that identifies when guidelines are not followed and records reasons for non-adherence. After six months, primary and secondary outcomes are evaluated. A second educational intervention then shares findings from the first phase to highlight gaps in clinical practice, followed by another three-month data collection period and a further six-month outcome assessment. Finally, all patients are followed for 12 months to monitor longer-term results. Participants provide informed consent and are monitored through data collection forms that track adherence to guidelines and clinical outcomes. The main outcome measured is adherence to cholesterol management guidelines over six months. Additional assessments include adherence to recommendations for other cardiovascular risk factors. Throughout the study, researchers gather data to understand how guideline adherence affects patient health and to identify barriers to following best practices, with continuous follow-up over a year to evaluate sustained effects.

Researchers are evaluating a program called EuroHeart, developed by the European Society of Cardiology (ESC), which aims to improve care for patients with common heart conditions like Acute Coronary Syndrome (ACS), heart failure, and atrial fibrillation. This observational, prospective, multicenter initiative collects standardized patient data continuously in real-world clinical settings to support ongoing quality improvement. The focus is on how well healthcare providers follow ESC quality indicators proven to improve patient outcomes, addressing gaps between research and everyday practice. The study specifically looks at the Italian implementation of EuroHeart, monitoring adherence to ESC quality indicators in clinical care. It does not involve experimental treatments but collects detailed data on the management of patients hospitalized with ACS, heart failure, or atrial fibrillation. Participants' care is tracked throughout their hospital stay and beyond, with no additional interventions imposed by the study. Participants will be followed for 12 months after enrollment. During this period, researchers will collect data on clinical events, treatment adherence, and patient status to evaluate how well ESC quality indicators are met, such as timely reperfusion for STEMI patients and appropriate medication prescriptions at discharge. This long-term follow-up supports efforts to enhance care quality and patient outcomes in cardiovascular diseases.

Reference intervals are important for interpreting laboratory test results. Traditionally, these intervals are based on samples from healthy individuals, which requires recruiting volunteers and is costly and time-consuming. Advances in electronic health records and laboratory test data have made it possible to define these intervals indirectly, using routine clinical laboratory data instead of actively recruiting healthy subjects. Indirect methods analyze routine data to determine reference intervals more quickly and cheaply while avoiding the selection bias of very healthy populations. One advanced technique called RefineR offers accurate, robust, and efficient statistical modeling to separate normal from abnormal data. This method is available as an open-source tool and has been promoted by the International Federation of Clinical Chemistry and Laboratory Medicine for its benefits. The study aims to define indirect reference intervals for complete blood count parameters by analyzing large-scale retrospective laboratory data collected over up to 3 years. The research also considers age-related changes in hemoglobin levels, especially in older adults, to provide age-specific reference intervals that are currently lacking in many laboratory reports. This can improve diagnostic accuracy for patients of various ages.