Altamura

Researchers are evaluating AZD0780, an oral PCSK9 inhibitor, in a phase 3, randomized, placebo-controlled study. This trial focuses on patients with established atherosclerotic cardiovascular disease ASCVD or those at high risk for a first ASCVD event. The study aims to assess how AZD0780 compares to placebo in reducing the risk of major adverse cardiovascular events, also known as MACE-PLUS, over the course of the trial. Participants are randomly assigned to receive either oral AZD0780 once daily or a matching placebo once daily. The study continues until a primary analysis censoring date, which may be up to approximately 54 months from randomization. After this, a study closure visit will be conducted as the final visit for each participant. During the study, participants will be regularly monitored for cardiovascular events including heart attacks, strokes, urgent coronary revascularizations, and other related outcomes. Researchers will track the time to first occurrence of these events as the primary outcome. Safety and other secondary outcomes like all-cause mortality will also be assessed. The total participation time can last up to about 54 months, with ongoing evaluations throughout this period.

Researchers are evaluating the EuroHeart program, an observational and prospective multicenter initiative designed to improve quality of care for patients with common cardiovascular diseases such as Acute Coronary Syndrome ACS, heart failure, and atrial fibrillation. EuroHeart collects standardized and harmonized patient data to support continuous quality improvement by monitoring adherence to quality indicators defined by the European Society of Cardiology ESC. The program aims to understand how well proven treatments are applied in everyday clinical practice. The study involves continuous data collection from consecutive patients hospitalized or treated for these cardiovascular conditions. Participants enter a 12-month follow-up period during which clinical events and health status data are gathered. This registry specifically evaluates adherence to ESC quality indicators in Italian clinical practice, including measures such as time to reperfusion and prescription of recommended medications at discharge. Participants will be monitored through regular collection of clinical data over the 12 months following enrollment. Researchers will assess adherence to multiple ESC quality indicators related to treatment and management of STEMI and NSTEMI patients, including evaluations of left ventricular function, lipid levels, and use of dual antiplatelet therapy and other medications. The study also tracks cardiovascular and non-cardiovascular events during follow-up to support quality improvement efforts. Participation involves consent and data collection without experimental treatments.

Reference intervals are important tools used to interpret laboratory test results. This research aims to evaluate indirect methods for determining these reference intervals using routine clinical laboratory data instead of relying on samples from actively recruited healthy individuals. The study focuses on improving accuracy and efficiency in defining reference intervals, particularly for complete blood count CBC parameters, and highlights the need for age-specific reference intervals due to variations in hemoglobin levels among the elderly. The study is observational and analyzes large-scale retrospective data collected from routine clinical laboratory tests across multiple Italian regions. It evaluates the RefineR statistical method, an open-source tool designed to distinguish normal from pathological data efficiently. The study will assess regional differences, establish age- and sex-specific reference intervals, and evaluate variations caused by different laboratory instruments over a period of up to three years. Participants are not actively recruited since the study uses existing laboratory data. Researchers will analyze these data to define reference intervals and compare results across regions, age groups, and testing platforms. The primary outcome is the definition of indirect reference intervals for CBC parameters. Secondary outcomes include assessments of regional and instrument variations. The study will run from October 2025 to June 2028, with no direct participant involvement beyond data analysis.