Cinisello Balsamo

Researchers are evaluating the effects of intensified lipid-lowering therapy including Evinacumab on coronary atherosclerotic plaque burden in patients with Homozygous Familial Hypercholesterolemia (HoFH), a rare genetic disorder causing very high LDL cholesterol and increased risk of early heart disease. This observational, multicenter study compares patients receiving Evinacumab alongside standard treatments to those on conventional lipid-lowering therapy without Evinacumab, aiming to understand its impact on coronary plaque progression using coronary computed tomography angiography (CCTA). The study collects both retrospective data from up to 30 months before enrollment and prospective data for up to 24 months, involving about 52 patients across European centers. Patients are grouped based on routine clinical care decisions: those who started Evinacumab as add-on therapy within 24 months before enrollment and those continuing standard lipid-lowering therapy without Evinacumab. No treatments or procedures are mandated by the study. CCTA scans performed as part of clinical care are analyzed centrally with AI-based software to measure coronary plaque volume and characteristics. Participants provide data from routine clinical visits, including baseline and follow-up CCTA scans at 18-24 months after starting therapy. Researchers assess changes in non-calcified plaque volume as the primary outcome, along with total plaque burden, high-risk plaque features, and LDL cholesterol levels. Patient-reported outcomes and other imaging markers like pericoronary adipose tissue and supravalvular atherosclerosis are also evaluated. Safety information is gathered from clinical records, with no additional procedures required. The study aims to generate real-world evidence to help optimize cardiovascular risk management in HoFH patients.

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 comparing two different regional anesthesia techniques for pain relief after elective total hip replacement surgery performed through the anterior approach. This randomized controlled trial aims to evaluate which combination of nerve blocks better controls postoperative pain. The study focuses on adults undergoing this type of surgery with spinal anesthesia and measures pain and recovery outcomes after the procedure. Participants will be randomly assigned to one of two treatment groups. One group receives a Pericapsular Nerve Group (PENG) block combined with a Lateral Femoral Cutaneous Nerve (LFCN) block, where local anesthetic is injected near specific nerves using ultrasound guidance. The other group receives a PENG block combined with wound infiltration (WI), where anesthetic is applied along the surgical incision. Both approaches involve established clinical procedures with minimal added risk. During the study, pain intensity at rest will be measured 6 hours after surgery as the primary outcome using a numerical rating scale. Additional assessments include dynamic pain scores at multiple time points, opioid use, time to first additional pain medication, muscle strength, hip movement, length of hospital stay, and any adverse events. Safety will be carefully monitored by the research team throughout the trial.

Researchers are evaluating the effect of abelacimab compared to a placebo in patients with atrial fibrillation (AF) who are considered unsuitable for oral anticoagulation therapy. This study focuses on people at high risk for ischemic stroke or systemic embolism and aims to assess the safety and effectiveness of abelacimab in preventing these events. The study is a Phase 3, multicenter, randomized, double-blind, placebo-controlled trial involving patients with AF who have specific risk factors and treatment challenges. Participants will receive either abelacimab, provided as a liquid in vials at 150 mg/mL, or a matching placebo liquid. The study design includes parallel groups with blinded treatment assignment. The trial does not describe additional treatment phases or extensions but focuses on the comparison of abelacimab and placebo over the study duration. During the study, participants will be monitored for up to 30 months to measure the time until the first occurrence of ischemic stroke or systemic embolism, as well as the time until the first occurrence of serious bleeding as defined by the Bleeding Academic Research Consortium (BARC) type 3c/5 bleeding. Safety and efficacy will be closely evaluated, with ongoing assessments to track these outcomes throughout the follow-up period.