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Found 2 Actively Recruiting clinical trials
Actively Recruiting
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.
Actively Recruiting
Researchers are evaluating the long-term clinical and instrumental response to Cardiac Contractility Modulation (CCM) therapy in adults with symptomatic heart failure caused by systolic left ventricular dysfunction, despite receiving optimal medical treatment. This observational cohort study includes both retrospective and prospective aspects. It aims to determine the proportion of patients who experience improvement in their New York Heart Association (NYHA) class by at least one level after 12 months, reductions in hospitalizations and emergency visits, changes in quality of life using the Minnesota Living with Heart Failure Questionnaire, walking distance improvements, and differences in NT-proBNP levels. Participants either already have or will receive the CCM device called "OPTIMIZER Smart Mini," which is implanted with leads in the heart's right ventricle and optionally the right atrium. This programmable implantable pulse generator delivers electrical impulses to improve heart function. The device is intended for patients over 18 years with symptomatic heart failure and reduced left ventricular function who have not responded sufficiently to medical therapy. The study evaluates responses following implantation, guided by preimplantation low-dose Dobutamine stress echocardiography. During the study, participants' clinical status and heart function are monitored through echocardiographic tests, quality-of-life questionnaires, and walking tests over a 12-month follow-up. Researchers track hospitalizations, emergency visits, and biomarker levels as well. The primary outcome is the change in NYHA class from enrollment to study end. Safety and effectiveness data are collected as part of participants' routine medical care, with the goal of better understanding who benefits most from CCM therapy.