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Found 2 Actively Recruiting clinical trials
Actively Recruiting
Researchers are evaluating the effects of a triple therapy inhaler combining budesonide, glycopyrronium, and formoterol fumarate BGF MDI 32014.49.6 g compared to a dual therapy inhaler with glycopyrronium and formoterol fumarate GFF MDI 14.49.6 g on heart and lung outcomes in adults with Chronic Obstructive Pulmonary Disease COPD who have a higher risk for heart and lung events. This Phase III study is randomized, double-blind, and conducted at multiple centers, focusing on participants with COPD and elevated cardiopulmonary risk. Participants will receive either the triple therapy inhaler or the dual therapy inhaler, both administered twice daily. The study compares these two inhalers over a period of up to three years, monitoring for serious cardiac or COPD events. The trial includes careful evaluation of various heart and lung-related health events during this period. During the study, participants will be closely monitored through regular visits, assessments, and tests to measure lung function, heart events, and COPD exacerbations. Researchers will track the time until the first severe cardiac or COPD event and evaluate other cardiovascular and respiratory outcomes over up to three years. Participants will also be assessed for their ability to properly use the inhaler and adherence to the study protocol throughout the trial.
Actively Recruiting
Researchers are evaluating the safety, effectiveness, and clinical outcomes of percutaneous coronary intervention PCI for chronic total occlusions CTO in patients treated in routine clinical practice in Poland. The study seeks to understand procedural success rates, complications, and how different PCI strategies, intravascular imaging, mechanical support, and artificial intelligence analysis impact patient outcomes and quality of life. It also focuses on outcomes in various patient subgroups, including those with complex medical histories. This observational study enrolls patients undergoing CTO PCI as part of their standard care in a national, multicenter registry. Clinical, procedural, and follow-up data are collected prospectively to assess real-world outcomes. The study compares PCI performed with and without intravascular imaging and evaluates different treatment strategies such as drug-coated balloons, drug-eluting stents, and hybrid approaches. It also monitors the use of mechanical circulatory support and applies AI-based analysis of baseline electrocardiograms for outcome prediction. Participants will be followed to measure technical success of the procedure and monitor procedural details such as procedure time, fluoroscopy time, radiation dose, contrast volume, and procedural complications within one day. Additional outcomes include target lesion failure during hospital stay and up to one year, as well as mortality at one year. The study collects information on post-procedure cardiac injury markers and quality-of-life improvements, with data gathered throughout routine clinical care over the follow-up period.