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This research aims to evaluate the long-term safety and tolerability of pelacarsen (TQJ230) in adults with established cardiovascular disease and elevated Lipoprotein(a) who have completed the parent trial CTQJ230A12301. The study is an open-label extension following the phase 3 parent study, providing participants continued access to pelacarsen after the initial trial. Participants will receive pelacarsen 80 mg by subcutaneous injection once a month during this open-label extension. The study is single-arm and multicenter, focusing on continued treatment with pelacarsen for up to 36 months after completion of the parent study. Throughout the study, participants will be monitored regularly to assess safety and tolerability, with particular attention to adverse events occurring up to 36 months. Researchers will collect data on health status throughout this period to understand the long-term effects of pelacarsen in this patient population.

This research is a national, prospective, multicenter pilot project focused on establishing a combined first trimester screening in the Czech Republic. The screening aims to predict and detect serious pregnancy complications such as preeclampsia, fetal growth restriction, preterm labor, intrauterine fetal demise, and structural congenital defects, including chromosomal abnormalities like trisomies 21, 18, and 13. The project seeks to unify the screening methodology and link clinical data with the National Health Information System to improve pregnancy care quality and accessibility across all population groups. The combined first trimester screening includes collecting maternal, ultrasound, biochemical, and biophysical parameters. Certified software from the Fetal Medicine Foundation will be used to assess individual risks for preeclampsia, fetal growth restriction, and fetal chromosomal aneuploidies based on these inputs. The methodology will be tested on a sample of 2000 women in their 11th to 13th gestational weeks. This screening is not routinely covered by public health insurance, so the project aims to model reimbursement mechanisms. Participants will be involved during the first trimester of pregnancy when these parameters are collected and analyzed. Researchers will measure the proportion of women identified with an increased risk of preeclampsia, fetal growth restriction, or fetal chromosomal abnormalities from June 2025 to October 2026. The project supports better health outcomes by standardizing screening processes and improving care access, including for socially excluded groups.