FOCUS BioSeq

• Head of study: Professor Philipp S. Wild, MD
  

Summary

Acute pulmonary embolism (PE) is a frequent cause of death and serious disability with an incidence rate of 98/100,000 per year. It has been demonstrated that app. 25% of patients do not survive the first year after diagnosis, although the majority of deaths are not PE-related. The FOCUS study is a German, prospective, multicenter, observational cohort study. It is designed to determine the incidence and outcome of chronic thromboembolic pulmonary hypertension (CTEPH) and functional impairment after an index episode of acute pulmonary embolism (PE), over a 2-year follow-up period in approx. 1,000 patients. In total, 15 high-volume reference centers throughout Germany are enrolled. FOCUS BioSeq is a multi-center biobanking study with serial assessment of biomaterial from study participants from FOCUS in order to investigate the role of biomolecular and genetic biomarkers involved in sequelae of acute PE including CTEPH. After a decentralized collection of samples, specimens of EDTA-plasma, serum, Na-citrated-plasma, DNA, RNA, miRNA and urine will be hosted in a centralized biobank. Laboratory investigations on blood coagulation, immunity, inflammation, and cardiovascular disease are planned. More comprehensive analysis will be added including genome-wide association and sequencing analyses, as well as profiling of DNA methylation and miRNA.

Study Type	Observational
Study Design	prospective
Official Title	FOCUS BioSeq – Biochemical and Genetic Biomarkers in Sequelae of Acute Pulmonary Embolism (FOCUS BioSeq) Study
Financing	The study is conducted as Investigator Initiated Trial (IIT) and sponsored by the Bayer AG
Status	Recruiting completed
Steering Committee	Univ.-Prof. Dr. med. Philipp S. Wild, M.Sc., Mainz, Univ.-Prof. Dr. med. Stavros V. Konstantinides, Mainz, Univ.-Prof. Dr. med. Stephan Rosenkranz, Köln, Dr. med. Matthias Held, Würzburg, PD Dr. med. Claudia Dellas, Göttingen, Univ.-Prof. Dr. med. Ralf Ewert, Greifswald, Univ.-Prof. Dr. med. Ardeshir Ghofrani, Giessen, Univ.-Prof. Dr. med. Ekkehard Gruenig, Heidelberg, Univ.-Prof. Dr. med. Marius Hoeper, Hannover, PD Dr. med. Frank Langer, Homburg/Saar, Dr. med. Mareike Lankeit, Mainz, PD Dr. med. Hanno Leuchte, München, Univ.-Prof. Dr. med. Eckhard Mayer, Bad Nauheim, Dr. med. Claus Neurohr, München, PD Dr. med. Frank Reichenberger, München, PD Dr. med. Heinrike Wilkens, Homburg/Saar