Follow-Up after Acute Pulmonary Embolism (FOCUS) - a Prospective Observational Multicenter Cohort Study

German Clinical Trials registry: DRKS00005939

Chronic thromboembolic pulmonary hypertension (CTEPH) may result from incomplete resolution of pulmonary embolism (PE). CTEPH is a serious, often lethal disease, but advances in surgical, interventional and medical treatment are continuing to improve outcomes. The FOCUS study has been designed to fulfill all the high standards needed to determine the true incidence of CTEPH and its predictors. The main objective is to determine, over a 2-year follow-up period, the incidence of CTEPH or of “post-PE impairment” (based, for the first time, on predefined clinical, functional and hemodynamic criteria), after an index episode of acute symptomatic PE. FOCUS is a prospective, multicenter, observational cohort study. A total of 1000 patients – “all-comers” with acute PE - will be enrolled in 15 high-volume German centers. Diagnostic and therapeutic procedures will follow the high standards of care at the participating institutes (all of which are expert centers for PE and pulmonary hypertension in Germany) and be in accordance with current European guidelines. In addition, biobanking will be coordinated by the CTH as part of the FOCUS-BioSeq project.

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