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FOCUS BioSeq

Investigation of biochemical and genetic markers in the disease course of acute pulmonary embolism and pulmonary hypertension.

  • Study directors:

    • Univ.-Prof. Dr. med. Philipp Wild, M.Sc.
    • Univ.-Prof. Dr. Stavros Konstandinides

  • External study centers:

    • Klinikum München-Bogenhausen (Prof. Meyer)
    • DRK Kliniken Berlin Westend (Dr. Opitz)
    • Universitätsklinikum Leipzig (Dr. Seyfarth)
    • Universitätsmedizin Greifswald (Prof. Ewert)
    • Universitätsklinikum Gießen und Marburg GmbH (Prof. Ghofrani)
    • Klinikum Würzburg Mitte gGmbH (Dr. Matthias Held)
    • Universitätsklinikum Dresden (Dr. Halank)

  • www.germanctr.de ID: DRKS00005939

Subject

Investigation of biochemical and genetic markers in the disease course of acute pulmonary embolism and pulmonary hypertension

Study design

Multicenter prospective observational study, substudy with biobanking

Study participants

350 patients diagnosed with acute pulmonary embolism

Status

Follow-up

Objectives

  • Better understanding of the molecular and biochemical basis for the risks, development and clinical course of acute pulmonary embolism and pulmonary hypertension
  • Development of diagnostic tests for early detection of acute pulmonary embolism and pulmonary hypertension
  • Validation of new preventive and therapeutic approaches, drugs and therapies for the treatment of acute pulmonary embolism and pulmonary hypertension

Study procedure

2 years of clinical follow-up per participant, 4 years of biomolecular and genetic analyses

Summary

In most cases, pulmonary embolism results from embolization of thrombi from the deep veins of the leg, pelvis, or, less commonly, arm and shoulder. The clinical picture of VTE (venous thromboembolism) may be followed by a decreased physical and psychological resilience as well as an increased risk of recurrence of VTE events, and even the development of chronic thromboembolic pulmonary hypertension (CTEPH).

The objective of the FOCUS study is to assess incidence and survival in chronic thromboembolic pulmonary hypertension (CTEPH) and loss of pulmonary function after acute pulmonary embolism. During follow-up, the study team will contact participants, document clinical follow-up examinations and collect questionnaires with information on quality of life.

Based on biochemical and genetic analyses, the FOCUS BioSeq study seeks to identify and evaluate novel and established biochemical and genetic markers in acute pulmonary embolism and its secondary diseases. Blood and urine will be processed and stored for the establishment of a central biobank at the event of acute pulmonary embolism as well as at 3, 12, and 24 months of follow-up. The plasma proteome of the blood (portion of the blood without cells) will then be examined in laboratory analyses over the course of four years for the quantitative detection of single or multiple proteins as well as the detection of protein patterns. Together with genome-wide association studies and other sequencing analyses, the so-called OMIKS analyses will be combined with a focus on blood coagulation, immunity, inflammation and the cardiovascular diseases. p>

Using biostatistical methods, these laboratory analyses can contribute significantly to a comprehensive understanding of causes of development and progression of pulmonary embolism, thus providing a basis for future preventive and therapeutic approaches.

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