Trial document




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  DRKS00005939

Trial Description

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Title

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

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Trial Acronym

FOCUS

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URL of the Trial

[---]*

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Brief Summary in Lay Language

In this observational study emphasis is put on the registration of persistent sequelae after an acute episode of pulmonary embolism. Especially markers indicative of the development of chronic postembolic pulmonary hypertension will be looked for.

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Brief Summary in Scientific Language

Objectives: To determine, over a 2-year follow-up period, the incidence of chronic thromboembolic pulmonary hypertension (CTEPH) or post-PE impairment after an index episode of acute pulmonary embolism (PE).
Population: A total of 1000 patients with acute symptomatic PE will be included in the study:
Inclusion Criteria
1) Objectively confirmed diagnosis of acute symptomatic PE by multidetector computed tomography (CT), pulmonary angiography, or V/Q lung scan according to established diagnostic criteria, with or without symptomatic deep vein thrombosis;
2) Ability of subject to understand character and individual consequences of participation in the study;
3) Written informed consent available before enrollment in the study;
4) Age ≥18 years.
Exclusion Criteria
1) Subjects unwilling or unable to sign the informed consent form;
2) Patients in whom the diagnosis of PE is an incidental finding during diagnostic workup for another disease;
3) Patients with previously diagnosed chronic thromboembolic pulmonary hypertension;
4) No subject will be enrolled in this study more than once.
Primary Outcomes:
1) Confirmed diagnosis of chronic thromboembolic pulmonary hypertension (CTEPH) at any time during 2 year-follow-up;
2) Post-PE impairment at >1 follow-up visit, defined by deterioration (compared to the previous visit or to the findings at discharge) by at least one category, or persistence of the greatest-severity category, in >1 of the “a” (echocardiographic) parameters plus deterioration by at least one category (or persistence of the greatest-severity category) in >1 of the “b” (clinical, functional, or laboratory) parameters

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Do you plan to share individual participant data with other researchers?

[---]*

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Description IPD sharing plan:

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Organizational Data

  •   DRKS00005939
  •   2014/07/03
  •   [---]*
  •   yes
  •   Approved
  •   837.440.13 (9125), Ethik-Kommission bei der Landesärztekammer Rheinland-Pfalz
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Secondary IDs

  • [---]*
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Health Condition or Problem studied

  •   I26.9 -  Pulmonary embolism without mention of acute cor pulmonale
  •   I27 -  Other pulmonary heart diseases
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Interventions/Observational Groups

  •   Patients with confirmed acute pulmonary embolism will be treated according to current guidleines and invited to control vists in the clinic after 3, 12 and 24 months where data, including the results of a 6-minutes walking test and cardiopulmonary exercise testing will be recorded and 2 QoL questionnaires will be administered to the patients
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Characteristics

  •   Non-interventional
  •   Other
  •   Single arm study
  •   Open (masking not used)
  •   [---]*
  •   Uncontrolled/Single arm
  •   Prognosis
  •   Single (group)
  •   N/A
  •   N/A
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Primary Outcome

1) Confirmed diagnosis of chronic thromboembolic pulmonary hypertension (CTEPH) at any follow-up visit (at 3, 12 und 24 months) during 2 year-follow-up;
2) Post-PE impairment at ≥1 follow-up visit, defined by deterioration - compared to the previous visit or to the findings at discharge - by at least one category, or persistence of the greatest-severity category, in ≥1 of the echocardiographic parameters PLUS deterioration by at least one category or persistence of the greatest-severity category in ≥1 of the clinical, functional, or laboratory parameters

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Secondary Outcome

Overall mortality, recurrent deep vene thrombosis od pulmonal embolism, stroke, functional impairment defined by oxygen comsumption during exercise test, 6-minute walkingtest and Borg's dyspnoea Index, echcardiographic evidence of pulmonal hypertension, changes in quality of life at 3, 12 and 24 months

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • University Medical Center 
  • University Medical Center 
  • University Medical Center 
  • Medical Center 
  • University Medical Center 
  • University Medical Center 
  • University Medical Center 
  • University Medical Center 
  • University Medical Center 
  • Medical Center 
  • University Medical Center 
  • Medical Center 
  • Medical Center 
  • University Medical Center 
  • University Medical Center 
  • Medical Center 
  • Medical Center 
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Recruitment

  •   Actual
  •   2014/09/29
  •   1000
  •   Multicenter trial
  •   National
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Inclusion Criteria

  •   Both, male and female
  •   18   Years
  •   no maximum age
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Additional Inclusion Criteria

1) Objectively confirmed diagnosis of acute symptomatic PE by multidetector computed tomography (CT), pulmonary angiography, or V/Q lung scan according to established diagnostic criteria (1), with or without symptomatic deep vein thrombosis;
2) Ability of subject to understand character and individual consequences of participation in the study;
3) Written informed consent must be available before enrollment in the study;
4) Age ≥18 years

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Exclusion Criteria

1) Subjects unwilling or unable to sign the informed consent form;
2) Patients in whom the diagnosis of PE is an asymptomatic incidental finding during diagnostic workup for another disease;
3) Patients with previously diagnosed chronic thromboembolic pulmonary hypertension;
4) No subject will be allowed to enroll in this study more than once.

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Addresses

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    • Universitätsmedizin der Johannes Gutenberg-Universität Mainz
    • Langenbeckstraße 1
    • 55131  Mainz
    • Germany
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    • Centrum für Thrombose und Hämostase,Universitätsmedizin der Johannes Gutenberg-Universität Mainz
    • Mr.  Univ. Prof., Dr. med.  Stavros   Konstantinides 
    • Langenbeckstraße 1
    • 55131  Mainz
    • Germany
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    • Centrum für Thrombose und HämostaseUniversitätsmedizin der Johannes Gutenberg-Universität Mainz
    • Mr.  Prof.  Stavros  Konstantinides 
    • Langenbeckstraße 1
    • 55131  Mainz
    • Germany
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Sources of Monetary or Material Support

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    • Bundesministerium für Bildung und Forschung Dienstsitz Berlin
    • Friedrichstraße 130 B
    • 10117  Berlin
    • Germany
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    • Bayer Vital GmbH
    • 51368   Leverkusen
    • Germany
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    •   [---]*
    •   [---]*
    •   [---]*
    •   [---]*
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Status

  •   Recruiting complete, follow-up complete
  •   2020/09/08
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* This entry means the parameter is not applicable or has not been set.