Trial document




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  DRKS00007398

Trial Description

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Title

Patient Reported Outcome in Bioresorbable Vascular Scaffold

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Trial Acronym

PRO_BVS

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URL of the Trial

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Brief Summary in Lay Language

The study assesses changes of Health Related Quality of Life and Mental Distress in conjunction with Illness perception patterns after implantation of bioresorbable stent devices. Patients are invited to answer questionnaires after intervention and 1, 6, 12 and 24 months later. The study aims to evaluate the success of therapy in a patient centred way.

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Brief Summary in Scientific Language

The study aims to assess Health related Quality of Life, Mental in conjunction with illness perception patterns in patients with Coronary Artery Disease after implantation of bioresorbable vascular scaffold stent devices.
We plan to include 150 patients treated with Absorb bioresorbable stent devices. Participants are invited to answer the MacNew Health Related Quality of Life questionnaire, the HADS questionnaire and the Brief Illness perception questionnaire after PCI and 1, 6, 12, and 24 months later. In addition we collect data about clinical status (Angina pectoris, dyspnoea) and about Major Cardiac Events (myocardial infarction, revascularisation, cardiac death) in the follow up period. The longitudinal study design allows not only to describe changes in patient reported outcome measures but also to prove causal relationships between symptom burden, illness beliefs and patient-centred health status measures.

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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

  •   DRKS00007398
  •   2014/11/11
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  •   yes
  •   Approved
  •   EK-14-073-VK, Ethikkommision der Stadt Wien
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Secondary IDs

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Health Condition or Problem studied

  •   I25.1 -  Atherosclerotic heart disease
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Interventions/Observational Groups

  •   Assessment of Health Related Quality of Life, Mental Distress and Illness perception in patients with Coronary Artery disease after PCI with bioresorbable vascular scaffold
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Characteristics

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

Changes of MacNew Health Related Quality of Life after 1,6,12 and 24 month after PCI

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Secondary Outcome

Changes in HADS Mental Distress and BIPQ illness perception 1,6,12 and 24 months after PCI

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Countries of Recruitment

  •   Austria
  •   Germany
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Locations of Recruitment

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

  •   Actual
  •   2014/11/15
  •   150
  •   Multicenter trial
  •   International
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Inclusion Criteria

  •   Both, male and female
  •   18   Years
  •   80   Years
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Additional Inclusion Criteria

Coronary Artery disease and Implantation of bioresorbable vascular Absorb scaffold

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Exclusion Criteria

acute myocardial infarction,

percutaneus coronary intervention <6 months before inclusion,

insufficient German language skills to answer questionnaires

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Addresses

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    • Karl Landsteiner Institut für Wissenschaftliche Forschung in der Klinischen Kardiologie
    • Heinrich-Collin-Str. 30
    • 1140  Wien
    • Austria
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    • Karl Landsteiner Institut für Wissenschaftliche Forschung in der Klinischen Kardiologie
    • Mr.  Dr.  Oliver  Friedrich 
    • Heinrich-Collin-Str. 30
    • 1140  Wien
    • Austria
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    • Karl Landsteiner Institut für Wissenschaftliche Forschung inder Klinischen Kardiologie
    • Mr.  Dr.  Oliver  Friedrich 
    • Heinrich-Collin-Str. 30
    • 1140  Wien
    • Austria
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Sources of Monetary or Material Support

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    • Karl Landsteiner Gesellschaft, Karl Landsteiner Institut für Wissenschaftliche Forschung in der Klinischen Kardiologie
    • Heinrich-Collin-Str. 30
    • 1140  Wien
    • Austria
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    • Abbott GmbH Austria, Abbott Vascular
    • Perfektastr. 84A
    • 1230  Wien
    • Austria
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Status

  •   Recruiting ongoing
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Trial Publications, Results and other Documents

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