Trial document





This trial has been registered retrospectively.
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  DRKS00019903

Trial Description

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Title

Influence of Patient Knowledge of Individual Serum LDL-C Level and Treatment Goal on Quality of Lipid-lowering Therapy in High Risk Patients with Cardiovascular Disease

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Trial Acronym

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URL of the Trial

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Brief Summary in Lay Language

We aim to analyse the knowledge of lipid-lowering and anti-diabetic treatment goals and perceived level of information in very high risk patients with cardiovascular disease (CVD) and diabetes mellitus (DM). A questionnaire assessing the level of information with regard to predefined disease-related topics will be developed and reviewed by clinical experts. Additionally, participants will be asked to name their treatment goal for lipid-lowering and anti-diabetic therapy. Correct goal is defined according to European Society of Cardiology guidelines. In a study the questionnaire will be handed out to patients that are treated for a cardiovascular disorder and have previously been diagnosed with CVD and DM.

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Brief Summary in Scientific Language

We aim to analyse the knowledge of lipid-lowering and anti-hyperglycaemic treatment goals and perceived level of information in very high risk patients with cardiovascular disease (CVD) and diabetes mellitus (DM). A questionnaire assessing the level of information with regard to predefined disease-related topics will be developed and reviewed by clinical experts. Additionally, participants will be asked to name their treatment goal for lipid-lowering and anti-hyperglycaemic therapy. Correct goal is defined according to European Society of Cardiology guidelines. In a prospective observational study the questionnaire will be handed out to patients that are treated for a cardiovascular disorder and have previously been diagnosed with CVD and DM.

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Forwarding of patient-related data:

No

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Description IPD sharing plan:

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Organizational Data

  •   DRKS00019903
  •   2019/11/26
  •   [---]*
  •   yes
  •   Approved
  •   2019-401-KFogU, Ethik-Kommission an der Medizinischen Fakultät der Heinrich-Heine-Universität Düsseldorf
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Secondary IDs

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Health Condition or Problem studied

  •   I25.1 -  Atherosclerotic heart disease
  •   I70.2 -  Atherosclerosis of arteries of extremities
  •   I65.2 -  Occlusion and stenosis of carotid artery
  •   E10 -  Type 1 diabetes mellitus
  •   E11 -  Type 2 diabetes mellitus
  •   E12 -  Malnutrition-related diabetes mellitus
  •   E13 -  Other specified diabetes mellitus
  •   E14 -  Unspecified diabetes mellitus
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Interventions/Observational Groups

  •   A questionnaire assessing the level of information with regard to predefined disease-related topics will be handed out to patients that are treated for a cardiovascular disorder and have previously been diagnosed with cardiovascular disease and diabetes mellitus. Additionally, participants will be asked to name their treatment goal for lipid-lowering and anti-hyperglycaemic therapy.
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Characteristics

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

level of information with regard to predefined disease-related topics

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Secondary Outcome

knowledge of lipid-lowering and anti-diabetic treatment goals

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • Medical Center 
  • Doctor's Practice 
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Recruitment

  •   Actual
  •   2019/05/16
  •   500
  •   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

cardiovascular disease and diabetes mellitus

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Exclusion Criteria

dementia

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Addresses

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    • Universitätsklinikum Düsseldorf
    • Moorenstr. 5
    • 40225  Düsseldorf
    • Germany
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    • Universitätsklinikum Düsseldorf, Klinik für Kardiologie, Pneumologie und Angiologie
    • Mr.  Dr. med.  Maximilian  Brockmeyer 
    • Moorenstraße 5
    • 40225  Düsseldorf
    • Germany
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    • Klinik für Kardiologie, Pneumologie und Angiologie
    • Mr.  Dr. med.  Maximilian  Brockmeyer 
    • Moorenstraße 5
    • 40225  Düsseldorf
    • Germany
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Sources of Monetary or Material Support

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    • Universitätsklinikum Düsseldorf
    • Moorenstr. 5
    • 40225  Düsseldorf
    • Germany
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Status

  •   Recruiting ongoing
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Trial Publications, Results and other Documents

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* This entry means the parameter is not applicable or has not been set.