Trial document




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  DRKS00006773

Trial Description

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Title

Peripheral artery occlusive disease as index for kardiovascular and cerebrovascular events

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Trial Acronym

Allo-Study

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URL of the Trial

http://folgt

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Brief Summary in Lay Language

Arteriosclerosis is identified as leading cause for peripheral artery occlusive disease. As well known arteriosclerosis is a progressive disease affecting vessels on various segments in the body.
Other manifestations of arteriosclerosis are cardiovascular or cerebrovaskulär diseases. Main goal of this study is to determine the prevalence of peripheral artery occlusive disease in the older population and to calculate the risk of suffering a stroke or myocardial infarction after 1 or 3 years compared to a population without peripheral artery occlusive disease.

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Brief Summary in Scientific Language

It is well known that patients suffering from peripheral artery occlusive disease are more likely to suffer as well from cardiovascular or cerebrovascular diseases and that there is connection between peripheral artery occlusive disease and carciovascular mortality. Therefore, peripheral artery occlusive disease (PAOD) and a reduced ankle-brachial-pressure-index (ABI) are believed to be an index for cardiovascular events.
Main Goal of this study is to determine the prevalence of PAOD in the older population and to calculate the risk of suffering a stroke or myocardial infarction after 1 or 3 years compared to a population without PAOD.

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Organizational Data

  •   DRKS00006773
  •   2014/10/29
  •   [---]*
  •   yes
  •   Approved
  •   14-277, Ethik-Kommission der Medizinischen Fakultät der Universität zu Köln
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Secondary IDs

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

  •   I70.21 -  [generalization I70.2: Atherosclerosis of arteries of extremities]
  •   I21.0 -  Acute transmural myocardial infarction of anterior wall
  •   I63.3 -  Cerebral infarction due to thrombosis of cerebral arteries
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Interventions/Observational Groups

  •   All inhabitants of the Alloheim senior residences in Germany are going to be examined if there is PAOD. After one and three years the mortality, suffering a stroke or a myocardial infarction of the inhabitants with PAOD is determined and compared to the inhabitants without PAOD.
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Characteristics

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

Prevalence of peripheral artery occlusive disease and mortality (and the cause of death, if patient died) over time determined one and three years after first contact using the certificate of death (if existing).

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Secondary Outcome

cardiovascular oder cerebrovascular events

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

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Recruitment

  •   Actual
  •   2014/11/01
  •   5500
  •   Multicenter trial
  •   National
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Inclusion Criteria

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

Inhabitants of Alloheim senior residences who gave their consent

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Exclusion Criteria

no consent given

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Addresses

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    • Alloheim Senioren-Residenzen GmbHHauptverwaltung
    • Zollhof 30
    • 40221  Düsseldorf
    • Germany
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    •   [---]*
    •   [---]*
    •   [---]*
    •   [---]*
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    • Universitätsklinikum Köln Abteilung für Gefäßchirurgie
    • Mr.  Dr.   Payman  Majd 
    • Kerpener Str. 62
    • 50924  Köln
    • Germany
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    • Universitätsklinikum Köln
    • Mr.  Dr  Payman  Majd 
    • Kerpener Str. 62
    • 50924  Köln
    • Germany
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Sources of Monetary or Material Support

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    • Alloheim Senioren-Residenzen GmbHHauptverwaltung
    • Zollhof 30
    • 40221  Düsseldorf
    • Germany
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    •   [---]*
    •   [---]*
    •   [---]*
    •   [---]*
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Status

  •   Recruiting complete, follow-up continuing
  •   [---]*
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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.