Trial document




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  DRKS00017269

Trial Description

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Title

Cardiovascular Long-term Outcome in Patients Previously Undergoing Coronary CT Examination

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Trial Acronym

CLEO-PATRA

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URL of the Trial

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Brief Summary in Lay Language

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Brief Summary in Scientific Language

The main objective of the CLEO-PATRA study is to assess the cardiovascular long-term outcome in patients who previously underwent clinically indicated coronary CT examina-tions between 2009 and 2014.
In detail, the main objective is to determine the mortality rate, the rate of cardiovascular hospital admissions and the rate of cardiovascular procedural interventions occurring since the index CT examination.

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Organizational Data

  •   DRKS00017269
  •   2019/05/29
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  •   no
  •   Approved
  •   25_19 B, Ethik-Kommission der Friedrich-Alexander-Universität Erlangen-Nürnberg
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Secondary IDs

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Health Condition or Problem studied

  •   I25.0 -  Atherosclerotic cardiovascular disease, so described
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Interventions/Observational Groups

  •   To assess the long-term outcomes in patients undergoing coronary CT exami-nations with regard to mortality, cardiovascular hospital admissions and cardi-ovascular procedural interventions.

    Patients with previous coronary CT examination at study site between 2009 and 2014

    11 study sites that have participated in the Cardio CT Registry (Stiftung IHF)

    Baseline data of the Cardio CT registry:
    Patient demographics
    Medical history
    Cardiovascular risk factors
    Procedural details of the coronary CT examination
    Follow-up data:
    Mortality
    Cardiovascular hospital admissions since baseline
    Cardiovascular procedural interventions since baseline
    Acute renal failure since baseline




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Characteristics

  •   Non-interventional
  •   Epidemiological study
  •   Other
  •   Open (masking not used)
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  •   Other
  •   Other
  •   Other
  •   N/A
  •   No
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Primary Outcome

The main objective of the CLEO-PATRA study is to assess the cardiovascular long-term outcome in patients who previously underwent clinically indicated coronary CT examina-tions between 2009 and 2014.
In detail, the main objective is to determine the mortality rate, the rate of cardiovascular hospital admissions and the rate of cardiovascular procedural interventions occurring since the index CT examination.

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Secondary Outcome

Thus, a further objective of this study is to build a system for the computer assisted anal-ysis of patient data from clinical cardiology. With the help of algorithms, information can be drawn from various sources, such as coronary CT examinations, laboratory parameters or the patient’s medical history, that is expected to provide prognostic clues to future cardiologic risks. Subsequently, using the given information and the patient’s known course of his disease, a computer system can be trained that may be able to draw con-clusions and predict cardiac risks. Siemens Healthineers will be provided with a complete-ly anonymized data set of the study data to investigate the predictive power of coronary CT examinations using machine-learning approaches.

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

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Recruitment

  •   Planned
  •   2019/06/15
  •   5000
  •   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

Patients fulfilling the following criteria:
• 18+ years
• Patient had coronary CT examination at study site between 2009 and 2014
• Written informed consent for participation in observational study (incl. telephone follow-ups)
No explicit medical exclusion criteria are stated to avoid selection bias.

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Exclusion Criteria

No explicit medical exclusion criteria are stated to avoid selection bias.

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Addresses

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    • IHF GmbH
    • Bremserstraße 79
    • 67063  Ludwigshafen
    • Germany
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    • IHF GmbH
    • Mr.  Sebastian  Diebold 
    • Bremserstraße 79
    • 67063  Ludwigshafen
    • Germany
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    • IHF GmbH
    • Mr.  Sebastian  Diebold 
    • Bremserstraße 79
    • 67063  Ludwigshafen
    • Germany
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Sources of Monetary or Material Support

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    • Siemens Healtcare GmbH
    • Henkestraße 127
    • 91052  Erlangen
    • Germany
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Status

  •   Recruiting planned
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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.