Trial document





This trial has been registered retrospectively.
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  DRKS00014665

Trial Description

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Title

Evaluation study of prevalence of sleep-disordered breathing in patients requiring surgical myocardial revascularization and analysis of incidence of postoperative atrial fibrillation in associated with sleep-disordered breathing

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Trial Acronym

SDB-CABG-BO1

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URL of the Trial

[---]*

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Brief Summary in Lay Language

Sleep-disordered breathing is highly common in patients with cardiovascular disease and sleep-disordered breathing is believed to promote cardiac dysrhythmia. Postoperative cardiac dysrhythmia after heart surgery is a major comorbidity resulting in prolonged ICU (Intensive Care Unit) or Hospital stay and even has impact on survival. Scientific literature on prevalence of sleep-disordered breathing in patients with cardiovascular disease requiring heart surgery is scarce and its association with incidence of postoperative atrial fibrillation is not well studied. This study aims to prospectively investigate prevalence of sleep-disordered breathing in patients with cardiovascular disease requiring heart surgery and analyze and association with incidence of postoperative atrial fibrillation in these patients.

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Brief Summary in Scientific Language

Sleep-disordered breathing is highly common in patients with cardiovascular disease and sleep-disordered breathing is believed to promote cardiac dysrhythmia. Postoperative cardiac dysrhythmia after heart surgery is a major comorbidity resulting in prolonged ICU or Hospital stay and even has impact on survival. Scientific literature on prevalence of sleep-disordered breathing in patients with cardiovascular disease requiring heart surgery is scarce and its association with incidence of postoperative atrial fibrillation is not well studied. This study aims to prospectively investigate prevalence of sleep-disordered breathing in patients with cardiovascular disease requiring heart surgery and analyze and association with incidence of postoperative atrial fibrillation in these patients.

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Organizational Data

  •   DRKS00014665
  •   2018/05/14
  •   [---]*
  •   yes
  •   Approved
  •   17-262, Ethikkommission der Medizinischen Fakultät der Ruhr-Universität Bochum, Sitz Bad Oeynhausen
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Secondary IDs

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

  •   G47.3 -  Sleep apnoea
  •   I48 -  Atrial fibrillation and flutter
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Interventions/Observational Groups

  •   This study prospectively investigates prevalence of sleep-disordered breathing in patients undergoing heart surgery for myocardial revascularization of coronary artery disease. All patients older than 18 years and willing to participate in this study will receive an unattended cardiorespiratory polygraph prior to heart surgery. This study will then analyze associations of sleep-disordered breathing with incidence of postoperative atrial fibrillation.
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Characteristics

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

Prevalence of sleep-disordered breathing in patients undergoing heart surgery and collection of electrocardiographical rate of postoperative onset of atrial fibrillation.

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Secondary Outcome

Investigation whether onset of postoperative atrial fibrillation has influence of the length of ICU (Intensive Care Unit) or hospital stay and whether additional examinations or procedures become necessary such as cardioversion, additional medication or other treatments

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • University Medical Center 
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Recruitment

  •   Actual
  •   2018/01/01
  •   1000
  •   Monocenter trial
  •   National
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Inclusion Criteria

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

No known atrial fibrillation, planned heart surgery, no known sleep-disordered breathing with and without treatment

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Exclusion Criteria

Known atrial fibrillation, known sleep-disordered breathing with and without treatment

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Addresses

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    • Herz- und Diabeteszentrum Nordrhein-Westfalen
    • Georgstr. 11
    • 32545  Bad Oeynhausen
    • Germany
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    • Kardiologische Klinik, Herz- und Diabeteszentrum NRW, Universitätsklinik der Ruhr-Universität Bochum
    • Ms.  Astrid  Kleemeyer 
    • Georgstr. 11
    • 32545  Bad Oeynhausen
    • Germany
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    • Herz- und Diabeteszentrum Nordrhein-Westfalen Universitätsklinikum der RUB
    • Mr.  PD Dr. med.  Henrik  Fox 
    • Georgstr. 11
    • 32545  Bad Oeynhausen
    • Germany
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Sources of Monetary or Material Support

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    • Herz- und Diabeteszentrum Nordrhein-WestfalenUniversitätsklinikum der RUB
    • Mr.  PD Dr. med.  Henrik  Fox 
    • Georgstr. 11
    • 32545  Bad Oeynhausen
    • 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.