Trial document




drksid header

  DRKS00000521

Trial Description

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Title

Coronary artery bypass graft surgery in patients with asymptomatic carotid stenosis

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Trial Acronym

CABACS

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URL of the Trial

http://www.cabacs.de

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Brief Summary in Lay Language

Of patients undergoing coronary artery bypass graft (CABG) surgery, 6-8% present with a concomitant high grade carotid stenosis.
To date, it remains unknown whether the common practice of a combined carotid endarterectomy is superior to isolated CABG or staged procedures. The objective of this study therefore is to investigate the safety and efficacy of isolated CABG versus combined CEA and CABG in patients with high-grade (≥80%) asymptomatic carotid stenosis.
CABACS is a randomised, controlled clinical study in about 35 German cardio-thoracic surgery centers scheduled to start in September 2010. Over a projected period of 3 years, 1160 patients will be ranomized.

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Brief Summary in Scientific Language

Of patients undergoing coronary artery bypass graft (CABG) surgery, 6-8% present with a concomitant high grade carotid stenosis.
To date, no clinical study has determined whether the common practice of a combined carotid endarterectomy (CEA), is superior to isolated CABG or staged procedures. The objective of this study therefore is to investigate the safety and efficacy of isolated CABG versus combined CEA and CABG in patients with high-grade (≥80%) asymptomatic carotid stenosis.
CABACS is a randomised, controlled clinical study in about 35 German cardio-thoracic surgery centers scheduled to start in September 2010. Over a projected period of 3 years, 1160 patients will be ranomized.

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Organizational Data

  •   DRKS00000521
  •   2010/08/20
  •   [---]*
  •   yes
  •   Approved
  •   10/4325, Ethik-Kommission der Medizinischen Fakultät der Universität Duisburg-Essen
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Secondary IDs

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

  •   I25 -  Chronic ischaemic heart disease
  •   I65.2 -  Occlusion and stenosis of carotid artery
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Interventions/Observational Groups

  •   coronary artery bypass graft surgery without carotid endarterectomy
  •   combined carotid artery bypass graft (CABG) surgery and carotid endarterectomy (CEA)
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Characteristics

  •   Interventional
  •   [---]*
  •   Randomized controlled trial
  •   Open (masking not used)
  •   [---]*
  •   Active control (effective treament of control group)
  •   Treatment
  •   Factorial
  •   IV
  •   [---]*
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Primary Outcome

The primary efficacy endpoint is the event rate of nonfatal strokes or deaths from any cause (whatever occurs first) within 30 days after the intervention (either isolated CABG or synchronous CABG + CEA).

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Secondary Outcome

Secondary efficacy endpoints are single components of the primary endpoint, myocardial infarction, technical failures, duration of ventilatory support, change of cognitive performance on the Demtec scale and observations at different time points.

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Countries of Recruitment

  •   Germany
  •   Czech Republic
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Locations of Recruitment

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

  •   Actual
  •   2010/12/01
  •   316
  •   Multicenter trial
  •   International
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Inclusion Criteria

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

Key inclusion criteria:
1. Identification of a ≥80% stenosis (ECST criteria) of the extracranial carotid artery in a patient scheduled for coronary artery bypass graft (CABG) surgery with the stenosis being asymptomatic for the past 180 days
2. Carotid stenosis treatable with CEA
3. Written informed consent
4. Male or female patients of age ≥18 years

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Exclusion Criteria

Key exclusion criteria:
1. Stenosis related neurological symptoms within the previous 180 days
2. Non-atherosclerotic origin of stenosis
3. NSTEMI within the past 48 hours, STEMI within the past 7 days or hemodynamically unstable patients
4. Modified Rankin Scale score >3 or severe aphasia

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Addresses

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    • Universitätsklinikum Essen
    • Hufelandstraße 55
    • 45147  Essen
    • Germany
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    • Neurologische Klinik Universitätsklinikum Essen
    • Mr.  Prof. Dr. med.  Christian  Weimar 
    • Hufelandstr. 55
    • 45122  Essen
    • Germany
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    • Klinik für Thorax und kardiovaskuläre Chirurgie Universitätsklinikum Essen
    • Mr.  Dr. med.  Stephan  Knipp 
    • Hufelandstr. 55
    • 45122  Essen
    • Germany
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Sources of Monetary or Material Support

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    • Deutsche Forschungsgemeinschaft
    • Kennedyallee 40
    • 53175  Bonn
    • Germany
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Status

  •   Recruiting stopped after recruiting started
  •   [---]*
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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.