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Surgical Manipulation of the Aorta and Cerebral Infarction

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00558779
Recruitment Status : Unknown
Verified November 2007 by University of Wuerzburg.
Recruitment status was:  Recruiting
First Posted : November 15, 2007
Last Update Posted : November 22, 2007
Deutsche Stiftung für Herzforschung
Information provided by:
University of Wuerzburg

Brief Summary:
The purpose of the study is to compare two surgical strategies for coronary artery bypass grafting with respect to the occurrence of cerebral infarctions made visible by magnetic resonance imaging

Condition or disease Intervention/treatment Phase
Coronary Heart Disease Stroke Cerebral Infarction Procedure: OBCAB (Off Pump Coronary Artery Bypass Grafting) Procedure: CABG (coronary artery bypass grafting) Phase 2

Detailed Description:

Stroke is one of the most devastating complications following coronary artery bypass grafting (CABG) with an overall incidence ranging from 2.0 % to 3.2 %. The presumed etiology for the majority of strokes after CABG is atheroembolism from the diseased aorta ascendens caused by surgical manipulation. Off-pump coronary artery bypass grafting (OPCAB) allows the construction of bypass grafts without surgical manipulation of the aorta. Yet a trial comparing different surgical strategies with stroke as the primary end point would require several thousand patients to achieve an adequate statistical power. The number of patients can be substantially reduced, if cerebral damage is assessed by diffusion-weighted magnetic resonance imaging (DW-MRI). Using DW-MRI we have recently demonstrated that 25% of a patient population undergoing CABG without an increased risk of stroke showed new cerebral infarctions. These new cerebral lesions all showed an embolic pattern, became visible at T2-weighted images and were clinically silent, e .g. did not cause a new focal neurologic deficit. Given the much higher frequency of cerebral lesions assessed by DW-MRI than clinically apparent stroke, DW-MRI is an ideal surrogate parameter for the assessment of cerebral damage in patients undergoing CABG.

The aim of the study is therefore, to investigate the influence of the surgical technique on the occurence of new ischemic cerebral lesions as assessed by DW-MRI in patients undergoing CABG in a prospective randomized setting. We hypothesize that OPCAB, which enables sparing of aortic manipulation, will reduce cerebral infarctions in patients with an increased risk for perioperative stroke.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 200 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Surgical Manipulation of the Ascending Aorta and Cerebral Infarction Following CABG
Study Start Date : November 2007
Estimated Study Completion Date : May 2010

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: 1 Procedure: OBCAB (Off Pump Coronary Artery Bypass Grafting)
OPCAB with sparing of aortic manipulation (eg, no aortic cannulation for cardiopulmonary bypass, no aortic cross-clamp, no side-clamping of the aorta). Graft anastomosis to the central circulation with y-grafts on the arteria thoracica interna or on the aorta with help of the Heart-string-system (Guidant)

Active Comparator: 2 Procedure: CABG (coronary artery bypass grafting)
conventional CABG with cardiopulmonary bypass

Primary Outcome Measures :
  1. occurrence and number of cerebral infarctions assessed by magnetic resonance imaging [ Time Frame: 2-7 days after surgery ]

Secondary Outcome Measures :
  1. mortality [ Time Frame: within hospital stay following surgery ]
  2. stroke [ Time Frame: within hospital stay following surgery ]
  3. delirium [ Time Frame: within hospital stay following surgery ]
  4. neurocognitive performance [ Time Frame: within hospital stay following surgery ]
  5. multi-organ failure [ Time Frame: within hospital stay following surgery ]
  6. myocardial infarction [ Time Frame: within hospital stay following surgery ]
  7. completeness of revascularisation [ Time Frame: within hospital stay following surgery ]

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • age > 72
  • history of stroke
  • cerebrovascular artery disease with stenosis > 50%
  • peripheral arterial disease.

Exclusion Criteria:

  • urgent or emergency operation
  • unstable angina
  • reoperation
  • concomitant valvular disease requiring surgery
  • implanted pacemaker or other incorporated ferromagnetic material
  • claustrophobia.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00558779

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Contact: Wilko Reents, MD 0049 - 931 - 201 - 33001

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Department of Cardiothoracic Surgery, University Hospital Wuerzburg Recruiting
Wuerzburg, Germany, 97080
Contact: Wilko Reents, MD    0049-931-201-33001   
Principal Investigator: Wilko Reents, MD         
Sponsors and Collaborators
University of Wuerzburg
Deutsche Stiftung für Herzforschung
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Principal Investigator: Wilko Reents, MD Department of Cardiothoracic Surgery

Layout table for additonal information Identifier: NCT00558779    
Other Study ID Numbers: 49/07
First Posted: November 15, 2007    Key Record Dates
Last Update Posted: November 22, 2007
Last Verified: November 2007
Keywords provided by University of Wuerzburg:
Coronary artery bypass
off pump coronary artery bypass grafting (OPCAB)
Additional relevant MeSH terms:
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Cerebral Infarction
Heart Diseases
Coronary Disease
Coronary Artery Disease
Myocardial Ischemia
Pathologic Processes
Cardiovascular Diseases
Vascular Diseases
Arterial Occlusive Diseases
Brain Infarction
Brain Ischemia
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases