Surgical Manipulation of the Aorta and Cerebral Infarction
NCT ID: NCT00558779
Last Updated: 2007-11-22
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE2
200 participants
INTERVENTIONAL
2007-11-30
2010-05-31
Brief Summary
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Detailed Description
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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.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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1
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)
2
CABG (coronary artery bypass grafting)
conventional CABG with cardiopulmonary bypass
Interventions
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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)
CABG (coronary artery bypass grafting)
conventional CABG with cardiopulmonary bypass
Eligibility Criteria
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Inclusion Criteria
* history of stroke
* cerebrovascular artery disease with stenosis \> 50%
* peripheral arterial disease.
Exclusion Criteria
* unstable angina
* reoperation
* concomitant valvular disease requiring surgery
* implanted pacemaker or other incorporated ferromagnetic material
* claustrophobia.
ALL
No
Sponsors
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Deutsche Stiftung für Herzforschung
OTHER
University of Wuerzburg
OTHER
Principal Investigators
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Wilko Reents, MD
Role: PRINCIPAL_INVESTIGATOR
Department of Cardiothoracic Surgery
Locations
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Department of Cardiothoracic Surgery, University Hospital Wuerzburg
Würzburg, , Germany
Countries
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Central Contacts
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Facility Contacts
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Wilko Reents, MD
Role: primary
References
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Stamou SC, Hill PC, Dangas G, Pfister AJ, Boyce SW, Dullum MK, Bafi AS, Corso PJ. Stroke after coronary artery bypass: incidence, predictors, and clinical outcome. Stroke. 2001 Jul;32(7):1508-13. doi: 10.1161/01.str.32.7.1508.
Roach GW, Kanchuger M, Mangano CM, Newman M, Nussmeier N, Wolman R, Aggarwal A, Marschall K, Graham SH, Ley C. Adverse cerebral outcomes after coronary bypass surgery. Multicenter Study of Perioperative Ischemia Research Group and the Ischemia Research and Education Foundation Investigators. N Engl J Med. 1996 Dec 19;335(25):1857-63. doi: 10.1056/NEJM199612193352501.
Calafiore AM, Di Mauro M, Teodori G, Di Giammarco G, Cirmeni S, Contini M, Iaco AL, Pano M. Impact of aortic manipulation on incidence of cerebrovascular accidents after surgical myocardial revascularization. Ann Thorac Surg. 2002 May;73(5):1387-93. doi: 10.1016/s0003-4975(02)03470-7.
Sellke FW, DiMaio JM, Caplan LR, Ferguson TB, Gardner TJ, Hiratzka LF, Isselbacher EM, Lytle BW, Mack MJ, Murkin JM, Robbins RC; American Heart Association. Comparing on-pump and off-pump coronary artery bypass grafting: numerous studies but few conclusions: a scientific statement from the American Heart Association council on cardiovascular surgery and anesthesia in collaboration with the interdisciplinary working group on quality of care and outcomes research. Circulation. 2005 May 31;111(21):2858-64. doi: 10.1161/CIRCULATIONAHA.105.165030.
Bendszus M, Reents W, Franke D, Mullges W, Babin-Ebell J, Koltzenburg M, Warmuth-Metz M, Solymosi L. Brain damage after coronary artery bypass grafting. Arch Neurol. 2002 Jul;59(7):1090-5. doi: 10.1001/archneur.59.7.1090.
Other Identifiers
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F/13/03
Identifier Type: -
Identifier Source: secondary_id
49/07
Identifier Type: -
Identifier Source: org_study_id