Clinical trial NCT00558779: Surgical Manipulation of the Aorta and Cerebral Infarction
Official title: Surgical Manipulation of the Ascending Aorta and Cerebral Infarction Following CABG
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Coronary Heart Disease
Stroke
Cerebral Infarction
Keywords: Coronary artery bypass
off pump coronary artery bypass grafting (OPCAB)
Lead sponsor: University of Wuerzburg
Sponsor class: OTHER
Collaborators: name: Deutsche Stiftung für Herzforschung
First posted: 2007-11-15
Enrollment: 200
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

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.

Eligibility criteria: 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.

Primary outcomes:
measure: occurrence and number of cerebral infarctions assessed by magnetic resonance imaging
timeFrame: 2-7 days after surgery
Secondary outcomes:
measure: mortality
timeFrame: within hospital stay following surgery
measure: stroke
timeFrame: within hospital stay following surgery
measure: delirium
timeFrame: within hospital stay following surgery
measure: neurocognitive performance
timeFrame: within hospital stay following surgery
measure: multi-organ failure
timeFrame: within hospital stay following surgery
measure: myocardial infarction
timeFrame: within hospital stay following surgery
measure: completeness of revascularisation
timeFrame: within hospital stay following surgery
Other outcomes:
Locations:
city: Wuerzburg
country: Germany
facility: Department of Cardiothoracic Surgery, University Hospital Wuerzburg
Study officials:
affiliation: Department of Cardiothoracic Surgery
name: Wilko Reents, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.