Cerebral Infarction, Coronary Heart Disease, Stroke
Conditions
Keywords
Coronary artery bypass, off pump coronary artery bypass grafting (OPCAB)
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.
Interventions
PROCEDUREOBCAB (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)
PROCEDURECABG (coronary artery bypass grafting)
conventional CABG with cardiopulmonary bypass
Sponsors
Deutsche Stiftung für Herzforschung
University of Wuerzburg
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| occurrence and number of cerebral infarctions assessed by magnetic resonance imaging | 2-7 days after surgery |
Secondary
| Measure | Time frame |
|---|---|
| stroke | within hospital stay following surgery |
| delirium | within hospital stay following surgery |
| neurocognitive performance | within hospital stay following surgery |
| mortality | within hospital stay following surgery |
| myocardial infarction | within hospital stay following surgery |
| completeness of revascularisation | within hospital stay following surgery |
| multi-organ failure | within hospital stay following surgery |
Countries
Germany
Contacts
Primary ContactWilko Reents, MD
Outcome results
None listed