Surgical Manipulation of the Aorta and Cerebral Infarction

Recruiting

Phase 2 Results N/A

Trial Description

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.

Conditions

Interventions

  • OBCAB (Off Pump Coronary Artery Bypass Grafting) Procedure
    Intervention Desc: 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)
    ARM 1: Kind: Experimental
    Label: 1
  • CABG (coronary artery bypass grafting) Procedure
    Intervention Desc: conventional CABG with cardiopulmonary bypass
    ARM 1: Kind: Experimental
    Label: 2

Trial Design

  • Allocation: Randomized
  • Masking: Single Blind (Outcomes Assessor)
  • Purpose: Treatment
  • Endpoint: Efficacy Study
  • Intervention: Parallel Assignment

Outcomes

Type Measure Time Frame Safety Issue
Primary occurrence and number of cerebral infarctions assessed by magnetic resonance imaging 2-7 days after surgery
Secondary mortality within hospital stay following surgery
Secondary stroke within hospital stay following surgery
Secondary delirium within hospital stay following surgery
Secondary neurocognitive performance within hospital stay following surgery
Secondary multi-organ failure within hospital stay following surgery
Secondary myocardial infarction within hospital stay following surgery
Secondary completeness of revascularisation within hospital stay following surgery

Sponsors