Surgical Manipulation of the Aorta and Cerebral Infarction

Phase 2

• Conditions: Coronary Heart Disease; Stroke; Cerebral Infarction
• Interventions: Procedure: CABG (coronary artery bypass grafting); Procedure: OBCAB (Off Pump Coronary Artery Bypass Grafting)

• Registration Number: NCT00558779
• Lead Sponsor: 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

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.

Study Timeline

• Status Verified: 2007-11
• Study Start: 2007-11
• Study First Submitted: 2007-11-14
• Study First Submitted QC: 2007-11-14
• Study First Posted: 2007-11-15
• Last Update Submitted: 2007-11-21
• Last Update Posted: 2007-11-22
• Study Completion: 2010-05

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 200

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
2	CABG (coronary artery bypass grafting)	-
1	OBCAB (Off Pump Coronary Artery Bypass Grafting)	-

Primary Outcome Measures

Name	Time	Method
occurrence and number of cerebral infarctions assessed by magnetic resonance imaging	2-7 days after surgery

Secondary Outcome Measures

Name	Time	Method
delirium	within hospital stay following surgery
myocardial infarction	within hospital stay following surgery
stroke	within hospital stay following surgery
completeness of revascularisation	within hospital stay following surgery
mortality	within hospital stay following surgery
neurocognitive performance	within hospital stay following surgery
multi-organ failure	within hospital stay following surgery

Trial Locations

Locations (1)

Department of Cardiothoracic Surgery, University Hospital Wuerzburg; 🇩🇪 Wuerzburg, Germany