Surgical Manipulation of the Aorta and Cerebral Infarction

Surgical Manipulation of the Ascending Aorta and Cerebral Infarction Following CABG

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

Study Overview

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

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 Type: Interventional
• Enrollment (Anticipated): 200
• Phase: Phase 2

Contacts and Locations

Study Locations

• Germany
  • Wuerzburg, Germany, 97080
    • Recruiting
    • Department of Cardiothoracic Surgery, University Hospital Wuerzburg
    • Contact: Wilko Reents, MD; Phone Number: 0049-931-201-33001; Email: reents_w@klinik.uni-wuerzburg.de
    • Principal Investigator: Wilko Reents, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 1	Procedure: 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)
Active Comparator: 2	Procedure: CABG (coronary artery bypass grafting); conventional CABG with cardiopulmonary bypass

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
occurrence and number of cerebral infarctions assessed by magnetic resonance imaging	2-7 days after surgery

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: University of Wuerzburg
• Collaborators: Deutsche Stiftung für Herzforschung
• Investigators: Principal Investigator: Wilko Reents, MD, Department of Cardiothoracic Surgery

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: November 1, 2007
• Primary Completion: December 7, 2022
• Study Completion (Anticipated): May 1, 2010

Study Registration Dates

• First Submitted: November 14, 2007
• First Submitted That Met QC Criteria: November 14, 2007
• First Posted (Estimate): November 15, 2007

Study Record Updates

• Last Update Posted (Estimate): November 22, 2007
• Last Update Submitted That Met QC Criteria: November 21, 2007
• Last Verified: November 1, 2007

More Information

Terms related to this study

• Keywords: Coronary artery bypass; off pump coronary artery bypass grafting (OPCAB)
• Additional Relevant MeSH Terms: Ischemia; Pathologic Processes; Necrosis; Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Brain Ischemia; Stroke; Brain Infarction; Infarction; Heart Diseases; Coronary Artery Disease; Myocardial Ischemia; Coronary Disease; Cerebral Infarction
• Other Study ID Numbers: 49/07; F/13/03

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No