Surgical Manipulation of the Aorta and Cerebral Infarction

The recruitment status of this study is unknown because the information has not been verified recently.

Verified November 2007 by University of Wuerzburg.
Recruitment status was Recruiting

Sponsor:

Collaborator:

Deutsche Stiftung für Herzforschung

Information provided by:

University of Wuerzburg

ClinicalTrials.gov Identifier:

NCT00558779

First received: November 14, 2007

Last updated: November 21, 2007

Last verified: November 2007

History of Changes

Purpose

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

Condition	Intervention	Phase
Coronary Heart Disease Stroke Cerebral Infarction	Procedure: OBCAB (Off Pump Coronary Artery Bypass Grafting) Procedure: CABG (coronary artery bypass grafting)	Phase 2

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Single Blind (Outcomes Assessor) Primary Purpose: Treatment
Official Title:	Surgical Manipulation of the Ascending Aorta and Cerebral Infarction Following CABG

Resource links provided by NLM:

MedlinePlus related topics: Coronary Artery Bypass Surgery Coronary Artery Disease Heart Diseases MRI Scans

U.S. FDA Resources

Further study details as provided by University of Wuerzburg:

Primary Outcome Measures:

occurrence and number of cerebral infarctions assessed by magnetic resonance imaging [ Time Frame: 2-7 days after surgery ]

Secondary Outcome Measures:

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

Estimated Enrollment:	200
Study Start Date:	November 2007
Estimated Study Completion Date:	May 2010

Arms	Assigned Interventions
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

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

Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00558779

Contacts

Contact: Wilko Reents, MD

0049 - 931 - 201 - 33001

reents_w@klinik.uni-wuerzburg.de

Locations

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

Sponsors and Collaborators

University of Wuerzburg

Deutsche Stiftung für Herzforschung

Investigators

Principal Investigator:

Wilko Reents, MD

Department of Cardiothoracic Surgery

More Information

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.

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.

Calafiore AM, Di Mauro M, Teodori G, Di Giammarco G, Cirmeni S, Contini M, Iacò 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.

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.

Bendszus M, Reents W, Franke D, Müllges 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.

ClinicalTrials.gov Identifier:	NCT00558779 History of Changes
Other Study ID Numbers:	49/07, F/13/03
Study First Received:	November 14, 2007
Last Updated:	November 21, 2007
Health Authority:	Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by University of Wuerzburg:

Coronary artery bypass
off pump coronary artery bypass grafting (OPCAB)

Additional relevant MeSH terms:

Cerebral Infarction
Stroke
Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Heart Diseases
Infarction
Brain Infarction
Brain Ischemia
Cerebrovascular Disorders

Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Ischemia
Pathologic Processes
Necrosis

ClinicalTrials.gov processed this record on May 22, 2013

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