Surgical Manipulation of the Aorta and Cerebral Infarction
Primary Purpose
Coronary Heart Disease, Stroke, Cerebral Infarction
Status
Unknown status
Phase
Phase 2
Locations
Germany
Study Type
Interventional
Intervention
OBCAB (Off Pump Coronary Artery Bypass Grafting)
CABG (coronary artery bypass grafting)
Sponsored by
About this trial
This is an interventional treatment trial for Coronary Heart Disease focused on measuring Coronary artery bypass, off pump coronary artery bypass grafting (OPCAB)
Eligibility 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.
Sites / Locations
- Department of Cardiothoracic Surgery, University Hospital WuerzburgRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
1
2
Arm Description
Outcomes
Primary Outcome Measures
occurrence and number of cerebral infarctions assessed by magnetic resonance imaging
Secondary Outcome Measures
mortality
stroke
delirium
neurocognitive performance
multi-organ failure
myocardial infarction
completeness of revascularisation
Full Information
NCT ID
NCT00558779
First Posted
November 14, 2007
Last Updated
November 21, 2007
Sponsor
University of Wuerzburg
Collaborators
Deutsche Stiftung für Herzforschung
1. Study Identification
Unique Protocol Identification Number
NCT00558779
Brief Title
Surgical Manipulation of the Aorta and Cerebral Infarction
Official Title
Surgical Manipulation of the Ascending Aorta and Cerebral Infarction Following CABG
Study Type
Interventional
2. Study Status
Record Verification Date
November 2007
Overall Recruitment Status
Unknown status
Study Start Date
November 2007 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
May 2010 (Anticipated)
3. Sponsor/Collaborators
Name of the Sponsor
University of Wuerzburg
Collaborators
Deutsche Stiftung für Herzforschung
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Coronary Heart Disease, Stroke, Cerebral Infarction
Keywords
Coronary artery bypass, off pump coronary artery bypass grafting (OPCAB)
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
200 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Experimental
Arm Title
2
Arm Type
Active Comparator
Intervention Type
Procedure
Intervention Name(s)
OBCAB (Off Pump Coronary Artery Bypass Grafting)
Intervention Description
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)
Intervention Type
Procedure
Intervention Name(s)
CABG (coronary artery bypass grafting)
Intervention Description
conventional CABG with cardiopulmonary bypass
Primary Outcome Measure Information:
Title
occurrence and number of cerebral infarctions assessed by magnetic resonance imaging
Time Frame
2-7 days after surgery
Secondary Outcome Measure Information:
Title
mortality
Time Frame
within hospital stay following surgery
Title
stroke
Time Frame
within hospital stay following surgery
Title
delirium
Time Frame
within hospital stay following surgery
Title
neurocognitive performance
Time Frame
within hospital stay following surgery
Title
multi-organ failure
Time Frame
within hospital stay following surgery
Title
myocardial infarction
Time Frame
within hospital stay following surgery
Title
completeness of revascularisation
Time Frame
within hospital stay following surgery
10. Eligibility
Sex
All
Accepts Healthy Volunteers
No
Eligibility 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Wilko Reents, MD
Phone
0049 - 931 - 201 - 33001
Email
reents_w@klinik.uni-wuerzburg.de
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Wilko Reents, MD
Organizational Affiliation
Department of Cardiothoracic Surgery
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Cardiothoracic Surgery, University Hospital Wuerzburg
City
Wuerzburg
ZIP/Postal Code
97080
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Wilko Reents, MD
Phone
0049-931-201-33001
Email
reents_w@klinik.uni-wuerzburg.de
First Name & Middle Initial & Last Name & Degree
Wilko Reents, MD
12. IPD Sharing Statement
Citations:
PubMed Identifier
11441193
Citation
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.
Results Reference
background
PubMed Identifier
8948560
Citation
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.
Results Reference
background
PubMed Identifier
12022522
Citation
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.
Results Reference
background
PubMed Identifier
15927994
Citation
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.
Results Reference
background
PubMed Identifier
12117356
Citation
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.
Results Reference
background
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Surgical Manipulation of the Aorta and Cerebral Infarction
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