- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00558779
Surgical Manipulation of the Aorta and Cerebral Infarction
Surgical Manipulation of the Ascending Aorta and Cerebral Infarction Following CABG
Study Overview
Status
Conditions
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
Enrollment (Anticipated)
Phase
- Phase 2
Contacts and Locations
Study Contact
- Name: Wilko Reents, MD
- Phone Number: 0049 - 931 - 201 - 33001
- Email: reents_w@klinik.uni-wuerzburg.de
Study Locations
-
-
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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
Genders Eligible for Study
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
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: 1
|
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
|
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
Time Frame: 2-7 days after surgery
|
2-7 days after surgery
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
mortality
Time Frame: within hospital stay following surgery
|
within hospital stay following surgery
|
stroke
Time Frame: within hospital stay following surgery
|
within hospital stay following surgery
|
delirium
Time Frame: within hospital stay following surgery
|
within hospital stay following surgery
|
neurocognitive performance
Time Frame: within hospital stay following surgery
|
within hospital stay following surgery
|
multi-organ failure
Time Frame: within hospital stay following surgery
|
within hospital stay following surgery
|
myocardial infarction
Time Frame: within hospital stay following surgery
|
within hospital stay following surgery
|
completeness of revascularisation
Time Frame: within hospital stay following surgery
|
within hospital stay following surgery
|
Collaborators and Investigators
Sponsor
Collaborators
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
Primary Completion
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
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
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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