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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
  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:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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:
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
Coronary Artery Disease
Coronary Disease
Heart Diseases
Infarction
Myocardial Ischemia
Stroke
Arterial Occlusive Diseases
Arteriosclerosis
Brain Diseases
Brain Infarction
Brain Ischemia
Cardiovascular Diseases
Central Nervous System Diseases
Cerebrovascular Disorders
Ischemia
Necrosis
Nervous System Diseases
Pathologic Processes
Vascular Diseases

ClinicalTrials.gov processed this record on November 25, 2014