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Main
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Note: This record shows only the 20 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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17 October 2012 |
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Main ID: |
NCT00558779 |
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Date of registration:
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14/11/2007 |
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Primary sponsor: |
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Public title:
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Surgical Manipulation of the Aorta and Cerebral Infarction
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Scientific title:
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Surgical Manipulation of the Ascending Aorta and Cerebral Infarction Following CABG |
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Date of first enrolment:
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November 2007 |
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Target sample size:
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200 |
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Recruitment status: |
Recruiting |
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URL:
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http://clinicaltrials.gov/show/NCT00558779 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment
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Countries of recruitment
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Germany
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Contacts
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Name:
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Wilko Reents, MD |
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Address:
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Telephone:
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0049-931-201-33001 |
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Email:
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reents_w@klinik.uni-wuerzburg.de |
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Affiliation:
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Name:
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Wilko Reents, MD |
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Address:
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Telephone:
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0049 - 931 - 201 - 33001 |
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Email:
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reents_w@klinik.uni-wuerzburg.de |
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Affiliation:
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Name:
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Wilko Reents, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Department of Cardiothoracic Surgery |
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Key inclusion & exclusion criteria
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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.
Age minimum:
N/A
Age maximum:
N/A
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Cerebral Infarction
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Coronary Heart Disease
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Stroke
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Intervention(s)
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Procedure: CABG (coronary artery bypass grafting)
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Procedure: OBCAB (Off Pump Coronary Artery Bypass Grafting)
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Primary Outcome(s)
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occurrence and number of cerebral infarctions assessed by magnetic resonance imaging
[Time Frame: 2-7 days after surgery]
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Secondary Outcome(s)
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completeness of revascularisation
[Time Frame: within hospital stay following surgery]
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delirium
[Time Frame: within hospital stay following surgery]
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mortality
[Time Frame: within hospital stay following surgery]
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multi-organ failure
[Time Frame: within hospital stay following surgery]
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myocardial infarction
[Time Frame: within hospital stay following surgery]
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neurocognitive performance
[Time Frame: within hospital stay following surgery]
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stroke
[Time Frame: within hospital stay following surgery]
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Secondary ID(s)
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49/07
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F/13/03
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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