Status:
COMPLETED
Improving Neurologic Outcomes in People With Diabetes Who Are Undergoing Heart Surgery
Lead Sponsor:
National Heart, Lung, and Blood Institute (NHLBI)
Conditions:
Diabetes Mellitus
Cardiovascular Diseases
Eligibility:
All Genders
35+ years
Phase:
PHASE3
Brief Summary
Preliminary studies have shown that people with diabetes who undergo heart surgery may have a higher risk of developing cognitive functioning problems, including memory problems, than people without d...
Detailed Description
People with diabetes who undergo heart surgery have a greater risk of experiencing a stroke and developing cognitive functioning problems than people without diabetes who undergo heart surgery. There ...
Eligibility Criteria
Inclusion
- History of diabetes, elevated fasting blood glucose, elevated hemoglobin A1c, or elevation of these variables during the current hospital admission
- Scheduled to undergo coronary artery bypass graft (CABG) surgery
- Scheduled to undergo aortic valve replacement (AVR), mitral valve replacement (MVR), or both
- Scheduled to undergo valve replacement with CABG
Exclusion
- Undergoing emergent (i.e., urgent) procedures
- Alzheimer's disease or similar dementias
- Severe claustrophobia
- Kidney insufficiency, as defined by serum creatine levels greater than 2.0 mg/dL
- Cannot be expected to complete neuropsychological testing
- Recent extensive, life threatening acute myocardial infarction (AMI)
Key Trial Info
Start Date :
December 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2014
Estimated Enrollment :
133 Patients enrolled
Trial Details
Trial ID
NCT00836329
Start Date
December 1 2008
End Date
May 1 2014
Last Update
July 12 2016
Active Locations (1)
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1
Wake Forest Baptist Medical Center
Winston-Salem, North Carolina, United States, 27057