Status:
TERMINATED
Estrogen Replacement to Reduce Risk of Neurologic Injury After Coronary Artery Bypass Graft Surgery
Lead Sponsor:
National Heart, Lung, and Blood Institute (NHLBI)
Conditions:
Coronary Disease
Cardiovascular Diseases
Eligibility:
FEMALE
55+ years
Phase:
NA
Brief Summary
The purpose of this study is to test whether perioperative estrogen replacement in postmenopausal women reduces the risk for neurologic injury after coronary artery bypass graft (CABG) surgery.
Detailed Description
BACKGROUND: Women undergoing CABG surgery have a higher operative mortality rate, longer hospitalizations, and higher hospital costs compared with men. A large proportion of this excess morbidity and...
Eligibility Criteria
Inclusion
- Patients whose scheduled procedure is CABG surgery OR
- Patients whose scheduled procedure is isolated aortic surgery OR
- Patients whose scheduled procedure is mitral valve surgery OR
- Patients whose scheduled procedure is CABG combined with aortic or mitral valve surgery
Exclusion
- Patients having re-operations
- Patients having combined carotid endarterectomy with CABG surgery
- Patients having CABG with tricuspid valve surgery
- Patients having mitral and aortic valvular surgery (with or without CABG surgery)
- Elevation of liver function test before surgery or creatinine before surgery greater than 2 mg/dl
- Emergency surgery
- Severe cognitive impairment before surgery as indicated by clinical history and/or a score greater than 12 on the Short Blessed Dementia Screening Test (see d11)
- Inability to attend outpatient visits
- A history of venous thromboembolism
- Unexplained vaginal bleeding
- A history of breast cancer or personal history of endometrial cancer in the absence of hysterectomy
- Estrogen use within 6 months of the surgery
- Patient refusal to participate
- Inability to speak and read English or visual impairment
Key Trial Info
Start Date :
June 1 2001
Trial Type :
INTERVENTIONAL
End Date :
August 1 2005
Estimated Enrollment :
334 Patients enrolled
Trial Details
Trial ID
NCT00123539
Start Date
June 1 2001
End Date
August 1 2005
Last Update
July 29 2016
Active Locations (1)
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1
Washington University
St Louis, Missouri, United States, 63110