Estrogen Replacement to Reduce Risk of Neurologic Injury After Coronary Artery Bypass Graft Surgery
Stopped early · Not applicable
Conditions studied: Coronary Disease, Cardiovascular Diseases, Heart Diseases, Neurologic Manifestations
In brief
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.
Key facts
- Study ID
- NCT00123539
- Run by
- National Heart, Lung, and Blood Institute (NHLBI)
- People needed
- 334
- Starts
- 2001-06-01
- Expected to finish
- 2005-08-01
- Last updated by the study team
- 2016-07-29
Who can join
Age: 55 and older. Sex: female. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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
Where it is running
- Washington University — St Louis, Missouri, United States
Full record on ClinicalTrials.gov
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