Overview

Estrogen Replacement to Reduce Risk of Neurologic Injury After Coronary Artery Bypass Graft Surgery

Status:
Terminated
Trial end date:
2005-08-01
Target enrollment:
0
Participant gender:
Female
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.
Phase:
N/A
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
National Heart, Lung, and Blood Institute (NHLBI)
Treatments:
Estrogens
Criteria
Inclusion Criteria:

- 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 Criteria:

- 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