NCT00123539

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

Estradiol for Neurocognitive Dysfunction After CABG

• Status: Terminated
• Phase: N/A
• Study type: Interventional
• Enrollment: 334 (planned)
• Sponsor: National Heart, Lung, and Blood Institute (NHLBI) · NIH
• Sex: Female
• Age: 55 Years
• Healthy volunteers: Not accepted

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 mortality of surgery for women is due to perioperative neurologic injury. Estrogen has been consistently shown to reduce the extent of neurologic injury in a variety of in vitro and animal experimental stroke models. These data together strongly suggest that the higher risk for perioperative neurologic complications for elderly women may relate to their estrogen deficient state. DESIGN NARRATIVE: This randomized, placebo controlled study will test the hypothesis that perioperative estrogen replacement in postmenopausal women reduces the risk for neurologic injury after CABG surgery. Three hundred thirty-four women undergoing CABG surgery will be prospectively randomized to receive either 17 beta-estradiol or placebo in a double-blind fashion beginning the day before surgery and continuing for 5 days after surgery. Patients will be assessed for neurocognitive dysfunction, which is the most common manifestation of neurologic injury from cardiac surgery. Neurocognitive testing will be performed 1 to 2 days before surgery, 4 to 6 weeks postoperatively, and 6 months after surgery. The primary endpoint will be neurocognitive function 4 to 6 weeks after surgery for women who received 17 beta- estradiol compared with placebo perioperatively. The trial will also evaluate the importance of postoperative cognitive decline on measures of cognitive function and quality of life 6 months after surgery, and whether perioperative 17 beta-estradiol treatment improves these outcomes.

Conditions

• Coronary Disease
• Cardiovascular Diseases
• Heart Diseases
• Neurologic Manifestations

Interventions

Type	Name	Description
DRUG	Estrogen Replacement Therapy
PROCEDURE	Surgery

Timeline

• Start date: 2001-06-01
• Completion: 2005-08-01
• First posted: 2005-07-25
• Last updated: 2016-07-29

Locations

1 site across 1 country: United States