Estrogen Replacement to Reduce Risk of Neurologic Injury After Coronary Artery Bypass Graft Surgery
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|ClinicalTrials.gov Identifier: NCT00123539|
Recruitment Status : Terminated (DSMB stopped the study based on conclusion of likely futility of treatment on the primary outcome.)
First Posted : July 25, 2005
Last Update Posted : July 29, 2016
|Condition or disease||Intervention/treatment||Phase|
|Coronary Disease Cardiovascular Diseases Heart Diseases Neurologic Manifestations||Drug: Estrogen Replacement Therapy Procedure: Surgery||Not Applicable|
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.
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.
|Study Type :||Interventional (Clinical Trial)|
|Enrollment :||334 participants|
|Official Title:||Estradiol for Neurocognitive Dysfunction After CABG|
|Study Start Date :||June 2001|
|Actual Study Completion Date :||August 2005|
- Neurocognitive function (measured 4 to 6 weeks after surgery)
- Cognitive function
- Quality of life (measured 6 months after surgery)
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00123539
|United States, Missouri|
|St. Louis, Missouri, United States, 63110|
|Principal Investigator:||Charles W. Hogue, Jr., MD||Department of Anesthesiology and Critical Care Medicine, The Johns Hopkins University School of Medicine|